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Background: Geriatric malnutrition in hospitals is common and can be affected by many things, including poor satisfaction toward hospital foodservice. Hospital foodservice plays an important role in a patient's recovery process by providing adequate nutrients. On top of that, patients' foodservice satisfaction can easily be afflicted by the quality of food served and the overall foodservice experience. Furthermore, malnutrition can occur from poor foodservice quality, especially among geriatric patients. Objective: This study aims to assess the effectiveness of the Malaysian Geriatric Patients' Hospital Foodservice Protocol (MYGERYFS). Methods: The protocol comprises 3 phases. Phase One is a cross-sectional study that took place at public hospitals with geriatric wards in the Klang Valley. Univariate data from Phase One were analyzed descriptively. Pearson correlation and chi-square were conducted to find factors associated with foodservice satisfaction. Phase Two involves the collaboration of health care professionals in the geriatric field. In Phase Three, a feasibility study will be conducted to determine the feasibility of the MYGERYFS protocol in a hospital among 60 geriatric patients. These patients will be randomized into control and intervention groups, respectively. Intervention care will be done to ensure the safety of the protocol. Results: Data collection for Phase One of the study has been completed. A total of 233 geriatric respondents with the mean age of 71.39 (SD 7.99) years were gathered. Approximately 51.5% (n=120) of the respondents were female, while 48.5% (n=113) were male, with a mean BMI of 24.84 (SD 6.05) kg/m2. Their mean energy and protein intakes were 1006.20 kcal (SD 462.03 kcal) and 42.60 (SD 22.20) grams, respectively. Based on the Mini Nutritional Assessment, older patients who scored 12-14 (normal) were 27.9% (n=65), those who scored 8-11 (at risk) were 54.9% (n=128), and those who scored 0-7, which is the lowest (malnutrition), were 17.2% (n=40) of the study population. Hence, most patients were at risk of malnutrition. Although a majority of the patients claimed to have good foodservice satisfaction 26.2% (n=61), they also experienced at least 3 barriers during mealtimes. It was found that dietary intake and mealtime barriers were significantly associated with the respondent's foodservice satisfaction. Data for Phase Two and Phase Three are yet to be collected and analyzed. Conclusions: This study protocol could potentially benefit the hospital foodservice system and aid in improving geriatric nutritional status. [ABSTRACT FROM AUTHOR]

Background: Improving childhood health is complex due to the multifactorial nature and interaction of determinants. Complex problems call for complex intervention thinking, and simple one-size-fits-all solutions do not work to improve childhood health. Early awareness is important, as behavior in childhood often is manifested across adolescence and into adulthood. To facilitate shared understanding of the complex structures and relationships that determine children's health behavior, participatory system approaches in, for example, local communities have shown promising potential. However, such approaches are not used systematically within public health in Denmark, and before being rolled out, they should be tested for their feasibility within this context. Objective: This paper describes the study design for Children's Cooperation Denmark (Child-COOP) feasibility study that is aiming to examine the feasibility and acceptability of the participatory system approach and the study procedures for a future scale-up controlled trial. Methods: The feasibility study is designed as a process evaluation of the intervention with the use of both qualitative and quantitative methods. A local childhood health profile will provide data for childhood health issues, for example, daily physical activity behavior, sleep patterns, anthropometry, mental health, screen use, parental support, and leisure-time activities. Data at system level are collected to assess development in the community, for example, readiness to change, analysis of social networks with stakeholders, rippled effects mapping, and changes in system map. The setting is a small rural town in Denmark, Havndal, with children as the primary target group. Group model building, a participatory system dynamics method, will be used to engage the community, create consensus on the drivers of childhood health, identify local opportunities, and develop context-specific actions. Results: The Child-COOP feasibility study will test the participatory system dynamics approach for intervention and evaluation design and survey objective measures of childhood health behavior and well-being among the ~100 children (6-13 years) attending the local primary school. Community-level data will also be collected. We will assess the contextual factors, implementation of interventions, and mechanisms of impact as part of a process evaluation. Data will be collected at baseline, at 2 years, and 4 years of follow-up. Ethical approval for this study was sought and granted from the Danish Scientific Ethical Committee (1-10-72-283-21). Conclusions: s: The potential of this participatory system dynamics approach includes opportunities for community engagement and local capacity building to improve children's health and health behavior, and this feasibility study holds the potential to prepare an upscaling of the intervention for effectiveness testing. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic disrupted the delivery of diabetes care and worsened mental health among many patients with type 2 diabetes (T2D). This disruption puts patients with T2D at risk for poor diabetes outcomes, especially those who experience social disadvantage due to socioeconomic class, rurality, or ethnicity. The appropriate use of communication technology could reduce these gaps in diabetes care created by the pandemic and also provide support for psychological distress. Objective: The purpose of this study is to test the feasibility of an innovative co-designed Technology-Enabled Collaborative Care (TECC) model for diabetes management and mental health support among adults with T2D. Methods: We will recruit 30 adults with T2D residing in Ontario, Canada, to participate in our sequential explanatory mixed methods study. They will participate in 8 weekly web-based health coaching sessions with a registered nurse, who is a certified diabetes educator, who will be supported by a digital care team (ie, a peer mentor, an addictions specialist, a dietitian, a psychiatrist, and a psychotherapist). Assessments will be completed at baseline, 4 weeks, and 8 weeks, with a 12-week follow-up. Our primary outcome is the feasibility and acceptability of the intervention, as evident by the participant recruitment and retention rates. Key secondary outcomes include assessment completion and delivery of the intervention. Exploratory outcomes consist of changes in mental health, substance use, and physical health behaviors. Stakeholder experience and satisfaction will be explored through a qualitative descriptive study using one-on-one interviews. Results: This paper describes the protocol of the study. The recruitment commenced in June 2021. This study was registered on October 29, 2020, on ClinicalTrials.gov (Registry ID: NCT04607915). As of June 2022, all participants have been recruited. It is anticipated that data analysis will be complete by the end of 2022, with study findings available by the end of 2023. Conclusions: The development of an innovative, technology-enabled model will provide necessary support for individuals living with T2D and mental health challenges. This TECC program will determine the feasibility of TECC for patients with T2D and mental health issues. [ABSTRACT FROM AUTHOR]

Background: Women with intellectual and developmental disabilities (IDD) do not undergo breast and cervical cancer screening at the same rate as women without IDD. IDDs are diagnosed in childhood, are lifelong, and involve difficulties in adaptive behaviors and intellectual functioning. Native American women also experience disparities in breast and cervical cancer screenings. Despite known disparities, women with IDD are often not included in health promotion programs, and there is a need for evidence-based programming for those with intersectional identities, such as Native American women with IDD. Objective: This study aims to assess the feasibility and acceptability of My Health My Choice (MHMC), an adaptation of the Women Be Healthy 2 program. There are 2 parts to the study: adaptation of the Women Be Healthy 2 program and feasibility and acceptability testing of MHMC. Methods: Individuals aged over 18 years who identify as Native American females with IDD and their caregivers (N=30 women-caregiver dyads) are eligible for the study. Participants, who are affiliated with 2 partnering sites in Arizona (1 rural and 1 urban), complete pre- and postsurveys assessing knowledge, self-efficacy, and screening expectations before and immediately after completing the program. In addition, all participants complete brief satisfaction surveys after each of the 6 educational sessions. A subsample of Native American women with an IDD (n=12), caregivers (n=12), and community health educators (n=2) who participate in the MHMC program will provide semistructured qualitative input regarding the content, delivery, and cultural relevance of the program. Results: The adaptation of the culturally responsive MHMC program was completed in August 2021. In November 2021, the project team began recruitment for feasibility and acceptability studies. Feasibility will be examined using participation metrics, and acceptability will be measured using satisfaction measures. Pre- and postmeasures in cancer screening knowledge, self-efficacy, and screening expectations will examine improvements among participants. Conclusions: The results of feasibility and acceptability testing of MHMC will guide future implementation studies of the program. [ABSTRACT FROM AUTHOR]

Background: Effective medication management is one of the essential preconditions for enabling polymedicated home-dwelling older adults with multiple chronic conditions to remain at home and preserve their quality of life and autonomy. Lack of effective medication management predisposes older adults to medication-related problems (MRPs) and adverse health outcomes, which can lead to the degradation of a patient's acute clinical condition, physical and cognitive decline, exacerbation of chronic medical conditions, and avoidable health care costs. Nonetheless, it has been shown that MRPs can be prevented or reduced by using well-coordinated, patient-centered, interprofessional primary care interventions. Objective: This study aimed to explore the feasibility and acceptability of an evidence-based, multicomponent, interprofessional intervention program supported by informal caregivers to decrease MRPs among polymedicated home-dwelling older adults with multiple chronic conditions. Methods: This quasi-experimental, pre-post, multisite pilot, and feasibility study will use an open-label design, with participants knowing the study's objectives and relevant information, and it will take place in primary health care settings in Portugal and Switzerland. The research population will comprise 30 polymedicated, home-dwelling adults, aged ≥65 years at risk of MRPs and receiving community-based health care, along with their informal caregivers and health care professionals. Results: Before a projected full-scale study, this pilot and feasibility study will focus on recruiting and ensuring the active collaboration of its participants and on the feasibility of expanding this evidence-based, multicomponent, interprofessional intervention program throughout both study regions. This study will also be essential to projected follow-up research programs on informal caregivers' multiple roles, enhancing their coordination tasks and their own needs. Results are expected at the end of 2024. Conclusions: Designing, establishing, and exploring the feasibility and acceptability of an intervention program to reduce the risks of MRPs among home-dwelling older adults is an underinvestigated issue. Doing so in collaboration with all the different actors involved in that population's medication management and recording the first effects of the intervention will make this pilot and feasibility study's findings very valuable as home care becomes an ever more common solution. [ABSTRACT FROM AUTHOR]

Background: Extensive research suggests that physical activity (PA) is important for brain and cognitive health and may help to delay or prevent Alzheimer's disease and related dementias. Most PA interventions designed to improve brain health in older adults have been conducted in laboratory, gym, or group settings that require extensive resources and travel to the study site or group sessions. Research is needed to develop novel interventions that leverage mobile health (mHealth) technologies to help older adults increase their engagement in PA in free-living environments, reducing participant burden and increasing generalizability of research findings. Moreover, promoting engagement in moderate-to-vigorous PA (MVPA) may be most beneficial to brain health; thus, using mHealth to help older adults increase time spent in MVPA in free-living environments may help to offset the burden of Alzheimer's disease and related dementias and improve quality of life in older age. Objective: We developed a novel PA intervention that leverages mHealth to help older adults achieve more minutes of MVPA independently. This pilot study was a 12-week randomized controlled trial to investigate the feasibility of providing just-in-time (JIT) feedback about PA intensity during free-living exercise sessions to help older adults meet current PA recommendations (150 minutes per week of MVPA). Methods: Participants were eligible if they were cognitively healthy English speakers aged between 65 and 80 years without major cardiovascular, neurologic, or mental health conditions; could ambulate independently; and undergo magnetic resonance imaging. Enrollment occurred from October 2017 to March 2020. Participants randomized to the PA condition received an individualized exercise prescription and an mHealth device that provided heart rate-based JIT feedback on PA intensity, allowing them to adjust their behavior in real time to maintain MVPA during exercise sessions. Participants assigned to the healthy aging education condition received a reading prescription consisting of healthy aging topics and completed weekly quizzes based on the materials. Results: In total, 44 participants were randomized to the intervention. A follow-up manuscript will describe the results of the intervention as well as discuss screening, recruitment, adverse events, and participants' opinions regarding their participation in the intervention. Conclusions: The long-term goal of this intervention is to better understand how MVPA affects brain and cognitive health in the real world and extend laboratory findings to everyday life. This pilot randomized controlled trial was conducted to determine the feasibility of using JIT heart rate zone feedback to help older adults independently increase time spent in MVPA while collecting data on the plausible mechanisms of change (frontal and medial temporal cerebral blood flow and cardiorespiratory fitness) that may affect cognition (memory and executive function) to help refine a planned stage 2 behavioral trial. [ABSTRACT FROM AUTHOR]

Background: Nondaily smoking is a widespread, increasingly prevalent pattern of smoking, particularly in ethnic minority and vulnerable populations. To date, no effective treatment approach for this type of smokers has been identified. Objective: This study aims to use a randomized controlled trial to evaluate proof-of-concept markers of the Smiling instead of Smoking (SiS) app, a smoking cessation smartphone app designed specifically for nondaily smokers. This app was developed iteratively and is now in its third version. Previous studies have demonstrated acceptability and feasibility when participants were onboarded in person (study 1) and remotely (study 2) and showed within-person changes in line with hypothesized mechanisms of change. This is the first randomized test of this app. Methods: In total, 225 adult nondaily smokers will be asked to undertake a quit attempt while using smoking cessation support materials for a period of 7 weeks. Participants will be randomized to use the SiS smartphone app, the National Cancer Institute smartphone app QuitGuide, or the National Cancer Institute smoking cessation brochure "Clearing the Air." Participants will take part in a 15-minute scripted onboarding phone call during which study staff will introduce participants to their support materials. Survey links will be sent 2, 6, 12, and 24 weeks after the participants' initially chosen quit date. The primary outcome is self-efficacy to remain abstinent from smoking at treatment end, measured using the Smoking Self-Efficacy Questionnaire. Secondary outcomes cover several domains relevant to treatment development and implementation: treatment acceptability (eg, satisfaction with smoking cessation support, measured using the Client Satisfaction Questionnaire, and app usability, measured using the System Usability Scale); treatment feasibility (eg, measured using the number of days participants used the SiS or QuitGuide app during the prescribed treatment period); and, in an exploratory way, treatment efficacy assessed using self-reported 30-day point prevalence abstinence. Results: Recruitment began in January 2021 and ended June 2022. The final 24-week follow-up was completed in January 2023. This trial is funded by the American Cancer Society. Conclusions: This study is designed to test whether the prescribed use of the SiS app results in greater self-efficacy to abstain from smoking in nondaily smokers than commonly recommended alternative treatments and whether the SiS app treatment is acceptable and feasible. Positive results will mean that the SiS app warrants testing in a large-scale randomized controlled trial to test its effectiveness in supporting smoking cessation in nondaily smokers. The design of this study also provides insights into issues pertinent to smoking cessation smartphone app treatment development and implementation by measuring, in a randomized design, markers of treatment satisfaction, engagement with the technology and content of the treatment, and adherence to the treatment plan. [ABSTRACT FROM AUTHOR]

Background: Unmet pediatric mental health (MH) needs are growing as rates of pediatric depression and anxiety dramatically increase. Access to care is limited by multiple factors, including a shortage of clinicians trained in developmentally specific, evidence-based services. Novel approaches to MH care delivery, including technology-leveraged and readily accessible options, need to be evaluated in service of expanding evidence-based services to youths and their families. Preliminary evidence supports the use of Woebot, a relational agent that digitally delivers guided cognitive behavioral therapy (CBT) through a mobile app, for adults with MH concerns. However, no studies have evaluated the feasibility and acceptability of such app-delivered relational agents specifically for adolescents with depression and/or anxiety within an outpatient MH clinic, nor compared them to other MH support services. Objective: This paper describes the protocol for a randomized controlled trial evaluating the feasibility and acceptability of an investigational device, Woebot for Adolescents (W-GenZD), within an outpatient MH clinic for youths presenting with depression and/or anxiety. The study's secondary aim will compare the clinical outcomes of self-reported depressive symptoms with W-GenZD and a telehealth-delivered CBT-based skills group (CBT-group). Tertiary aims will evaluate additional clinical outcomes and therapeutic alliance between adolescents in W-GenZD and the CBT-group. Methods: Participants include youths aged 13-17 years with depression and/or anxiety seeking care from an outpatient MH clinic at a children's hospital. Eligible youths will have no recent safety concerns or complex comorbid clinical diagnoses; have no concurrent individual therapy; and, if on medications, are on stable doses, based on clinical screening and as well as study-specific criteria. Results: Recruitment began in May 2022. As of December 8, 2022, we have randomized 133 participants. Conclusions: Establishing the feasibility and acceptability of W-GenZD within an outpatient MH clinical setting will add to the field's current understanding of the utility and implementation considerations of this MH care service modality. The study will also evaluate the noninferiority of W-GenZD against the CBT-group. Findings may also have implications for patients, families, and providers looking for additional MH support options for adolescents seeking help for their depression and/or anxiety. Such options expand the menu of supports for youths with lower-intensity needs as well as possibly reduce waitlists and optimize clinician deployment toward more severe cases. [ABSTRACT FROM AUTHOR]

Background: Transmission of drug-resistant tuberculosis (DR-TB) is ongoing. Finding individuals with DR-TB and initiating treatment as early as possible is important to improve patient clinical outcomes and to break the chain of transmission to control the pandemic. To our knowledge systematic reviews assessing effectiveness, cost-effectiveness, acceptability, and feasibility of different case-finding strategies for DR-TB to inform research, policy, and practice have not been conducted, and it is unknown whether enough research exists to conduct such reviews. It is unknown whether case-finding strategies are similar for DR-TB and drug-susceptible TB and whether we can draw on findings from drug-susceptible reviews to inform decisions on case-finding strategies for DR-TB. Objective: This protocol aims to describe the available literature on case-finding for DR-TB and to describe case-finding strategies. Methods: We will screen systematic reviews, trials, qualitative studies, diagnostic test accuracy studies, and other primary research that specifically sought to improve DR-TB case detection. We will exclude studies that invited individuals seeking care for TB symptoms, those including individuals already diagnosed with TB, or laboratory-based studies. We will search the academic databases including MEDLINE, Embase, The Cochrane Library, Africa-Wide Information, CINAHL, Epistemonikos, and PROSPERO with no language or date restrictions. We will screen titles, abstracts, and full-text articles in duplicate. Data extraction and analyses will be performed using Excel (Microsoft Corp). Results: We will provide a narrative report with supporting figures or tables to summarize the data. A systems-based logic model, developed from a synthesis of case-finding strategies for drug-susceptible TB, will be used as a framework to describe different strategies, resulting pathways, and enhancements of pathways. The search will be conducted at the end of 2021. Title and abstract screening, full text screening, and data extraction will be undertaken from January to June 2022. Thereafter, analysis will be conducted, and results compiled. Conclusions: This scoping review will chart existing literature on case-finding for DR-TB—this will help determine whether primary studies on effectiveness, cost-effectiveness, acceptability, and feasibility of different case-finding strategies for DR-TB exist and will help formulate potential questions for a systematic review. We will also describe case-finding strategies for DR-TB and how they fit into a model of case-finding pathways for drug-susceptible TB. This review has some limitations. One limitation is the diverse, inconsistent use of intervention terminology within the literature, which may result in missing relevant studies. Poor reporting of intervention strategies may also cause misunderstanding and misclassification of interventions. Lastly, case-finding strategies for DR-TB may not fit into a model developed from strategies for drug-susceptible TB. Nevertheless, such a situation will provide an opportunity to refine the model for future research. The review will guide further research to inform decisions on case-finding policies and practices for DR-TB. [ABSTRACT FROM AUTHOR]

Background: Physical activity leads to improvements in morbidity, mortality, and quality of life, especially when it is progressive, challenging, and regular. There is strong evidence that strength and balance exercises decrease the risk of falling. However, traditional exercises may be tedious and not very motivating for participants. Exergames have been found to increase engagement and enjoyment for older users. Objective: This study will conduct a feasibility randomized controlled trial (RCT) on the use of MIRA Rehab Exergames among older male residents in a care home setting in Saudi Arabia. A sample of 30 eligible participants will be recruited to meet feasibility study requirements. Methods: We will recruit 38 residents in the care home who will be randomly allocated to either an intervention or a control group. The intervention participants will perform gamified exercises using the MIRA telerehabilitation platform (30 minutes 3 times per week for 6 weeks). The control group will receive educational advice based on booklets of the Otago exercise program and be encouraged to exercise (30 minutes 3 times per week for 6 weeks). Participants will be assessed at weeks 0, 6, and 12. Assessments will include feasibility measures (eligibility, recruitment and attrition rates, and practicalities of data collection methods) and participant outcome measures (balance, strength, mobility, adherence, quality of life, fear of falling, depression, acceptability, and usability). Results: Data collection started in November 2021 and ended in March 2022. The study is currently in the data analysis stage, which commenced in May 2022. The findings from this feasibility RCT will be used to design a definitive RCT to test whether the MIRA Rehab Exergame program benefits older people in Saudi Arabia who may not like participating in traditional exercise programs and may be unwilling or unable to leave their homes. Conclusions: This study will contribute to our understanding of how to recruit in this specific population and provide information to inform the design of a future RCT. [ABSTRACT FROM AUTHOR]

Background: Colombia has a long history of an armed conflict that has severely affected communities with forced internal displacement and violence. Victims of violence and armed conflicts have higher rates of mental health disorders, and children and adolescents are particularly affected. However, the mental health needs of this population are often overlooked, especially in low- and middle-Income countries, where scarcity of resources exacerbates the problem that has been further compounded by the global COVID-19 pandemic. Thus, special attention should be paid to the development of interventions that target this population. Objective: Our research aims to adapt an existing patient-centered digital intervention called DIALOG+ from a clinical setting to an educational setting using stakeholders' (teachers'and students') perspectives. We aim to evaluate the feasibility, acceptability, and estimated effect of implementing this intervention as a tool for the identification and mobilization of personal and social resources to mitigate the impact of social difficulties and to promote mental well-being. Methods: We will conduct an exploratory mixed methods study in public schools of postconflict areas in Tolima, Colombia. The study consists of 3 phases: adaptation, exploration, and consolidation of the DIALOG+ tool. The adaptation phase will identify possible changes that the intervention requires on the basis of data from focus groups with teachers and students. The exploration phase will be an exploratory cluster randomized trial with teachers and school counselors to assess the acceptability, feasibility, and estimated effect of DIALOG+ for adolescents in school settings. Adolescents' data about mental health symptoms and wellness will be collected before and after DIALOG+ implementation. During this phase, teachers or counselors who were part of the intervention group will share their opinions through the think-aloud method. Lastly, the consolidation phase will consist of 2 focus groups with teachers and students to discuss their experiences and to understand acceptability. Results: Study recruitment was completed in March 2022, and follow-up is anticipated to last through November 2022. Conclusions: This exploratory study will evaluate the acceptability, feasibility, and estimated effect of DIALOG+ for adolescents in postconflict school settings in Colombia. The use of this technology-supported tool aims to support interactions between teachers or counselors and students and to provide an effective student-centered communication guide. This is an innovative approach in both the school and the postconflict contexts that could help improve the mental health and wellness of adolescents in vulnerable zones in Colombia. Subsequent studies will be needed to evaluate the effectiveness of DIALOG+ in an educational context as a viable option to reduce the gap and inequities of mental health care access. [ABSTRACT FROM AUTHOR]

Background: Power wheelchairs can empower children with physical limitations to gain independence in their everyday lives; however, traditional methods of power wheelchair training are often limited by poor accessibility and safety concerns. Immersive virtual reality technology (IVRT) uses advanced display technology to place users in a fully immersive web-based environment that can support real-time skills training, often requiring less resources and fewer safety concerns than real-world methods. IVRT interventions have shown to be a feasible training option among adult power wheelchair users; however, there is still a need to understand the technical and clinical feasibility of developing an IVRT power wheelchair training tool for the pediatric population. Objective: This proposed study aims to use expert feedback and an iterative design process to develop an IVRT training intervention for pediatric power wheelchair skill development. Methods: This 3-phase feasibility study will be conducted within the assistive technology unit of a public pediatric hospital. Separate participant groups will be recruited for each phase, consisting of approximately 10 to 15 clinicians (phase 1), 10 pediatric power wheelchair users (phase 2), and 15 to 20 additional pediatric power wheelchair users (phase 3). Phase 1 will be conducted to gather feedback on the baseline IVRT training intervention. Clinicians will test the intervention and assess its usability and acceptability using qualitative and quantitative methods. Phase 1 participants will also be invited back for a subsequent session to reassess a revised version of the training intervention that has been updated based on their previous feedback. Phase 2 and phase 3 will also use mixed methods to gather feedback on the usability, acceptability, and user experience of the IVRT training intervention from current pediatric power wheelchair users. In addition, phase 3 participants will perform a skills transfer assessment to compare power mobility skill performance between the virtual reality and real-life environments. Data gathered in phase 2 will be used to further refine the IVRT intervention, whereas phase 3 data will be used to statistically evaluate the final version. Results: This study was approved by the Izaak Walton Killam Health Centre research ethics board in August 2021. Phase 1 testing began in February 2022. The entire study is expected to be completed by 2023. Conclusions: The results of this study will be used to create an IVRT training intervention for pediatric power wheelchair skill development through an iterative and collaborative design process. Results may also assist in directing future studies in this area. [ABSTRACT FROM AUTHOR]

Background: Resuming work after stroke is a common goal of working-age adults, yet there are few vocational rehabilitation programs designed to address the unique challenges faced following stroke. The Work intervention was developed to address these gaps. Objective: This paper presents a protocol that outlines the steps that will be undertaken to pilot both the intervention and trial processes for the Work trial. Methods: The Work trial is a 2-arm, prospective, randomized, blinded-assessor study with intention-to-treat analysis. A total of 54 adults of working age who have experienced a stroke <4 months prior will be randomized 1:1 to either (1) an experimental group who will receive a 12-week early vocational intervention (Work intervention) plus usual clinical rehabilitation or (2) a control group who will receive only their usual clinical rehabilitation. Results: Outcomes include study and intervention feasibility and intervention benefit. In addition to evaluating the feasibility of delivering vocational intervention early after stroke, benefit will be assessed by measuring rates of vocational participation and quality-of-life improvements at the 3- and 6-month follow-ups. Process evaluation using data collected during the study, as well as postintervention individual interviews with participants and surveys with trial therapists, will complement quantitative data. Conclusions: The results of the trial will provide details on the feasibility of delivering the Work intervention embedded within the clinical rehabilitation context and inform future trial processes. Pilot data will enable a future definitive trial to determine the clinical effectiveness of vocational rehabilitation when delivered in the early subacute phase of stroke recovery. [ABSTRACT FROM AUTHOR]

Background: Physical activity levels after bariatric surgery are usually low, despite the significant protective health benefits of physical activity in this population. Positive psychological well-being is associated with improved adherence to health behaviors, but bariatric surgery patients often have negative associations with physical activity that prevent sustained engagement. Objective: The Gaining Optimism After weight Loss Surgery (GOALS) pilot randomized controlled trial is aimed at testing a novel intervention to increase physical activity after bariatric surgery, which incorporates positive psychological skill-building with motivational interviewing and goal-setting. Methods: The GOALS trial is a 2-arm, 24-week pilot randomized controlled trial that aims to enroll 58 adults who report less than 200 minutes per week of moderate to vigorous physical activity and a desire to become more active 6-12 months after bariatric surgery. GOALS is testing the feasibility, acceptability, and preliminary efficacy of a positive psychology-motivational interviewing telephone intervention targeting to increase physical activity and associated positive affect. Intervention components include positive psychology, goal-setting, self-monitoring via provided Fitbits, and motivational interviewing to overcome barriers and increase motivation. The intervention is compared to a physical activity education control that includes mailings with psychoeducation around physical activity and provision of a Fitbit. The primary outcomes of the pilot trial are feasibility and acceptability, measured as session completion rates and participant ratings of ease and helpfulness of each session. The main secondary outcome is change in accelerometer-measured moderate to vigorous physical activity post intervention and at 24-week follow-up. Additional outcomes include changes in attitudes related to physical activity, psychological well-being, and physical health measures. Results: This multiphase project was funded in 2020 and institutional review board approval was obtained for the proposed trial in 2021. Recruitment for the randomized controlled trial began in July 2022. Upon completion of the pilot trial, we will examine the feasibility, acceptability, and preliminary efficacy of the intervention. Conclusions: Although bariatric surgery is the most effective treatment available for severe obesity, weight regain occurs, often in the context of low psychological well-being. Many individuals would benefit from learning strategies to increase positive psychological well-being after bariatric surgery, which could help them maintain lifestyle changes. Positive psychology is a novel approach to improve adherence by increasing positive associations with health behaviors including physical activity. The GOALS pilot trial will determine whether this type of intervention is feasible and acceptable to this population and will provide a foundation for a future full-scale randomized controlled efficacy trial. [ABSTRACT FROM AUTHOR]

Background: Chronic pain and access to care are identified as critical needs of the Veterans Health Administration. Music imagery and music listening interventions have shown promise as effective nonpharmacological options for pain management. However, most studies have focused on acute pain, passive music experiences, and in-person delivery. Objective: In this study, we aimed to examine the feasibility and acceptability of 2 music interventions delivered through telehealth for chronic musculoskeletal pain, trial design, and theoretical model before conducting a fully powered efficacy or comparative effectiveness trial. Methods: FAMILIA (Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia) is a 3-arm, parallel group, pilot trial. A total of 60 veterans will be randomized to one of the three conditions: music imagery, music listening, or usual care. Aim 1 is to test the feasibility and acceptability of a multicomponent, interactive music imagery intervention (8-weekly, individual sessions) and a single-component, minimally interactive music learning intervention (independent music listening). Feasibility metrics related to recruitment, retention, engagement, and completion of the treatment protocol and questionnaires will be assessed. Up to 20 qualitative interviews will be conducted to assess veteran experiences with both interventions, including perceived benefits, acceptability, barriers, and facilitators. Interview transcripts will be coded and analyzed for emergent themes. Aim 2 is to explore the effects of music imagery and music listening versus usual care on pain and associated patient-centered outcomes. These outcomes and potential mediators will be explored through changes from baseline to follow-up assessments at 1, 3, and 4 months. Descriptive statistics will be used to describe outcomes; this pilot study is not powered to detect differences in outcomes. Results: Recruitment for FAMILIA began in March 2022, and as of July 2022, 16 participants have been enrolled. We anticipate that enrollment will be completed by May 2023. We expect that music imagery and music listening will prove acceptable to veterans and that feasibility benchmarks will be reached. We hypothesize that music imagery and music listening will be more effective than usual care on pain and related outcomes. Conclusions: FAMILIA addresses four limitations in music intervention research for chronic pain: limited studies in veterans, evaluation of a multicomponent music intervention, methodological rigor, and internet-based delivery. Findings from FAMILIA will inform a fully powered trial to identify putative mechanisms and test efficacy. [ABSTRACT FROM AUTHOR]

Background: Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections in areas where the malaria burden is high and transmission occurs mainly during the rainy season. In Africa, so far, SMC has been implemented in the Sahel region. Mozambique contributes 4% of the global malaria cases, and malaria is responsible for one-quarter of all deaths in the country. Based on recommendations in the Malaria Strategic Plan, the Malaria Consortium, in partnership with the National Malaria Control Programme in Mozambique, initiated a phased SMC implementation study in the northern province of Nampula. The first phase of this 2-year implementation study was conducted in 2020-2021 and focused on the feasibility and acceptability of SMC. The second phase will focus on demonstrating impact. This paper describes phase 2 of the implementation study. Objective: Specific objectives include the following: (1) to determine the effectiveness of SMC in terms of its reduction in incidence of malaria infection among children aged 3 to 59 months; (2) to determine the chemoprevention efficacy of sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) when used for SMC in Nampula Province, Mozambique, and the extent to which efficacy is impacted by drug resistance and drug concentrations; (3) to investigate the presence and change in SP+AQ- and piperaquine-resistance markers over time as a result of SMC implementation; and (4) to understand the impact of the SMC implementation model, determining the process and acceptability outcomes for the intervention. Methods: This type 2, hybrid, effectiveness-implementation study uses a convergent mixed methods approach. SMC will be implemented in four monthly cycles between December 2021 and March 2022 in four districts of Nampula Province. Phase 2 will include four components: (1) a cluster randomized controlled trial to establish confirmed malaria cases, (2) a prospective cohort to determine the chemoprevention efficacy of the antimalarials used for SMC and whether drug concentrations or resistance influence the duration of protection, (3) a resistance marker study in children aged 3 to 59 months to describe changes in resistance marker prevalence over time, and (4) a process evaluation to determine feasibility and acceptability of SMC. Results: Data collection began in mid-January 2022, and data analysis is expected to be completed by October 2022. Conclusions: This is the first effectiveness trial of SMC implemented in Mozambique. The findings from this trial will be crucial to policy change and program expansion to other suitable geographies outside of the Sahel. The chemoprevention efficacy cohort study is a unique opportunity to better understand SMC drug efficacy in this new SMC environment. [ABSTRACT FROM AUTHOR]

Background: Digital mental health tools, designed to augment traditional mental health treatments, are becoming increasingly important due to a wide range of barriers to accessing mental health care, including a growing shortage of clinicians. Most existing tools use rule-based algorithms, often leading to interactions that feel unnatural compared with human therapists. Large language models (LLMs) offer a solution for the development of more natural, engaging digital tools. In this paper, we detail the development of Socrates 2.0, which was designed to engage users in Socratic dialogue surrounding unrealistic or unhelpful beliefs, a core technique in cognitive behavioral therapies. The multiagent LLM-based tool features an artificial intelligence (AI) therapist, Socrates, which receives automated feedback from an AI supervisor and an AI rater. The combination of multiple agents appeared to help address common LLM issues such as looping, and it improved the overall dialogue experience. Initial user feedback from individuals with lived experiences of mental health problems as well as cognitive behavioral therapists has been positive. Moreover, tests in approximately 500 scenarios showed that Socrates 2.0 engaged in harmful responses in under 1% of cases, with the AI supervisor promptly correcting the dialogue each time. However, formal feasibility studies with potential end users are needed., Objective: This mixed methods study examines the feasibility of Socrates 2.0., Methods: On the basis of the initial data, we devised a formal feasibility study of Socrates 2.0 to gather qualitative and quantitative data about users' and clinicians' experience of interacting with the tool. Using a mixed method approach, the goal is to gather feasibility and acceptability data from 100 users and 50 clinicians to inform the eventual implementation of generative AI tools, such as Socrates 2.0, in mental health treatment. We designed this study to better understand how users and clinicians interact with the tool, including the frequency, length, and time of interactions, users' satisfaction with the tool overall, quality of each dialogue and individual responses, as well as ways in which the tool should be improved before it is used in efficacy trials. Descriptive and inferential analyses will be performed on data from validated usability measures. Thematic analysis will be performed on the qualitative data., Results: Recruitment will begin in February 2024 and is expected to conclude by February 2025. As of September 25, 2024, overall, 55 participants have been recruited., Conclusions: The development of Socrates 2.0 and the outlined feasibility study are important first steps in applying generative AI to mental health treatment delivery and lay the foundation for formal feasibility studies., International Registered Report Identifier (irrid): DERR1-10.2196/58195., (©Philip Held, Sarah A Pridgen, Yaozhong Chen, Zuhaib Akhtar, Darpan Amin, Sean Pohorence. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 10.10.2024.)

Background: The war in Syria has displaced over 6.8 million people, more than any other conflict since the Second World War. As a result, Syrian asylum seekers and refugees have experienced several life-changing events, resulting in high rates of anxiety, depression, posttraumatic stress disorder, and suicidal ideation (SI). To address the treatment gap and reduce the burden of help-seeking, a web-based intervention to reduce SI developed for general populations was culturally adapted for and with Syrian asylum seekers and refugees in the United Kingdom. The study revealed the importance of understanding their lived experience with migration and the acculturative process in providing treatment for SI. This study will now assess the feasibility and acceptability of the culturally adapted intervention for this population., Objective: The first phase of the study will include recruiting participants and delivering the web-based intervention (1) to assess the feasibility of meeting recruitment goals and recruitment rates and (2) to assess the feasibility of outcome measures. The second phase of the study will include one-to-one semistructured interviews (1) to assess the suitability of the culturally adapted intervention in terms of recruitment and adherence rates and barriers and facilitators to engagement and (2) to assess the acceptability of the intervention in terms of its cultural relevance and appropriateness., Methods: This is a protocol for a single-group, noncontrolled, mixed methods feasibility and acceptability study of a culturally adapted web-based intervention to reduce SI for Syrian asylum seekers and refugees in the United Kingdom. The study will assess the feasibility of recruitment goals, recruitment rates, adherence rates, and outcome measures using individual participant tracking forms, which will be analyzed quantitatively. The suitability and acceptability of the intervention will be assessed using one-to-one semistructured interviews with 12 participants who completed the intervention, which will be analyzed qualitatively., Results: Recruitment began in February 2024 and will run until 30 participants are recruited to the study or until the end of July 2024. Thus far, 19 participants have provided informed consent, 16 were eligible and enrolled, and 12 have completed a postintervention interview. No data have been analyzed. The study, including the write-up period, is expected to end in December 2024., Conclusions: Despite experiencing several stressors related to forced displacement and high rates of mental health issues, access to treatment is still limited for Syrian asylum seekers and refugees in the United Kingdom. To address the treatment gap and reduce the burden of help-seeking, a web-based intervention to reduce SI was culturally adapted in collaboration with Syrian asylum seekers and refugees in the United Kingdom. This study will now assess the feasibility and acceptability of the intervention and culturally appropriate recruitment strategies., Trial Registration: ISRCTN ISRCTN11417025; https://www.isrctn.com/ISRCTN11417025., International Registered Report Identifier (irrid): PRR1-10.2196/56957., (©Oliver Beuthin, Sadiya Shahid, Ly-Mee Yu, Kamaldeep Bhui. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 02.09.2024.)

Background: In the United States, poor adherence accounts for up to 70% of all medication-related hospital admissions, resulting in $100 billion in health care costs annually. In pediatrics, adherence is largely dependent on caregivers. In a high-risk hematopoietic stem cell transplant (HSCT) population, caregivers are isolated with their child due to infection risk and must manage challenging treatment regimens at home, often with limited time and support. Complex behavioral interventions, typically employed to address adherence, are difficult to deliver and manage in the context of these daily tasks. The most successful adherence interventions, and thus improved clinical outcomes, have included mobile health (mHealth) reminder approaches and a direct measure of adherence. Objective: This is a 3-phase project, with this protocol describing phase 2, to determine the usability and feasibility of an mHealth app (BMT4me) designed to promote adherence to immunosuppressant medication and to track symptoms among children who received HSCT. Methods: This study uses an iterative convergent mixed methods design to develop and assess the usability and feasibility of an adherence digital health intervention. We will recruit 15 caregivers of pediatric patients receiving HSCT to complete user testing. Qualitative and quantitative data will be integrated to enhance and expand upon study findings. Results: Enrollment began in September 2021 and is ongoing. A total of 7 caregivers have enrolled. We anticipate completion by fall 2022. We anticipate high usability scores and a better understanding of unique features within the app that are needed for HSCT families post transplant. To date, usability scores among enrolled participants are greater than 70%. Feedback from qualitative interviews is being used to further adapt the app by adding specific weekly logs, call provider options, and voice to text. Conclusions: This protocol describes a mixed methods usability and feasibility study to develop and implement a smartphone app for caregivers of children receiving HSCT. The app was designed to improve immunosuppressant adherence and to track symptoms in the acute phase post discharge. Study findings will inform further refinement of the app and the feasibility of a pilot randomized controlled trial examining efficacy on clinical outcomes. [ABSTRACT FROM AUTHOR]

Background: Despite the proven benefits of exercise in older adults, challenges such as access and motivation can deter their engagement. Interactive virtual reality (VR) games combined with exercise (exergames) are a plausible strategy to encourage physical activity among this population. However, there has been little research on the feasibility, acceptability, and potential benefits of deploying at-home VR exergames among community-dwelling older adults. Objective: The objectives of this study are to estimate the feasibility, usability, and acceptability of a co-designed VR exergame in community-dwelling older adults; examine intervention feasibility and assessment protocols for a future large-scale trial; and provide pilot data on outcomes of interest (physical activity, exercise self-efficacy, mood, cognition, perception, and gameplay metrics). Methods: The study will be a remote, 6-week intervention comprising an experimental and a control group. A sample of at least 12 community-dwelling older adults (with no or mild cognitive impairment) will be recruited for each group. Both groups will follow the same study procedures and assessment methods. However, the experimental group will engage with a co-designed VR exergame (Seas The Day) thrice weekly for approximately 20 minutes using the Oculus Quest 2 (Facebook Reality Labs) VR headset. The control group will read (instead of playing Seas The Day) thrice weekly for approximately 20 minutes over the 6-week period. A mixed methods evaluation will be used. Changes in physical activity, exercise self-efficacy, mood, cognition, and perception will be compared before and after acute data as well as before and after the 6 weeks between the experimental (exergaming) and control (reading) groups. Qualitative data from postintervention focus groups or interviews and informal notes and reports from all participants will be analyzed to assess the feasibility of the study protocol. Qualitative data from the experimental group will also be analyzed to assess the feasibility, usability, and acceptability of at-home VR exergames and explore perceived facilitators of and barriers to uptaking VR systems among community-dwelling older adults. Results: The screening and recruitment process for the experimental group started in May 2021, and the data collection process will be completed by September 2021. The timeline of the recruitment process for the control group is September 2021 to December 2021. We anticipate an estimated adherence rate of =80%. Challenges associated with VR technology and the complexity of remote assessments are expected. Conclusions: This pilot study will provide important information on the feasibility, acceptability, and usability of a custom-made VR exergaming intervention to promote older adults' well-being. Findings from this study will be useful to inform the methodology, design, study procedures, and assessment protocol for future large-scale trials of VR exergames with older adults as well as deepen the understanding of remote deployment and at-home use of VR for exercise in older adults. [ABSTRACT FROM AUTHOR]

Background: Dental caries has significant public health implications afflicting young children. In addition to low social economic status, the most prominent risk factor for early childhood caries is sugar in the diet, particularly sugar-sweetened beverages. Dental treatment for caries in young children is commonly performed under general anesthesia and a significant proportion of children require repeated treatment. Interventions to reduce sugar-sweetened beverage consumption could lead to reduced rates of retreatment for dental caries in young children. Objective: This protocol describes the rationale, design, and methods of the “Thirsty for a Smile” feasibility study. The aim of the study is to assess the feasibility, acceptability, and appropriateness of a dietary intervention promoting water consumption in lieu of sugar-sweetened beverages among young patients, mostly from Latino heritage. Methods: This protocol describes a single-arm feasibility study. Twenty-one dyads of children and their caregivers will be recruited. Children between 2 and 9 years old who recently had treatment under general anesthesia for early childhood dental caries will be eligible to participate. The intervention has two components: (1) environmental, in which bottled water is delivered to participants’ homes; and (2) behavioral, in which caregivers will receive patient-centered counseling to increase children’s water intake and reduce sugar-sweetened beverages consumption. Dental caries and anthropometric data will be collected at examination during baseline and final visits. The primary outcome is feasibility and secondary outcomes are acceptability and appropriateness of the intervention. Results: Funding has been obtained from the National Institute of Dental and Craniofacial Research and the University of Washington approved the study. The feasibility study was conducted from March to November 2019. Conclusions: This feasibility study will test the study processes prior to a two-arm randomized controlled trial to determine feasibility and acceptability of the intervention and study procedures. This study may provide useful information for other researchers attempting to test similar interventions. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation (AF) is common in older people and increases the risk of stroke. The feasibility and effectiveness of the implementation of a patient-led AF screening program for older people are unknown. Objective: This study aims to examine the feasibility and effectiveness of an AF screening program comprising patient-led monitoring of single-lead electrocardiograms (ECGs) with clinician-coordinated central monitoring to diagnose AF among community-dwelling people aged ≥75 years in Australia. Methods: This is a nationwide randomized controlled implementation trial conducted via the internet and remotely among 200 community-dwelling adults aged ≥75 years with no known AF. Randomization will be performed in a 1:1 allocation ratio for the intervention versus control. Intervention group participants will be enrolled in the monitoring program at randomization. They will receive a handheld single-lead ECG device and training on the self-recording of ECGs on weekdays and submit their ECGs via their smartphones. The control group participants will receive usual care from their general practitioners for the initial 6 months and then commence the 6-month monitoring program. The ECGs will be reviewed centrally by trained personnel. Participants and their general practitioners will be notified of AF and other clinically significant ECG abnormalities. Results: This study will establish the feasibility and effectiveness of implementing the intervention in this patient population. The primary clinical outcome is the AF detection rate, and the primary feasibility outcome is the patient satisfaction score. Other outcomes include appropriate use of anticoagulant therapy, participant recruitment rate, program engagement (eg, frequency of ECG transmission), agreement in ECG interpretation between the device automatic algorithm and clinicians, the proportion of participants who complete the trial and number of dropouts, and the impact of frailty on feasibility and outcomes. We will conduct a qualitative evaluation to examine the barriers to and acceptability and enablers of implementation. Ethics approval was obtained from the human research ethics committee at the University of Sydney (project number 2020/680). The results will be disseminated via conventional scientific forums, including peer-reviewed publications and presentations at national and international conferences. Conclusions: By incorporating an integrated health care approach involving patient empowerment, centralized clinician-coordinated ECG monitoring, and facilitation of primary care and specialist services, it is possible to diagnose and treat AF early to reduce stroke risk. This study will provide new information on how to implement AF screening using digital health technology practicably and feasibly for older and frail populations residing in the community. [ABSTRACT FROM AUTHOR]

Background: Surgical site infections (SSIs) are the most common nosocomial infection and occur in 16.3% of patients undergoing colorectal surgery at our institution (The Ottawa Hospital), the majority of which are identified after discharge from hospital. Patients who suspect having an SSI generally present to the emergency department or surgery clinic. Both options for in-person interaction are costly to the health care system and patients. A mobile app, how2trak, has proven to be beneficial for patients with complex wounds at our institution by facilitating at-home monitoring and virtual consultations. Objective: This study aims to assess the feasibility of a randomized controlled trial to assess if how2trak can improve patients' experience and increase detection of SSIs after colorectal surgery while reducing patients' risk of COVID-19 exposure. Methods: In this single-center prospective feasibility trial, eligible patients undergoing colorectal surgery will be randomized to either standard care or how2trak postoperative monitoring of their incision, symptoms, and ostomy function. Patient self-assessments will be monitored by a nurse specialized in wound and ostomy care who will follow-up with patients with a suspected SSI. The primary outcome is feasibility as measured by enrollment, randomization, app usability, data extraction, and resource capacity. Results: This study was approved by our institution's ethics board on February 26, 2021, and received support from The Ottawa Hospital Innovation and Care Funding on November 12, 2021. Recruitment started June 3, 2021, and 29 were patients enrolled as of September 2021. We expect to publish results in spring 2022. Conclusions: This study will determine the feasibility of using a mobile app to monitor patients'wounds and detect SSIs after colorectal surgery. If feasible, we plan to assess if this mobile app facilitates SSI detection, enhances patient experience, and optimizes their care. [ABSTRACT FROM AUTHOR]

Background: The ubiquity of mobile phones and increasing use of wearable fitness trackers offer a wide-ranging window into people’s health and well-being. There are clear advantages in using remote monitoring technologies to gain an insight into health, particularly under the shadow of the COVID-19 pandemic. Objective: Covid Collab is a crowdsourced study that was set up to investigate the feasibility of identifying, monitoring, and understanding the stratification of SARS-CoV-2 infection and recovery through remote monitoring technologies. Additionally, we will assess the impacts of the COVID-19 pandemic and associated social measures on people’s behavior, physical health, and mental well-being. Methods: Participants will remotely enroll in the study through the Mass Science app to donate historic and prospective mobile phone data, fitness tracking wearable data, and regular COVID-19–related and mental health–related survey data. The data collection period will cover a continuous period (ie, both before and after any reported infections), so that comparisons to a participant’s own baseline can be made. We plan to carry out analyses in several areas, which will cover symptomatology; risk factors; the machine learning–based classification of illness; and trajectories of recovery, mental well-being, and activity. Results: As of June 2021, there are over 17,000 participants—largely from the United Kingdom—and enrollment is ongoing. Conclusions: This paper introduces a crowdsourced study that will include remotely enrolled participants to record mobile health data throughout the COVID-19 pandemic. The data collected may help researchers investigate a variety of areas, including COVID-19 progression; mental well-being during the pandemic; and the adherence of remote, digitally enrolled participants. [ABSTRACT FROM AUTHOR]

Background: There is a dearth of specialized mental health workforce in low- and middle-income countries. Use of mobile technology by frontline community health workers (CHWs) is gaining momentum in Pakistan and needs to be explored as an alternate strategy to improve mental well-being., Objective: The aim of this study is to assess the feasibility, acceptability, and usefulness of an app-based counseling intervention delivered by government lady health workers (LHWs) to reduce anxiety and depression in rural Pakistan., Methods: Project mPareshan is a single-arm, pre- and posttest implementation research trial in Badin District, Sindh, using mixed methods of data collection executed in 3 phases (preintervention, intervention, and postintervention). In the preintervention phase, formative qualitative assessments through focus group discussions and in-depth interviews assess the acceptability and appropriateness of intervention through perceptions of all concerned stakeholders using a specific interview guide. A REDCap (Research Electronic Data Capture)-based baseline survey using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 Scale (GAD-7) determines the point prevalence of depression and anxiety among consenting men and women older than 18 years. Individuals with mild and moderate anxiety and depression are identified as screen positives (SPs) and are eligible for mPareshan app-based intervention. Mental health literacy of health workers is improved through customized training adapting the World Health Organization's Mental Health Gap Action Programme guide 2.0. The intervention (mPareshan app) consists of tracking, counseling, and referral segments. The tracking segment facilitates participant consent and enrollment while the referral segment is used by LHWs to transfer severe cases to the next level of specialist care. Through the counseling segment, identified SPs are engaged during LHWs' routine home visits in 6 face-to-face 20-minute counseling sessions over 6 months. Each session imparts psychoeducation through audiovisual aids, breathing exercises, and coping skills to reduce stress. Clinical and implementation outcomes include change in mean anxiety and depression scores and identification of facilitators and barriers in intervention uptake and rollout., Results: At the time of this submission (April 2024), we are analyzing the results of 366 individuals who participated in the baseline prevalence survey, the change in knowledge and skills of 72 health workers who took the mPareshan training, change in anxiety and depression scores of 98 SPs recruited for app-based counseling intervention, and perceptions of stakeholders pre- and postintervention gathered through 8 focus group discussions and 18 in-depth interviews., Conclusions: This trial will assess the feasibility of early home-based mental health screening, counseling, and prompt referrals by frontline health workers to reduce anxiety and depression in the community. The study findings will set the stage for integrating mental health into primary health care., Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12622000989741; https://tinyurl.com/5n844c8z., International Registered Report Identifier (irrid): DERR1-10.2196/54272., (©Fauziah Rabbani, Javeria Nafis, Samina Akhtar, Muhammad Shahid Khan, Saleem Sayani, Amna Siddiqui, Sameen Siddiqi, Zul Merali. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.07.2024.)

Background: Tooth extraction procedures often lead to bone resorption, which can have adverse effects on the dimensions of the alveolar ridge. Research has shown that socket preservation techniques using bone graft substitutes can effectively minimize early bone loss in such cases. α-calcium sulfate hemihydrate (α-CSH) has garnered significant attention as a potential bone graft material due to its favorable properties, including osteoconductivity, angiogenic potential, and biocompatibility. Considering these facts, we developed a preliminary protocol for applying α-CSH in addressing alveolar bone loss following tooth extraction., Objective: This research's general objective is to evaluate the feasibility and initial effectiveness of α-CSH as bone-inducing graft material for socket preservation after tooth extraction., Methods: This preliminary clinical trial will involve 30 fresh extraction sockets from individuals aged 18-35 years. The participants will be divided into 2 groups: one group will receive α-CSH graft material after tooth extraction for socket preservation, while the other group will not receive any graft material. Throughout the study, the participants will be closely monitored for safety measures, which will include clinical examinations, radiographic imaging, and blood tests. Radiographic imaging will be used extensively to assist the progress of bone formation., Results: The study commenced enrollment in August 2022 and is scheduled to conclude post assessments and analyses by the end of 2023. The results of the study are anticipated to be accessible in late 2024., Conclusions: This clinical study represents the initial investigation in humans to assess the feasibility and efficacy of α-CSH in alveolar bone regeneration. We hypothesize that the inclusion of α-CSH can greatly expedite the process of bone formation within fresh sockets, resulting in a swift restoration of bone height without the disadvantages associated with harvesting autogenous bone graft., Trial Registration: Indonesia Registry Center INA-D02FAHP; https://tinyurl.com/2jnf6n3s., International Registered Report Identifier (irrid): DERR1-10.2196/49922., (©Muhammad Ruslin, Nurlindah Hamrun, Andi Tajrin, Andi Sitti Hajrah Yusuf, Rifaat Nurrahma, Diandra Sabrina Natsir-Kalla, Yossy Yoanita Ariestiana, Mukhtar Nur Anam, Chung-Ming Liu, Keng-Liang Ou. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 19.07.2024.)

Background: High-risk alcohol consumption among young adults frequently occurs in the presence of peers who are also drinking. A high-risk drinking situation may consist of particular social network members who have a primary association with drinking. Fine-grained approaches such as ecological momentary assessment (EMA) are growing in popularity for studying real-time social influence, but studies using these approaches exclusively rely on participant self-report. Passive indicators of peer presence using Bluetooth-based technology to detect real-time interactions have the potential to assist in the development of just-in-time interventions., Objective: This study seeks to examine the feasibility and acceptability of using a Bluetooth-based sensor and smartphone app to measure social contact in real-world drinking situations., Methods: Young adults (N=20) who drink heavily and report social drinking will be recruited from the community to participate in a 3-week EMA study. Using a social network interview, index participants will identify and recruit 3 of their friends to carry a Bluetooth beacon. Participants will complete a series of EMA reports on their own personal Android devices including random reports; morning reports; first-drink reports; and signal-contingent reports, which are triggered following the detection of a beacon carried by a peer participant. EMA will assess alcohol use and characteristics of the social environment, including who is nearby and who is drinking. For items about peer proximity and peer drinking, a customized peer list will be presented to participants. Feedback about the study protocol will be ascertained through weekly contact with both index and peer participants, followed by a qualitative interview at the end of the study. We will examine the feasibility and acceptability of recruitment, enrollment of participants and peers, and retention. Feasibility will be determined using indexes of eligibility, enrollment, and recruitment. Acceptability will be determined through participant enrollment and retention, protocol compliance, and participant-reported measures of acceptability. Feasibility and acceptability for peer participants will be informed by enrollment rates, latency to enrollment, compliance with carrying the beacon, and self-reported reasons for compliance or noncompliance with beacon procedures. Finally, EMA data about peer proximity and peer drinking will support the validity of the peer selection process., Results: Participant recruitment began in February 2023, and enrollment was completed in December 2023. Results will be reported in 2025., Conclusions: The protocol allows us to examine the feasibility and acceptability of a Bluetooth-based sensor for the detection of social contact between index participants and their friends, including social interactions during real-world drinking situations. Data from this study will inform just-in-time adaptive interventions seeking to address drinking in the natural environment by providing personalized feedback about a high-risk social context and alerting an individual that they are in a potentially unsafe situation., International Registered Report Identifier (irrid): DERR1-10.2196/50650., (©Kristina Jackson, Matthew Meisel, Alexander Sokolovsky, Katie Chen, Nancy Barnett. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.06.2024.)

Background: The gender gap in time use and its impact on health and well-being are still prevalent. Women work longer hours than men when considering both paid and unpaid (eg, childcare and chores) work, and this gender disparity is particularly visible among parents. Less is known about factors that could potentially mediate or moderate this relationship (eg, work-family conflict and gender role beliefs). Ecological momentary assessment (EMA) allows for the documentation of changes in momentary internal states, such as time use, stress, or mood. It has shown particular validity to measure shorter-term activities (eg, unpaid work) and is thus useful to address gender differences., Objective: The feasibility of the daily EMA surveys in a parent sample will be examined. The associations between time use, well-being, and stress will be examined, along with potential moderating and mediating factors such as gender, gender role beliefs, and work-family conflict. Finally, the act of monitoring one's own time use, well-being, and stress will be examined in relation to, for example, the quality of life., Methods: We conducted a quasi-experimental, nonrandomized controlled trial with 3 data collection methods, namely, online questionnaires, EMA surveys, and qualitative interviews. The intervention group (n=64) will participate in the online questionnaires and EMA surveys, and a subsample of the intervention group (n=6-17) will also be invited to participate in qualitative interviews. Over a period of 1 week, participants in the intervention group will answer daily EMA surveys (4 times per day). In contrast, the control group (n=17) will only participate in the online questionnaires at baseline and after 1 week. The following constructs were surveyed: sociodemographic background (eg, age, gender, and household composition; baseline questionnaire); mediators and moderators (eg, gender role beliefs and work-family conflict; baseline and follow-up questionnaires); well-being, quality of life, and trait mindfulness (baseline and follow-up questionnaires); momentary activity and well-being, as well as state mindfulness (EMA); and feasibility (baseline and follow-up questionnaires as well as interviews). We anticipate that participants will regard the daily EMA as feasible. Particular daily time-use patterns (eg, high paid and unpaid workload) are expected to be related to lower well-being, higher stress, and health-related quality of life. These associations are expected to be moderated and mediated by factors such as gender, gender role beliefs, work-family conflict, and social support. Participants in the intervention group are expected to show higher values of mindfulness, well-being, health-related quality of life, and lower stress., Results: Patient recruitment started in November 2023 and ended in mid April 2024. Data analysis commenced in mid April 2024., Conclusions: This study aims to provide valuable insights into the feasibility of using EMAs and the potential benefits of activity tracking in various aspects of daily life., Trial Registration: Open Science Framework 8qj3d; https://osf.io/8qj3d., International Registered Report Identifier (irrid): PRR1-10.2196/54728., (©Laura Altweck, Silke Schmidt, Samuel Tomczyk. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 31.05.2024.)

Background: Single-lead, smartphone-based mobile electrocardiograms (ECGs) have the potential to provide a noninvasive, rapid, and cost-effective means of screening for atrial fibrillation (AFib) in outpatient settings. AFib has been associated with various comorbid diseases that prompt further investigation and screening methodologies for at-risk populations. A simple 30-second sinus rhythm strip from the KardiaMobile ECG (AliveCor) can provide an effective screen for cardiac rhythm abnormalities., Objective: The aim of this study is to demonstrate the feasibility of performing Kardia-enabled ECG recordings routinely in outpatient settings in high-risk populations and its potential use in uncovering previous undiagnosed cases of AFib. Specific aim 1 is to determine the feasibility and accuracy of performing routine cardiac rhythm sampling in patients deemed at high risk for AFib. Specific aim 2 is to determine whether routine rhythm sampling in outpatient clinics with high-risk patients can be used cost-effectively in an outpatient clinic without increasing the time it takes for the patient to be seen by a physician., Methods: Participants were recruited across 6 clinic sites across the University of Florida Health Network: University of Florida Health Nephrology, Sleep Center, Ophthalmology, Urology, Neurology, and Pre-Surgical. Participants, aged 18-99 years, who agreed to partake in the study were given a consent form and completed a questionnaire regarding their past medical history and risk factors for cardiovascular disease. Single-lead, 30-second ECGs were taken by the KardiaMobile ECG device. If patients are found to have newly diagnosed AFib, the attending physician is notified, and a 12-lead ECG or standard ECG equivalent will be ordered., Results: As of March 1, 2024, a total of 2339 participants have been enrolled. Of the data collected thus far, the KardiaMobile rhythm strip reported 381 abnormal readings, which are pending analysis from a cardiologist. A total of 78 readings were labeled as possible AFib, 159 readings were labeled unclassified, and 49 were unreadable. Of note, the average age of participants was 61 (SD 10.25) years, and the average self-reported weight was 194 (SD 14.26) pounds. Additionally, 1572 (67.25%) participants report not regularly seeing a cardiologist. Regarding feasibility, the average length of enrolling a patient into the study was 3:30 (SD 0.5) minutes after informed consent was completed, and medical staff across clinic sites (n=25) reported 9 of 10 level of satisfaction with the impact of the screening on clinic flow., Conclusions: Preliminary data show promise regarding the feasibility of using KardiaMobile ECGs for the screening of AFib and prevention of cardiological disease in vulnerable outpatient populations. The use of a single-lead mobile ECG strip can serve as a low-cost, effective AFib screen for implementation across free clinics attempting to provide increased health care accessibility., International Registered Report Identifier (irrid): DERR1-10.2196/52647., (©Ajay Mittal, Yasmine Elkaldi, Susana Shih, Riken Nathu, Mark Segal. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 27.05.2024.)

Background: While the scientific community widely recognizes the benefits of physical activity (PA) in oncology supportive care, cancer survivors who have undergone chemo- or radio-immunotherapy treatments struggle to meet PA recommendations. This underscores the importance of identifying factors influencing active lifestyle adoption and maintenance and proposing a multilevel model (micro-, meso-, and macrolevel) to better understand facilitators and barriers. Currently, no socioecological model explains an active lifestyle in the posttreatment phase of breast, colorectal, prostate, and lung cancers., Objective: The objective is to identify factors influencing an active lifestyle in cancer survivorship and assess the feasibility of an individualized program targeting an active lifestyle. The objectives will be addressed in 3 stages. Stage 1 aims to elucidate factors associated with the active lifestyle of cancer survivors. Stage 2 involves developing an explanatory model based on previously identified factors to create a tailored health education program for an active lifestyle after oncology treatments. Stage 3 aims to evaluate the feasibility and potential effects of this personalized health education program after its national implementation., Methods: First, the exploration of factors influencing PA (stage 1) will be based on a mixed methods approach, using an explanatory sequential design and multilevel analysis. The quantitative phase involves completing a questionnaire from a socioecological perspective. Subsequently, a subset of respondents will engage in semistructured interviews to aid in interpreting the quantitative results. This phase aims to construct a model of the factors influencing an active lifestyle and develop an individualized 12-week program based on our earlier findings (stage 2). In stage 3, we will implement our multicenter, multimodal program for 150 physically inactive and sedentary cancer survivors across metropolitan France. Program feasibility will be evaluated. Measured PA level by connected device and multidimensional variables such as declared PA and sedentary behaviors, PA readiness, motivation, PA preferences, PA knowledge and skills, and barriers and facilitators will be assessed before and during the program and 52 weeks afterward., Results: The institutional review board approved the mixed methods study (phase 1) in April 2020, and the intervention (phase 3) was approved in March 2022. Recruitment and data collection commenced in April 2022, with intervention implementation concluded in May 2023. Data collection and full analysis are expected to be finalized by July 2024., Conclusions: The Determinants and Factors of Physical Activity After Oncology Treatments (DEFACTO) study seeks to enhance our understanding, within our socioecological model, of factors influencing an active lifestyle among cancer survivors and to assess whether a tailored intervention based on this model can support an active lifestyle., Trial Registration: ClinicalTrials.gov NCT05354882; https://www.clinicaltrials.gov/study/NCT05354882., International Registered Report Identifier (irrid): DERR1-10.2196/52274., (©Albane Aumaitre, Rémi Gagnayre, Aude-Marie Foucaut. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.05.2024.)

Background: Post-COVID-19 syndrome (PCS; also known as "long COVID") is a relatively novel disease comprising physical, psychological, and cognitive complaints persisting several weeks to months after acute infection with SARS-CoV-2. Approximately 10% of patients with COVID-19 are affected by long-term symptoms. However, effective treatment strategies are lacking. The ErgoLoCo (Occupational Therapy [Ergotherapie] for Long COVID) study was designed to develop and evaluate a novel occupational therapy (OT) concept of online delivery of therapy for long COVID., Objective: The primary study objective is to assess the feasibility of the online OT intervention in PCS. Secondary aims include the evaluation of online OT concerning cognitive problems, occupational performance, and social participation., Methods: This randomized controlled interventional pilot study involves parallel mixed methods process analyses and a realist evaluation approach. A total of 80 clients with PCS aged at least 16 years will be recruited into two interventional groups. The control cohort (watch and wait) comprises 80 clients with long COVID. Treatment is provided through teletherapy (n=40) or delivery of prerecorded videos (n=40) using the same standardized OT concept twice weekly over 12 weeks. Analyses of quantitative questionnaires and qualitative interviews based on the theoretical framework of acceptability will be performed to assess feasibility. Focus group meetings will be used to assess how acceptable and helpful the intervention was to the participating occupational therapists. Standardized tests will be used to assess the initial efficacy of the intervention on neurocognitive performance; limitations in mobility, self-care, and everyday activities; pain; disabilities; quality of life (QoL); social participation; and anxiety and depression in PCS, and the possible effects of online OT on these complaints., Results: The German Ministry of Education and Research provided funding for this research in March 2022. Data collection took place from October 2022 to August 31, 2023. Data analysis will be completed by the end of April 2024. We anticipate publishing the results in the fall of 2024., Conclusions: Despite the enormous clinical need, effective and scalable treatment options for OT clients who have PCS remain scarce. The ErgoLoCo study will assess whether online-delivered OT is a feasible treatment approach in PCS. Furthermore, this study will assess the effect of the intervention on cognitive symptoms, QoL, and occupational performance and participation in everyday life. Particular emphasis will be placed on the experiences of clients and occupational therapists with digitally delivered OT. This study will pave the way for novel and effective treatment strategies in PCS., Trial Registration: German Clinical Trial Registry DRKS00029990; https://drks.de/search/de/trial/DRKS00029990., International Registered Report Identifier (irrid): PRR1-10.2196/50230., (©Christina Müllenmeister, Andrea Stoelting, Dominik Schröder, Tim Schmachtenberg, Simon Ritter, Iman El-Sayed, Sandra Steffens, Frank Klawonn, Sandra Klawitter, Stefanie Homann, Marie Mikuteit, Christoph Berg, Georg Behrens, Eva Hummers, Aisha Cook, Frank Müller, Alexandra Dopfer-Jablonka, Christine Happle. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.05.2024.)

Background: Within hospital systems, diverse subsets of patients are subject to minimally invasive procedures that provide therapeutic relief and necessary health data that are often perceived as anxiogenic or painful. These feelings are particularly relevant to patients experiencing procedures where they are conscious and not sedated or placed under general anesthesia that renders them incapacitated. Pharmacologic pain management and topical anesthetic creams are used to manage these feelings; however, distraction-based methods can provide nonpharmacologic means to modify the painful experience and discomfort often associated with these procedures. Recent studies support distraction as a useful method for reducing anxiety and pain and as a result, improving patient experience. Virtual reality (VR) is an emerging technology that provides an immersive user experience and can operate through a distraction-based method to reduce the negative or painful experience often related to procedures where the patient is conscious. Given the possible short-term and long-term outcomes of poorly managed pain and enduring among patients, health care professionals are challenged to improve patient well-being during medically essential procedures., Objective: The purpose of this pilot project is to assess the efficacy of using VR as a distraction-based intervention for anxiety or pain management compared to other nonpharmacologic interventions in a variety of hospital settings, specifically in patients undergoing lumbar puncture procedures and bone marrow biopsies at the oncology ward, patients receiving nerve block for a broken bone at an anesthesia or surgical center, patients undergoing a cleaning at a dental clinic, patients conscious during an ablation procedure at a cardiology clinic, and patients awake during a kidney biopsy at a nephrology clinic. This will provide the framework for additional studies in other health care settings., Methods: In a single visit, patients eligible for the study will complete brief preprocedural and postprocedural questionnaires about their perceived fear, anxiety, and pain levels. During the procedure, research assistants will place a VR headset on the patient and the patient will undergo a VR experience to distract from any pain felt from the procedure. Participants' vitals, including blood pressure, heart rate, and rate of respiration, will also be recorded before, during, and after the procedure., Results: The study is already underway, and results support a decrease in perceived pain by 1.00 and a decrease in perceived anxiety by 0.3 compared to the control group (on a 10-point Likert scale). Among the VR intervention group, the average rating for comfort was 4.35 out of 5., Conclusions: This study will provide greater insight into how patients' perception of anxiety and pain could potentially be altered. Furthermore, metrics related to the operational efficiency of providing a VR intervention compared to a control will provide insight into the feasibility and integration of such technologies in routine practice., International Registered Report Identifier (irrid): DERR1-10.2196/52649., (©Ajay Mittal, Jonathan Wakim, Suhaiba Huq, Tung Wynn. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.05.2024.)

Background: Digital health tools can support behavior change and allow interventions to be scalable at a minimal cost. Keep-on-Keep-up Nutrition (KOKU-Nut) is a free, tablet-based app that focuses on increasing physical activity and improving the dietary intake of older adults based on UK guidelines. The intervention targets an important research area identified as a research priority reported by the James Lind Alliance priority setting partnership for malnutrition., Objective: This study aims to assess the feasibility of using the digital health tool KOKU-Nut among community-dwelling older adults to inform a future randomized controlled trial. The secondary aims are to determine the acceptability, usability, preliminary effect sizes, and safety of the study and the intervention (KOKU-Nut)., Methods: This is a feasibility randomized controlled trial. We plan to recruit a total of 36 community-dwelling older adults using purposive sampling. Participants will be randomized 1:1 to either the intervention or the control group. The intervention group will be asked to engage with KOKU-Nut 3 times a week for 12 weeks. Participants in the control group will receive a leaflet promoting a healthy lifestyle. All study participants will complete questionnaires at baseline and the end of the 12 weeks. A sample of participants will be asked to participate in an optional interview. The study will collect a range of data including anthropometry (height and weight), dietary intake (3-day food diary), physical function (grip strength and 5-times sit-to-stand), perceived quality of life (EQ-5D), usability (System Usability Scale), and safety (adverse events)., Results: Data collection commenced in March 2024, and the results will be ready for publication by January 2025. Feasibility will be determined on the basis of participants' self-reported engagement with the intervention, and recruitment and retention rates and will be summarized descriptively. We will also consider the amount of missing data and assess how outcomes are related to group assignment. Acceptability will be measured using the modified treatment evaluation inventory and one-to-one semistructured interviews. Transcripts from the interviews will be analyzed using NVivo (version 12; QSR International) software using framework analysis to understand any barriers to the recruitment process, the suitability of the assessment measures, and the acceptability of the intervention and study design., Conclusions: The study aligns with guidelines developed by the Medical Research Council for developing a complex intervention by using qualitative and quantitative research to examine the barriers of the intervention and identify potential challenges around recruitment and retention. We anticipate that these results will inform the development of a future powered randomized controlled design trial to test the true effectiveness of KOKU-Nut., Trial Registration: ClinicalTrials.gov NCT05943366; https://classic.clinicaltrials.gov/ct2/show/NCT05943366., International Registered Report Identifier (irrid): PRR1-10.2196/50922., (©Chloe French, Sorrel Burden, Emma Stanmore. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.04.2024.)

Background: The United Nations' Sustainable Development Goal 4, and particularly target 4.2, which seeks to ensure that, by 2030, all children have access to quality early childhood development, care, and preprimary education so that they are ready for primary education, is far from being achieved. The COVID-19 pandemic compromised progress by disrupting education, reducing access to well-being resources, and increasing family violence. Evidence from low- and middle-income countries suggests that in-person parenting interventions are effective at improving child learning and preventing family violence. However, scaling up these programs is challenging because of resource constraints. Integrating digital and human-delivered intervention components is a potential solution to these challenges. There is a need to understand the feasibility and effectiveness of such interventions in low-resource settings., Objective: This study aims to determine the feasibility and effectiveness of a digital parenting program (called Naungan Kasih in Bahasa Melayu [Protection through Love]) delivered in Malaysia, with varying combinations of 2 components included to encourage engagement. The study is framed around the following objectives: (1) to determine the recruitment, retention, and engagement rates in each intervention condition; (2) to document implementation fidelity; (3) to explore program acceptability among key stakeholders; (4) to estimate intervention costs; and (5) to provide indications of the effectiveness of the 2 components., Methods: This 10-week factorial cluster randomized trial compares ParentText, a chatbot that delivers parenting and family violence prevention content to caregivers of preschool-aged children in combination with 2 engagement components: (1) a WhatsApp support group and (2) either 1 or 2 in-person sessions. The trial aims to recruit 160 primary and 160 secondary caregivers of children aged 4-6 years from 8 schools split equally across 2 locations: Kuala Lumpur and Negeri Sembilan. The primary outcomes concern the feasibility and acceptability of the intervention and its components, including recruitment, retention, and engagement. The effectiveness outcomes include caregiver parenting practices, mental health and relationship quality, and child development. The evaluation involves mixed methods: quantitative caregiver surveys, digitally tracked engagement data of caregivers' use of the digital intervention components, direct assessments of children, and focus group discussions with caregivers and key stakeholders., Results: Overall, 208 parents were recruited at baseline December 2023: 151 (72.6%) primary caregivers and 57 (27.4%) secondary caregivers. In January 2024, of these 208 parents, 168 (80.8%) enrolled in the program, which was completed in February. Postintervention data collection was completed in March 2024. Findings will be reported in the second half of 2024., Conclusions: This is the first factorial cluster randomized trial to assess the feasibility of a hybrid human-digital playful parenting program in Southeast Asia. The results will inform a large-scale optimization trial to establish the most effective, cost-effective, and scalable version of the intervention., Trial Registration: OSF Registries; https://osf.io/f32ky., International Registered Report Identifier (irrid): DERR1-10.2196/55491., (©Hal Cooper, Farah Zeehan Mohd Nadzri, Seema Vyas, Rumaya Juhari, Nellie Ismail, Zarinah Arshat, Durgesh Rajandiran, Laurie Markle, Francisco Calderon, Inge Vallance, G J Melendez-Torres, Chiara Facciolà, Vanisa Senesathith, Frances Gardner, Jamie M Lachman. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 26.04.2024.)

Background: Exercise rehabilitation is a promising strategy for reducing cardiovascular disease risk among patients with breast cancer. However, the evidence is primarily derived from programs based at exercise centers with in-person supervised delivery. Conversely, most patients report a preference for home-based rehabilitation. As such, there is a clear need to explore strategies that can provide real-time supervision and coaching while addressing consumer preferences. Evidence from cardiac rehabilitation has demonstrated the noninferiority of a smartphone-based telerehabilitation approach (REMOTE-CR) to improve cardiorespiratory fitness in people with cardiovascular disease compared to a center-based program., Objective: This study aims to assess the feasibility, safety, and preliminary efficacy of the REMOTE-CR program adapted for patients with breast cancer at risk of cardiotoxicity (REMOTE-COR-B). We will also assess the satisfaction and usability of REMOTE-COR-B., Methods: We will conduct a single-arm feasibility study of the REMOTE-COR-B program among patients with stage I-III breast cancer who are at risk of cardiotoxicity (taking treatment type and dose, as well as other common cardiovascular disease risk factors into account) and who are within 24 months of completing primary definitive treatment. Participants (target sample size of 40) will receive an 8-week smartphone-based telerehabilitation exercise program involving remotely delivered real-time supervision and behavior change support. The platform comprises a smartphone and wearable heart rate monitor, as well as a custom-built smartphone app and web application. Participants will be able to attend remotely monitored exercise sessions during set operating hours each week, scheduled in both the morning and evening. Adherence is the primary outcome of the trial, assessed through the number of remotely monitored exercise sessions attended compared to the trial target (ie, 3 sessions per week). Secondary outcomes include additional trial feasibility indicators (eg, recruitment and retention), safety, satisfaction, and usability, and objective and patient-reported efficacy outcomes (cardiovascular fitness, quality of life, fatigue, self-reported exercise, self-efficacy, habit strength, and motivation). Adherence, feasibility, and safety outcomes will be assessed during the intervention period; intervention satisfaction and usability will be assessed post intervention; and objective and patient-reported efficacy outcomes will be assessed at baseline, post intervention (2-month postbaseline assessment), and at follow-up (5-month postbaseline assessment)., Results: Recruitment for this trial commenced in March 2023, and 7 participants had been recruited as of the submission of the manuscript. The estimated completion date for the project is October 2024, with results expected to be published in mid-2025., Conclusions: The REMOTE-COR-B intervention is a novel and promising approach to providing exercise therapy to patients with breast cancer at risk of cardiotoxicity who have unique needs and heightened safety risks. This project will provide important information on the extent to which this approach is satisfactory to patients with breast cancer, safe, and potentially effective, which is necessary before larger-scale research or clinical projects., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621001557820; www.anzctr.org.au/ACTRN12621001557820.aspx., International Registered Report Identifier (irrid): DERR1-10.2196/53301., (©Camille E Short, Jonathan C Rawstorn, Tamara L Jones, Lara Edbrooke, Sandra C Hayes, Ralph Maddison, Sophie Nightingale, Hilmy Ismail, Richard De Boer, Fiona Hegi-Johnson, Aaron L Sverdlov, Robyn Bell, Irene Halligan, Linda Denehy. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 05.04.2024.)

Background: Sleep disturbances are a potentially modifiable risk factor for neurodegenerative dementia secondary to Alzheimer disease (AD) and Lewy body disease (LBD). Therefore, we need to identify the best methods to study sleep in this population., Objective: This study will assess the feasibility and acceptability of various wearable devices, smart devices, and remote study tasks in sleep and cognition research for people with AD and LBD., Methods: We will deliver a feasibility and acceptability study alongside a prospective observational cohort study assessing sleep and cognition longitudinally in the home environment. Adults aged older than 50 years who were diagnosed with mild to moderate dementia or mild cognitive impairment (MCI) due to probable AD or LBD and age-matched controls will be eligible. Exclusion criteria include lack of capacity to consent to research, other causes of MCI or dementia, and clinically significant sleep disorders. Participants will complete a cognitive assessment and questionnaires with a researcher and receive training and instructions for at-home study tasks across 8 weeks. At-home study tasks include remote sleep assessments using wearable devices (electroencephalography headband and actigraphy watch), app-based sleep diaries, online cognitive assessments, and saliva samples for melatonin- and cortisol-derived circadian markers. Feasibility outcomes will be assessed relating to recruitment and retention, data completeness, data quality, and support required. Feedback on acceptability and usability will be collected throughout the study period and end-of-study interviews will be analyzed using thematic analysis., Results: Recruitment started in February 2022. Data collection is ongoing, with final data expected in February 2024 and data analysis and publication of findings scheduled for the summer of 2024., Conclusions: This study will allow us to assess if remote testing using smart devices and wearable technology is a viable alternative to traditional sleep measurements, such as polysomnography and questionnaires, in older adults with and without MCI or dementia due to AD or LBD. Understanding participant experience and the barriers and facilitators to technology use for research purposes and remote research in this population will assist with the development of, recruitment to, and retention within future research projects studying sleep and cognition outside of the clinic or laboratory., International Registered Report Identifier (irrid): DERR1-10.2196/52652., (©Victoria Grace Gabb, Jonathan Blackman, Hamish Duncan Morrison, Bijetri Biswas, Haoxuan Li, Nicholas Turner, Georgina M Russell, Rosemary Greenwood, Amy Jolly, William Trender, Adam Hampshire, Alan Whone, Elizabeth Coulthard. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.03.2024.)

Background: Social cognitive impairments are prevalent in schizophrenia spectrum disorder (SSD) and have detrimental effects on functioning. Cognitive remediation (CR) has shown its efficacy in improving social cognitive impairments, although the transfer of these skills to daily life and the personalization of these interventions remain challenging. RC2S (Remédiation Cognitive de la Cognition Sociale dans la Schizophrénie; Cognitive remediation of social cognition in Schizophrenia) is a French CR that combines the learning of strategies and practice using paper-and-pencil exercises and digital relational simulations. This French program was designed as an in-person intervention., Objective: This project aims to culturally adapt the RC2S program, in French-Canadian and North American English and to assess the feasibility, acceptability, safety, and implementation of a remote version in people with SSD. An exploratory objective is to assess the preliminary effect of remote RC2S on goal attainment, social cognition, and psychosocial outcomes., Methods: We will use a pre-post quasi-experimental design. First, the translation and cultural adaptation in North American English and French-Canadian of RC2S is presented. Then, 20 participants aged ≥18 years with a diagnosis of SSD, presenting with a subjective or an objective impairment in social cognition, will be included to receive RC2S. In addition, 5 therapists will be included as research participants to assess their perspective on RC2S. Participants with SSD will undergo a baseline remote assessment of their social cognition, clinical symptoms, and functioning. They will then start remote RC2S for 24 biweekly individual 1-hour sessions with a therapist. Following the case formulation and goal setting, participants will complete personalized paper-and-pencil exercises to develop strategies and integrative digital relational simulations, during which they will help an avatar navigate through a variety of social contexts and relationships. The last 2 sessions are dedicated to the transfer to daily life. All participants will complete in-session questionnaires assessing therapeutic alliance, motivation, acceptability, feasibility, and implementation. Following RC2S, the participants with SSD will repeat the same assessment as the baseline. Descriptive statistics will be used to summarize the data about acceptability, feasibility, safety, and implementation. To assess the preliminary effect of RC2S, an intention-to-treat approach will be used with linear mixed models for repeated measures with fixed effects of time., Results: So far, 45% (9/20) of participants with SSD (mean age 37.9, SD 9.3 years) have completed the project. They received a mean of 20.5 out of 24 (SD 3.5) sessions of RC2S. A total of 5 therapists also completed the project., Conclusions: Improving social cognitive impairments is an important target in SSD to promote functional recovery. Using digital technologies to address these impairments and deliver the intervention is a promising approach to increase the ecological validity of CR and access to the intervention., Trial Registration: ClinicalTrials.gov NCT05017532; https://classic.clinicaltrials.gov/ct2/show/NCT05017532., International Registered Report Identifier (irrid): DERR1-10.2196/54251., (©Elisabeth Thibaudeau, Elodie Peyroux, Nicolas Franck, Hannah Carling, Martin Lepage. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.03.2024.)

Background: Vulnerable older adults have a high risk of morbidity and mortality. Regular physical activity (PA) can have a positive effect on the health and health-related behavior of this specific target group. However, evidence of the impact and feasibility of community-based PA promotion interventions for vulnerable older adults is still limited., Objective: The BeTaSen (Bewegungs-Tandems in den Lebenswelten Chemnitzer Seniorinnen und Senioren: ein Beitrag zur kommunalen Gesundheitsförderung) study aims to evaluate the (1) impact as well as the (2) feasibility, acceptance, and usefulness of a 12-month low-threshold PA intervention program for community-dwelling vulnerable older adults., Methods: For our population-based prospective observational cohort study, a total of 120 vulnerable older adults (aged 75 years or older) in the area of Chemnitz (Germany) will be recruited to participate in (1) weekly neighborhood-based low-threshold PA meetings with trained mentors (activity tandems) and (2) monthly exercise meetings led by trained exercise instructors. Within the intervention, participants will be encouraged to perform the PA independently. Participants will complete assessments, which will include questionnaires as well as objective measurements of their physical, cognitive, and psychosocial health at 3 different time points (baseline, 6 months after the start, and 6 months after the end of the intervention). Additionally, a process evaluation will be performed, including questionnaires and qualitative interviews, involving the participants, mentors, and municipal project partner representatives., Results: The BeTaSen project process began in October 2021, with the start of data collection and intervention in August 2022 in the first neighborhoods of the city of Chemnitz. A total of 86 participants were recruited at the time of submission of the manuscript. Longitudinal results are expected by 2025., Conclusions: This study's results will provide insights on (1) the PA behavior of vulnerable older adults as well as the impact of PA interventions on health-related outcomes such as cognitive, physical, and psychosocial health, and (2) the feasible and useful components of community-based PA interventions. Thus, this pilot study contributes to future recommendations and provides a basis for further research, such as the development of feasible and sustainable target group-specific interventions in community settings., International Registered Report Identifier (irrid): DERR1-10.2196/51462., (©Tina Auerswald, Katharina Zwingmann, Torsten Schlesinger, Katrin Müller. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.02.2024.)

Background: Patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer often experience a reduced quality of life after primary treatment. The disease and treatment trajectory consists of surgery followed by chemotherapy or radiation therapy. Upon this, maintenance hormone therapy with an aromatase inhibitor can result in several physical and psychosocial symptoms. Optimal symptom control during maintenance therapy is central to maintaining the patient's quality of life., Objective: This study aims to (1) develop an electronic symptom management tool for patients with postmenopausal early breast cancer receiving maintenance aromatase inhibitors with an endocrine aspect and (2) assess the feasibility, acceptability, and usability of the pilot version of the Bone@BC app. Furthermore, longitudinally, symptom prevalence and quality of life for patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will be explored., Methods: This study follows a multistage research plan. In stage 1, a systematic literature review to establish an overview of aromatase inhibitor-related symptoms reported by postmenopausal women with nonmetastatic estrogen receptor-positive breast cancer will be completed. In stage 2, a comprehensive overview of symptoms related to aromatase inhibitors (letrozole, exemestane, and anastrozole) will be performed (eg, by reviewing medical leaflets and guidelines). In stage 3, an electronic app with a user-friendly Patient Concern Inventory list to comprise symptoms and concerns will be developed. Last, in stage 4, a convergent mixed methods feasibility study of the pilot version of the Bone@BC app will be conducted. A total of 45 patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will use the app daily for symptom identification and respond to 6 serial patient-reported outcome measurements for 12 weeks. Finally, semistructured interviews will be performed. The primary outcome includes consent rate, attrition rate, retention rates, technical issues, and adherence, assessed using preestablished criteria on feasibility and a mixed methods approach for exploring acceptability. A patient advisory board consisting of 5 women with breast cancer is recruited to include their perspectives and experiences in the planning, organization, implementation, and dissemination of the research throughout the project., Results: At the time of submitting this paper (January 2024), a total of 23 patients have been included in the stage 2 medical audit over the recruitment period of 3 months (November 2022 to February 2023), and 19 patients have been enrolled in stage 2, the semistructured patient interviews., Conclusions: This protocol describes a study investigating the feasibility, acceptability, and usability of the symptom management tool Bone@BC developed for patients with breast cancer with an endocrine aspect., Trial Registration: ClinicalTrails.gov NCT05367830; https://clinicaltrials.gov/ct2/show/NCT05367830., International Registered Report Identifier (irrid): DERR1-10.2196/49549., (©Trine Lund-Jacobsen, Peter Schwarz, Gabriella Martino, Helle Pappot, Karin Piil. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 15.02.2024.)

Background: Acceptability and preference research play a crucial role in the design, evaluation, and implementation of any new prevention product in any geographical setting. They also play a critical role in the development of clinical guidelines and policies. A wide range of acceptability studies have been conducted in diverse general and key populations for various new HIV prevention products worldwide. As clinical development strategies are being developed for clinical studies of broadly neutralizing antibodies (bNAbs) as potential HIV prevention products, appropriately tailoring them to address the type of HIV epidemic at hand would be critical for efficient uptake within in-country public health systems and decrease adoption and adherence challenges. Accomplishing this will require comprehensive acceptability and feasibility studies to inform multisectoral efforts that increase access to these products and national policies supportive of access to health care for those in most need. Thus, it is both opportune and important to undertake focused efforts toward informing product development strategies., Objective: This study aims to understand preferences for product attributes and key behavioral factors influencing adoption and uptake of bNAb prevention products among end-users including female sex workers, men who have sex with men, transgender women, people who inject drugs, and adolescent girls and young women in India and understand the key health system and programmatic perspectives toward the introduction of bNAb prevention products from health service providers and policy makers in India., Methods: A multisite study will be conducted in Delhi, Mumbai, and Chennai to capture the differences in perspectives among diverse end-users and key informants across the country. The study will use a multimethods design using focus group discussions, in-depth interviews, simulated behavioral experiments, and key informant interviews. A total of 30 focus group discussions, 45 in-depth interviews, 15 simulated behavioral experiments sessions, and 15 key informant interviews will be conducted across 3 sites., Results: The data collected and analyzed will enable insights on which specific product attributes matter the most to the populations and why some attributes are less preferred; contextual drivers of preferences and choices at individual, interpersonal, social, and structural levels; and relative positioning of bNAb products among other potential HIV prevention products. Insights from the health service providers and policy makers will provide a critical understanding of the need perception of the potential product in the existing product landscape and what additional efforts and resources are required for potential introduction, delivery, and uptake of the bNAb products in the Indian context., Conclusions: Insights generated from the abovementioned objectives will represent perspectives of populations of interest across geographies in India, will provide an overview of the acceptability of bNAb products and the feasibility of their introduction in this region, and will inform product development strategies., International Registered Report Identifier (irrid): DERR1-10.2196/47700., (©Joyeeta Mukherjee, Shruta Rawat, Saif ul Hadi, Pritha Aggarwal, Venkatesan Chakrapani, Pratyasha Rath, Pallavi Manchi, Srikrishnan Aylur, Shelly Malhotra, Margaret Keane, Alok Gangaramany. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 07.02.2024.)

Background: Chronic musculoskeletal pain is prevalent and disabling among older adults in underserved communities. Psychosocial pain management is more effective than pharmacological treatment in older adults. However, underserved community clinics often lack psychosocial treatments, in part because of a lack of trained providers. Shared medical appointments, in which patients undergo brief medical evaluation, monitoring, counseling, and group support, are an efficacious and cost-effective method for chronic disease management in underserved clinics, reducing the need for specialized providers. However, shared medical visits are often ineffective for chronic pain, possibly owing to lack of inclusion of skills most relevant for older adults (eg, pacing to increase engagement in daily activities)., Objective: We have described the protocol for the development and initial pilot effectiveness testing of the GetActive+ mind-body activity intervention for older adults with chronic pain. GetActive+ was adapted from GetActive, an evidence-based intervention that improved pain outcomes among mostly affluent White adults. We aim to establish the initial feasibility, acceptability, fidelity, and effectiveness of GetActive+ when delivered as part of shared medical appointments in a community clinic., Methods: We conducted qualitative focus groups and individual interviews with providers (n=25) and English-speaking older adults (aged ≥55 y; n=18) with chronic pain to understand the pain experience in this population, perceptions about intervention content, and barriers to and facilitators of intervention participation and implementation in this setting. Qualitative interviews with Spanish-speaking older adults are in progress and will inform a future open pilot of the intervention in Spanish. We are currently conducting an open pilot study with exit interviews in English (n=30 individuals in total). Primary outcomes are feasibility (≥75% of patients who are approached agree to participate), acceptability (≥75% of patients who enrolled complete 8 out of 10 sessions; qualitative), and fidelity (≥75% of session components are delivered as intended). Secondary outcomes include physical function-self-reported, performance based (6-minute walk test), and objective (step count)-and emotional function (depression and anxiety). Other assessments include putative mechanisms (eg, mindfulness and pain catastrophizing)., Results: We began enrolling participants for the qualitative phase in November 2022 and the open pilot phase in May 2023. We completed the qualitative phase with providers and English-speaking patients, and the results are being analyzed using a hybrid, inductive-deductive approach. We conducted rapid analysis of these data to develop GetActive+ before the open pilot in English, including increasing readability and clarity of language, reducing the number of skills taught to increase time for individual check-ins and group participation, and increasing experiential exercises for skill uptake., Conclusions: We provide a blueprint for the refinement of a mind-body activity intervention for older adults with chronic pain in underserved community clinics and for incorporation within shared medical visits. It will inform a future, fully powered, effectiveness-implementation trial of GetActive+ to help address the chronic pain epidemic among older adults., Trial Registration: ClinicalTrials.gov NCT05782231; https://clinicaltrials.gov/study/NCT05782231., International Registered Report Identifier (irrid): DERR1-10.2196/52117., (©Katherine McDermott, Nadine Levey, Julie Brewer, Madison Ehmann, Julia E Hooker, Roger Pasinski, Neda Yousif, Vidya Raju, Milton Gholston, Jonathan Greenberg, Christine S Ritchie, Ana-Maria Vranceanu. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.12.2023.)

Background: Cannabis use is highly prevalent in young people with first-episode psychosis (FEP). Most report cannabis use and are often diagnosed with a cannabis use disorder upon admission to specialized services for psychosis. Cannabis use in this population is associated with worse clinical and psychosocial outcomes, rendering it an important clinical target. Despite this, few cannabis-specific interventions have been developed for FEP and empirically evaluated through randomized controlled trials. Most evaluated interventions have targeted cannabis abstinence, with limited efficacy, but none have centered on harm reduction outcomes for people with FEP who use cannabis. Early intervention services (EIS), the standard of care for FEP, have not successfully addressed problematic cannabis use in people with FEP either. Clinical trials are needed to explore the potential of harm reduction strategies, although these should be preceded by robust pilot studies to establish optimal design and approaches., Objective: Recognizing the need for harm reduction strategies for individuals with FEP who use cannabis and based on research on patients' preferences supporting harm reduction interventions, we developed a mobile app-based cannabis harm reduction intervention for this population. This intervention is called Cannabis Harm-reducing Application to Manage Practices Safely (CHAMPS). Here, we describe the protocol for a multicenter, 2-arm, parallel group, randomized pilot trial evaluating the acceptability of CHAMPS for people with FEP who use cannabis and the feasibility of conducting a full-scale trial in this population using CHAMPS. The impact on key clinical outcomes will also be explored., Methods: This pilot trial aims to recruit 100 young people with FEP using cannabis from 6 Canadian EIS clinics. Participants will be randomized in a 1:1 ratio to CHAMPS+EIS or EIS-only. CHAMPS acceptability will be assessed using completion rates for the intervention arm. Trial feasibility will be assessed using a retention rate for randomized participants. Secondary outcomes will explore tendencies of change in the use of protective behavioral strategies and in motivation to change strategies. Exploratory outcomes include cannabis use-related problems, other substance use, the severity of dependence, psychotic symptoms, and health care service use., Results: Recruitment began in December 2021. Data collection and analysis are expected to be completed in early 2024. Study results describing CHAMPS acceptability and trial feasibility will then be submitted for publication in a peer-reviewed journal., Conclusions: CHAMPS uniquely combines evidence-based approaches, patient perspectives, and mobile health technology to support harm reduction in people with FEP who use cannabis. Attaining adequate acceptability and feasibility through this trial may justify further exploration of harm reduction tools, particularly within the context of conducting a larger-scale randomized controlled trial. This pilot trial has the potential to advance knowledge for researchers and clinicians regarding a feasible and user-acceptable research design in the cannabis and early psychosis fields., Trial Registration: ClinicalTrials.gov NCT04968275, https://clinicaltrials.gov/ct2/show/NCT04968275., International Registered Report Identifier (irrid): DERR1-10.2196/53094., (©Stephanie Coronado-Montoya, Amal Abdel-Baki, José Côté, David Crockford, Simon Dubreucq, Benedikt Fischer, Pamela Lachance-Touchette, Tania Lecomte, Sophie L'Heureux, Clairélaine Ouellet-Plamondon, Marc-André Roy, Ovidiu Tatar, Phillip Tibbo, Marie Villeneuve, Anne Wittevrongel, Didier Jutras-Aswad. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 18.12.2023.)

Background: The increasing burden of depression and noncommunicable disease (NCD) is a global challenge, especially in low- and middle-income countries, considering the resource constraints and lack of trained human resources in these settings. Effective treatment of depression in people with NCDs has the potential to enhance both the mental and physical well-being of this population. It will also result in the effective use of the available health care resources. Brief psychological therapies, such as behavioral activation (BA), are effective for the treatment of depression. BA has not been adapted in the community health care services of India, and the feasibility of using BA as an intervention for depression in NCD and its effectiveness in these settings have not been systematically evaluated., Objective: Our objective is to adapt BA for the Indian NCD context and test the acceptability, feasibility, and implementation of the adapted BA intervention (BEACON intervention package [BIP]). Additionally, we aim to test the feasibility of a randomized controlled trial evaluation of BIP for the treatment of depression compared with enhanced usual care., Methods: Following well-established frameworks for intervention adaptation, we first adapted BA (to fit the linguistic, cultural, and resource context) for delivery in India. The intervention was also adapted for potential remote delivery by telephone. In a randomized controlled trial, we will be testing the acceptability, feasibility, and implementation of the adapted BA intervention (BIP). We shall also test if a randomized controlled feasibility trial can be delivered effectively and estimate important parameters (eg, recruitment and retention rates and completeness of follow-up) needed to design a future definitive trial., Results: Following the receipt of approval from all the relevant agencies, the development of the BIP was started on November 28, 2020, and completed on August 18, 2021, and the quantitative data collection was started on August 23, 2021, and completed on December 10, 2021. Process evaluation (qualitative data) collection is ongoing. Both the qualitative and quantitative data analyses are ongoing., Conclusions: This study may offer insights that could help in closing the gap in the treatment of common mental illness, particularly in nations with limited resources, infrastructure, and systems such as India. To close this gap, BEACON tries to provide BA for depression in NCDs through qualified NCD (BA) counselors integrated within the state-run NCD clinics. The results of this study may aid in understanding whether BA as an intervention is acceptable for the population and how feasible it will be to deliver such interventions for depression in NCD in South Asian countries such as India. The BIP may also be used in the future by Indian community clinics as a brief intervention program., Trial Registration: Clinical Trials Registry of India CTRI/2020/05/025048; https://tinyurl.com/mpt33jv5., International Registered Report Identifier (irrid): DERR1-10.2196/41127., (©Rayeesa Zainab, Arun Kandasamy, Naseer Ahmad Bhat, Chrishma Violla Dsouza, Hannah Jennings, Cath Jackson, Papiya Mazumdar, Catherine Elizabeth Hewitt, David Ekers, Gitanjali Narayanan, Girish N Rao, Karen Coales, Krishna Prasad Muliyala, Santosh K Chaturvedi, Pratima Murthy, Najma Siddiqi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.11.2023.)

Background: Exergame-based motor-cognitive training in older adults has been associated with improvements in physical, cognitive, and psychological functioning. The novel Cocare system (Dividat GmbH), developed through a user-centered design process, allows motor-cognitive training in a telerehabilitation setting. It includes (1) a stationary stepping platform for supervised exergame training (Dividat Senso; Dividat GmbH), (2) a home-based version (Dividat Senso Flex, which is a rollable pressure-sensitive mat; Dividat GmbH), (3) an assessment system (including motor-cognitive tests), and (4) a rehabilitation cockpit for remote training supervision and management., Objective: The aim of this study is to test the feasibility and effectiveness of this novel training system., Methods: A total of 180 older adults from Switzerland, Italy, and Cyprus aged ≥60 years with a prescription for rehabilitation are randomly allocated to an intervention group or a control group. Both groups continue with their usual care, whereas participants in the intervention group additionally perform a 2-week supervised exergame training program at rehabilitation centers, followed by a 10-week home training program under remote supervision. The assessment system is used to indicate the start level of each participant, and, in both intervention periods, standardized progression rules are applied. The measures of feasibility include adherence, attrition, exergame enjoyment, willingness to perform such a training program, and the number and types of help requests. Effectiveness is assessed in terms of cognitive and physical functioning, balance confidence, and quality of life., Results: Data collection started in February 2023 and is ongoing. Final measurements are expected to be performed in January 2024., Conclusions: Owing to the user-centered design approach, the Cocare system is expected to be user-friendly and offers several novel features to cover the whole continuum of care. This pragmatic trial will provide valuable information regarding final necessary adaptations and subsequent implementation efforts., Trial Registration: ClinicalTrials.gov NCT05751551; https://www.clinicaltrials.gov/study/NCT05751551., International Registered Report Identifier (irrid): DERR1-10.2196/49377., (©Julia Seinsche, Eling D de Bruin, Enrico Saibene, Francesco Rizzo, Ilaria Carpinella, Maurizio Ferrarin, Sarina Ifanger, Sotiria Moza, Eleftheria Giannouli. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.11.2023.)

Background: Chronic fatigue is a common symptom among patients who have been treated for cancer. Current psychosocial interventions typically target the patient alone, despite growing evidence suggesting that a couples' approach can increase and broaden the efficacy of an intervention. Therefore, based on an existing web-based mindfulness-based cognitive therapy for patients, the couple intervention COMPANION was developed., Objective: The primary objectives of this study are to determine the acceptability of COMPANION and its potential efficacy in reducing fatigue in patients with cancer. Our secondary objectives are to examine the feasibility of the trial procedures and the potential working mechanisms of the couple intervention., Methods: We will conduct a single-arm pilot trial for couples (ie, patients with cancer with chronic fatigue and their partners). All couples are allocated to the web-based couple intervention that consists of psychoeducation, mindfulness, and cognitive-behavioral exercises. The 9 sessions of the intervention are supervised remotely by a trained therapist. Patients and partners will complete questionnaires before starting the intervention (T0), 2 weeks after completing the intervention (T1), and 1 month after T1 (T2). They will also fill out weekly diaries during the intervention period. A subsample of patients (n≈5) and partners (n≈5) as well as all the therapists providing COMPANION will participate in the final focus groups. Benchmark values have been defined to determine the acceptability (ie, ≥60% of couples complete the intervention and/or ≥70% of the participants are satisfied with the intervention) and potential efficacy (ie, a significant improvement in fatigue and/or a clinically relevant improvement in fatigue in 45% of the patients between T0 and T1) of the intervention. The trial procedures are deemed feasible if an average of at least three couples are included per recruiting month and/or adherence to the assessments is at least 65% for T1 and the diaries and 60% for T2. To establish potential working mechanisms, changes in affect, sleep, catastrophizing, partner communication and interactions, self-efficacy, mindfulness, and closeness will be examined. Quantitative outcomes will be interpreted along with the results from the focus groups., Results: Data collection is expected to be completed by March 2024., Conclusions: This pilot trial will test the first web-based mindfulness-based cognitive therapy for couples targeting chronic cancer-related fatigue. Findings will indicate whether proceeding with a randomized controlled trial is warranted., Trial Registration: ClinicalTrials.gov NCT05636696; https://clinicaltrials.gov/study/NCT05636696., International Registered Report Identifier (irrid): DERR1-10.2196/48329., (©Fabiola Müller, Sophie van Dongen, Rosalie van Woezik, Marijke Tibosch, Marrit A Tuinman, Melanie P J Schellekens, Jean-Philippe Laurenceau, Marije van der Lee, Mariët Hagedoorn. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.11.2023.)

Background: Academic procrastination is a widespread problem among college students. It is linked to poor academic performance and increased college dropout intentions, as well as several mental health problems such as depression, anxiety, and stress. Guided web-based interventions can help reduce procrastination. However, guidance by professional clinicians draws upon valuable and limited societal resources, and a more efficient, scalable form of guidance is needed. Guidance by trained clinical psychology students has not yet been examined., Objective: The aim of this open trial is to examine the feasibility and acceptability of a web-based procrastination intervention for college students under the guidance of student digital coaches (e-coaches)., Methods: We developed a single-arm trial of a guided web-based intervention targeting procrastination for the Dutch student population. Guidance is delivered by trained clinical psychology students asynchronously in the form of textual feedback on intervention progress, with the aim of supporting and motivating the participant. Participants are recruited at 7 Dutch universities. Primary outcomes are intervention satisfaction, usability, and adherence, which are assessed by the Client Satisfaction Scale (CSQ-8), System Usability Scale (SUS-10), and number of completed modules, respectively. The primary outcomes will be examined by calculating descriptive statistics. Secondary outcomes are e-coach satisfaction and changes to procrastination, depression, stress, and quality of life from pre- to posttest and follow-up., Results: The project was funded in 2019, and recruitment began in January 2021. As of May 2023, a total of 985 participants were enrolled, of which 372 had completed the posttest and 192 had completed the follow-up. The expected date of analysis and publication of the results is 2024., Conclusions: The results are expected to contribute to the body of literature regarding eHealth in 3 ways. First, we will examine whether students who procrastinate adhere to and are satisfied with an eHealth intervention targeting this problem. Second, we will explore whether an intervention targeting procrastination can also decrease depression and stress. Lastly, we will investigate whether trained psychology students can effectively guide their peers in web-based interventions. Given the shortage of licensed psychologists, exploring alternative sources of guidance is much needed in order to provide students with the mental health support they need., International Registered Report Identifier (irrid): DERR1-10.2196/44907., (©Sevin Ozmen, Arpana Amarnath, Sascha Struijs, Leonore de Wit, Pim Cuijpers. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 03.11.2023.)

Background: Spinal muscular atrophy (SMA) is a progressive neuromuscular disorder that causes muscle weakness and is the leading genetic cause of infant mortality worldwide. While no definitive cure exists, the approval of 3 genetic-based therapies in Canada since 2018 has led to significant improvements in muscle function for children with SMA. With that, there are no evidence-based rehabilitation interventions and minimal evidence on the combined effects of genetic-based therapies and rehabilitation., Objective: This protocol describes the methodology to assess the feasibility of a twice-weekly outpatient rehabilitation intervention focusing on gross and fine motor function to inform the methodology and sample size of a definitive clinical trial., Methods: We will conduct a single-center nonrandomized pilot and feasibility trial to explore an outpatient rehabilitation intervention for children aged 6 months to 3 years with SMA treated with genetic-based therapies. Participation in the study will occur over a 25-week period, with a baseline assessment visit followed by a 12-week intervention period and a 12-week nonintervention period. The rehabilitation intervention comprises weekly physical and occupational therapy for 11 weeks. Assessments will occur at baseline (week 0), end of intervention or early withdrawal (week 12), and follow-up (week 24). Predetermined feasibility indicators will evaluate study feasibility across process (recruitment rates, eligibility criteria, adherence rates, retention rates, questionnaire suitability, and acceptability), resource (time, implementation, and execution), management (materials and data), and scientific (safety, tolerability, and preliminary efficacy) domains., Results: This project was funded in March 2022, and data will be collected between March 2023 and December 2023. Data analysis will occur between January 2024 and March 2024, with publication expected in the fall of 2024. The protocol for the feasibility trial will be considered successful if it meets the success criteria set out for the feasibility indicators. Indicators of specific interest include all process indicators, as well as time. Exploratory indicators will be reported. Pragmatically, the results of the feasibility trial will inform changes to the protocol and the start-up of a definitive multisite trial., Conclusions: This novel twice-weekly outpatient rehabilitation intervention will be the first step toward filling the need for an evidence-based rehabilitation intervention for children with SMA treated with genetic-based therapies. It is expected that consistent and intensive rehabilitation therapy will augment functional gains being observed in this population. In the future, a definitive trial will measure the efficacy of the intervention., Trial Registration: ClinicalTrials.gov NCT05638750; https://clinicaltrials.gov/study/NCT05638750., International Registered Report Identifier (irrid): DERR1-10.2196/46363., (©Christina Ippolito, Lathushikka Canthiya, Amanda Floreani, Kathleen Luckhart, Andrea Hoffman, Laura McAdam. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 02.11.2023.)

Background: Chronic or persistent pain affects one's ability to work or be productive at work, generating high societal and economic burden. However, the provision of work-related advice and support for people with chronic pain is variable or lacking. The Pain-at-Work (PAW) Toolkit was cocreated with people who live with pain, health care professionals, and employers. It aims to increase knowledge about employee rights and how to access support for managing a painful chronic condition in the workplace and provides advice on lifestyle behaviors that facilitate the management of chronic pain., Objective: We aimed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing access to the PAW Toolkit and telephone support calls from an occupational therapist (PAW) with treatment as usual (ie, standard support from their employer). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, and safety of this digital workplace health intervention. We will assess the candidate primary and secondary outcomes' feasibility and test research processes for a definitive trial., Methods: This is an open-label, parallel 2-arm pragmatic feasibility cluster randomized controlled trial with exploratory health economics analysis and a nested qualitative interview study. We aim to recruit 120 participants from at least 8 workplace clusters (any type, >10 employees) in England. The recruitment of workplaces occurs via personal approach, and the recruitment of individual participants is web based. Eligible participants are vocationally active adults aged ≥18 years with internet access and self-reporting chronic pain interfering with their ability to undertake or enjoy productive work. A restricted 1:1 cluster-level randomization is used to allocate employment settings to PAW or treatment as usual; participants are unblinded to group allocation. Following site- and individual-level consent, participants complete a web-based baseline survey (time 0), including measures of work capacity, health and well-being, and health care resource use. Follow-up is performed at 3 months (time 1) and 6 months (time 2). Feasibility outcomes relate to recruitment; intervention fidelity (eg, delivery, reach, uptake, and engagement); retention; and follow-up. Qualitative evaluation (time 2) is mapped to the Capability, Opportunity, Motivation-Behavior model and will explore intervention acceptability to employees and employers, along with individual and contextual factors influencing the delivery and uptake of the intervention., Results: Ethics approval was obtained in March 2023. Trial recruitment began in June 2023., Conclusions: The PAW Toolkit is the first evidence-based digital health intervention aimed at supporting the self-management of chronic or persistent pain at work. This study will inform the design of a definitive trial, including sample size estimation, approaches to cluster site identification, primary and secondary outcomes' selection, and the final health economic model. Findings will inform approaches for the future delivery of this digital health intervention., Trial Registration: ClinicalTrials.gov NCT05838677; https://clinicaltrials.gov/study/NCT05838677., International Registered Report Identifier (irrid): DERR1-10.2196/51474., (©Holly Blake, Wendy J Chaplin, Elaine Wainwright, Gordon Taylor, Paul McNamee, Daniel McWilliams, Victoria Abbott-Fleming, Jain Holmes, Aaron Fecowycz, David Andrew Walsh, Karen Walker-Bone. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.10.2023.)

Background: In 2020, Greater New Orleans, Louisiana, was home to 7048 people living with HIV-1083 per 100,000 residents, 2.85 times the US national rate. With Louisiana routinely ranked last in indexes of health equity, violent crime rates in Orleans Parish quintupling national averages, and in-care New Orleans people living with HIV surviving twice the US average of adverse childhood experiences, accessible, trauma-focused, evidence-based interventions (EBIs) for violence-affected people living with HIV are urgently needed., Objective: To meet this need, we adapted Living in the Face of Trauma, a well-established EBI tailored for people living with HIV, into NOLA GEM, a just-in-time adaptive mobile health (mHealth) intervention. This study aimed to culturally tailor and refine the NOLA GEM app and assess its acceptability; feasibility; and preliminary efficacy on care engagement, medication adherence, viral suppression, and mental well-being among in-care people living with HIV in Greater New Orleans., Methods: The development of NOLA GEM entailed identifying real-time tailoring variables via a geographic ecological momentary assessment (GEMA) study (n=49; aim 1) and place-based and user-centered tailoring, responsive to the unique cultural contexts of HIV survivorship in New Orleans, via formative interviews (n=12; aim 2). The iOS- and Android-enabled NOLA GEM app leverages twice-daily GEMA prompts to offer just-in-time, in-app recommendations for effective coping skills practice and app-delivered Living in the Face of Trauma session content. For aim 3, the pilot trial will enroll an analytic sample of 60 New Orleans people living with HIV individually randomized to parallel NOLA GEM (intervention) or GEMA-alone (control) arms at a 1:1 allocation for a 21-day period. Acceptability and feasibility will be assessed via enrollment, attrition, active daily use through paradata metrics, and prevalidated usability measures. At the postassessment time point, primary end points will be assessed via a range of well-validated, domain-specific scales. Care engagement and viral suppression will be assessed via past missed appointments and self-reported viral load at 30 and 90 days, respectively, and through well-demonstrated adherence self-efficacy measures., Results: Aims 1 and 2 have been achieved, NOLA GEM is in Beta, and all aim-3 methods have been reviewed and approved by the institutional review board of Tulane University. Recruitment was launched in July 2023, with a target date for follow-up assessment completion in December 2023., Conclusions: By leveraging user-centered development and embracing principles that elevate the lived expertise of New Orleans people living with HIV, mHealth-adapted EBIs can reflect community wisdom on posttraumatic resilience. Sustainable adoption of the NOLA GEM app and a promising early efficacy profile will support the feasibility of a future fully powered clinical trial and potential translation to new underserved settings in service of holistic survivorship and well-being of people living with HIV., Trial Registration: ClinicalTrials.gov NCT05784714; https://clinicaltrials.gov/ct2/show/NCT05784714., International Registered Report Identifier (irrid): PRR1-10.2196/47151., (©Simone J Skeen, Stephanie Tokarz, Rayna E Gasik, Chelsea McGettigan Solano, Ethan A Smith, Momi Binaifer Sagoe, Lauryn V Hudson, Kara Steele, Katherine P Theall, Gretchen A Clum. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.10.2023.)

Background: Mental health problems affect 1 in 6 workers annually and are one of the leading causes of sickness absence, with stress, anxiety, and depression being responsible for half of all working days lost in the United Kingdom. Primary interventions with a preventative focus are widely acknowledged as the priority for workplace mental health interventions. Line managers hold a primary role in preventing poor mental health within the workplace and, therefore, need to be equipped with the skills and knowledge to effectively carry out this role. However, most previous intervention studies have directly focused on increasing line managers' understanding and awareness of mental health rather than giving them the skills and competencies to take a proactive preventative approach in how they manage and design work. The Managing Minds at Work (MMW) digital training intervention was collaboratively designed to address this gap. The intervention aims to increase line managers' knowledge and confidence in preventing work-related stress and promoting mental health at work. It consists of 5 modules providing evidence-based interactive content on looking after your mental health, designing and managing work to promote mental well-being, management competencies that prevent work-related stress, developing a psychologically safe workplace, and having conversations about mental health at work., Objective: The primary aim of this study is to pilot and feasibility test MMW, a digital training intervention for line managers., Methods: We use a cluster randomized controlled trial design consisting of 2 arms, the intervention arm and a 3-month waitlist control, in this multicenter feasibility pilot study. Line managers in the intervention arm will complete a baseline questionnaire at screening, immediately post intervention (approximately 6 weeks after baseline), and at 3- and 6-month follow-ups. Line managers in the control arm will complete an initial baseline questionnaire, repeated after 3 months on the waitlist. They will then be granted access to the MMW intervention, following which they will complete the questionnaire post intervention. The direct reports of the line managers in both arms of the trial will also be invited to take part by completing questionnaires at baseline and follow-up. As a feasibility pilot study, a formal sample size is not required. A minimum of 8 clusters (randomized into 2 groups of 4) will be sought to inform a future trial from work organizations of different types and sectors., Results: Recruitment for the study closed in January 2022. Overall, 24 organizations and 224 line managers have been recruited. Data analysis was finished in August 2023., Conclusions: The results from this feasibility study will provide insight into the usability and acceptability of the MMW intervention and its potential for improving line manager outcomes and those of their direct reports. These results will inform the development of subsequent trials., Trial Registration: ClinicalTrials.gov NCT05154019; https://clinicaltrials.gov/study/NCT05154019., International Registered Report Identifier (irrid): DERR1-10.2196/48758., (©Louise Thomson, Juliet Hassard, Alexandra Frost, Craig Bartle, Joanna Yarker, Fehmidah Munir, Richard Kneller, Steven Marwaha, Guy Daly, Sean Russell, Caroline Meyer, Benjamin Vaughan, Kristina Newman, Holly Blake. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.10.2023.)