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Background: People with severe mental illness (e.g. psychosis, bipolar disorder) experience poor oral health compared to the general population as shown by more decayed, missing and filled teeth and a higher prevalence of periodontal disease. Attending dental services allows treatment of oral health problems and support for prevention. However, people with severe mental illness face multiple barriers to attending routine dental appointments and often struggle to access care. Link work interventions use non-clinical support staff to afford vulnerable populations the capacity, opportunity, and motivation to navigate use of services. The authors have co-developed with service users a link work intervention for supporting people with severe mental illness to access routine dental appointments. The Mouth Matters in Mental Health Study aims to explore the feasibility and acceptability of this intervention within the context of a feasibility randomised controlled trial (RCT) measuring outcomes related to the recruitment of participants, completion of assessments, and adherence to the intervention. The trial will closely monitor the safety of the intervention and trial procedures. Methods: A feasibility RCT with 1:1 allocation to two arms: treatment as usual (control) or treatment as usual plus a link work intervention (treatment). The intervention consists of six sessions with a link worker over 9 months. Participants will be adults with severe mental illness receiving clinical input from secondary care mental health service and who have not attended a planned dental appointment in the past 3 years. Assessments will take place at baseline and after 9 months. The target recruitment total is 84 participants from across three NHS Trusts. A subset of participants and key stakeholders will complete qualitative interviews to explore the acceptability of the intervention and trial procedures. Discussion: The link work intervention aims to improve dental access and reduce oral health inequalities in people with severe mental illness. There is a dearth of research relating to interventions that attempt to improve oral health outcomes in people with mental illness and the collected feasibility data will offer insights into this important area. Trial registration: The trial was preregistered on ISRCTN (ISRCTN13650779) and ClinicalTrials.gov (NCT05545228). [ABSTRACT FROM AUTHOR]

Background: Law enforcement frequently responds to substance abuse and mental health crises. Crisis stabilization units (CSUs) operate as a public-receiving facility to provide short-term stabilization services for individuals experiencing these crises and offer law enforcement an important alternative to arrest. However, there is limited understanding about how and when law enforcement decides to use CSUs. There is also the challenge of retaining individuals in treatment after CSU stabilization to prevent future crises and persistent engagement with police. This study will respond to these gaps by exploring CSU procedures and examining the feasibility and acceptability of a technology-assisted mobile aftercare intervention designed for individuals brought to a CSU by law enforcement. Methods: This study will consist of three aims. Aim 1 will include qualitative interviews with law enforcement and CSU-affiliated mental health staff (n=80) regarding CSU utilization and collaboration logistics between the groups. Findings from Aim 1 will be synthesized for the development of an implementation guide of our intervention, mobile, and technology-assisted aftercare, designed for individuals brought to a CSU by law enforcement, during Aim 2. During Aim 2, intervention services will be pilot-tested for 6 months through a small sample (n=24), randomized control trial (RCT). Control participants will receive standard services available for individuals discharging from a CSU. Treatment participants will receive the mobile aftercare intervention. Qualitative and quantitative data will be collected at 2 weeks, 3 months, and 6 months post-recruitment for all study participants. Aims 1 and 2 will inform the design of a multi-site RCT to compare CSUs with and without mobile and technology-assisted aftercare (Aim 3). Discussion: The study will offer decision making and procedural insight into law enforcement use of CSUs as an alternative to jail and provide opportunities to inform that process. This research will provide outcome trends for those who go through standard CSU services compared to those who receive mobile and technology-assisted aftercare services. The current study will inform a larger RCT efficacy study of CSUs with and without technology-assisted aftercare services. Trial registration: This study was registered on ClinicalTrials.gov (reference #NCT04899934) on May 25, 2021. [ABSTRACT FROM AUTHOR]

Background: Women experiencing pregnancy after stillbirth experience high levels of anxiety, fear and depression. Standard antenatal care may be emotionally unsuitable for many women at this time, and there is a lack of evidence on what interventions or approaches to care might benefit these women. Therapeutic massage may assist women after stillbirth by decreasing anxiety, worry and stress. Objective: This paper outlines the objectives, methodology, outcome and assessment measures for the Helping suppOrt individuals Pregnant after Experiencing a Stillbirth (HOPES) feasibility trial which evaluates massage as an adjunct approach to care for pregnant women who have experienced a prior stillbirth. It also outlines data collection timing and considerations for analysing the data. Methods: HOPES will use a convergent parallel mixed-methods, single-arm repeated measures trial design in trained massage therapists' private clinics across Australia. HOPES aims to recruit 75 individuals pregnant after a previous stillbirth. The intervention is massage therapy treatments, and participants will receive up to five massages within a 4-month period at intervals of their choosing. Primary quantitative outcomes are the feasibility and acceptability of the massage intervention. Secondary outcomes include determining the optimal timing of massage therapy delivery and the collection of measures for anxiety, worry, stress and self-management. A thematic analysis of women's experiences undertaking the intervention will also be conducted. A narrative and joint display approach to integrate mixed-methods data is planned. Discussion: The HOPES study will determine the feasibility and preliminary evidence for massage therapy as an intervention to support women who are pregnant after a stillbirth. Trial registration. ClinicalTrials.gov NCT05636553. Registered on December 3, 2022, and the trial is ongoing. [ABSTRACT FROM AUTHOR]

Background: Although internet-based stress management programs are proven effective in improving mental health among workers, micro- and small-sized enterprises (MSEs), lacking in occupational healthcare services, face challenges implementing them. To address this gap, this study will develop the program with stakeholders at MSEs to aim for real-world implementation. Objectives: This paper describes a study protocol for a pre-post feasibility study of an effectiveness-implementation hybrid type 2 trial of text-based internet-based programs ("WellBe-LINE") in MSEs with less than 50 employees. This feasibility study primarily aims to evaluate trial methods for future effectiveness-implementation hybrid type 2 trials. Methods: For this study protocol, an internet- and text-based self-care intervention program using the LINE app (a popular message tool in Japan) will be prepared according to evidence-based psychoeducational topics. Based on our online survey findings, personalized algorithms will be implemented according to employees' gender, age, and psychological distress levels. A personalized program using a popular pre-existing text app is expected to reduce employees' burdens and be attractive to them, resulting in successful implementation outcomes and mental health benefits. A pre-post design feasibility study will be conducted on ten companies to evaluate trial methods (e.g., recruitment and procedures). The primary outcome will involve individual-level penetration, defined as the proportion of the number of employees who register for the program divided by the total number of invited employees at the company. The progression criterion to go next trial specifies that more than 50% of the recruited companies obtain 60% individual penetration, which is set based on the findings of the prior survey of employees at MSEs and of interviews of stakeholders involved in this study, and will be measured by LINE system. Finally, acceptability, appropriateness, and feasibility will be measured using internet-based questionnaires and interviews. Discussion: This pre-post feasibility study for future effectiveness-implementation hybrid type 2 trials will provide in-depth knowledge about the successful implementation of text-based, semi-personalized, self-care mental health interventions in real-world settings using both quantitative and qualitative data. Conclusions: This feasibility study will help validate the effectiveness of text-based interventions using a widely used social networking service (SNS) tool for employees in MSEs. Trial registration: UMIN clinical trial registration, UMIN000046960. Registered on February 21, 2022. https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053570 [ABSTRACT FROM AUTHOR]

Background: Pregnancy weight management interventions can improve maternal diet, physical activity, gestational weight gain, and postnatal weight retention. UK guidelines were published in 2010 but health professionals report multiple complex barriers to practice. GLOWING used social cognitive theory to address evidence-based barriers to midwives' implementation of weight management guidelines into routine practice. This paper reports the pilot trial outcomes relating to feasibility and acceptability of intervention delivery and trial procedures. Methods: GLOWING was a multi-centre parallel-group pilot cluster RCT comparing the delivery of a behaviour change intervention for midwives (delivered as training workshops) with usual practice. The clusters were four NHS Trusts in Northeast England, randomised to intervention or control arms. Blinding of allocation was not possible due to the nature of the intervention. We aimed to deliver the intervention to all eligible midwives in the intervention arm, in groups of 6 midwives per workshop, and to pilot questionnaire data collection for a future definitive trial. Intervention arm midwives' acceptability of GLOWING content and delivery was assessed using a mixed methods questionnaire, and pregnant women's acceptability of trial procedures by interviews. Quantitative data were analysed descriptively and qualitative data thematically. Results: In intervention arm Trusts, 100% of eligible midwives (n = 67) were recruited to, and received, the intervention; however, not all workshops had the planned number of attendees (range 3–8). The consent rate amongst midwives randomised (n = 100) to complete questionnaires was 74% (n = 74) (95% CI 65%, 83%), and overall completion rate 89% (n = 66) (95% CI 82%, 96%). Follow-up response rate was 66% (n = 49) (95% CI 55%, 77%), with a marked difference between intervention (39%, n = 15) and control (94%, n = 34) groups potentially due to the volume of research activities. Overall, 64% (n = 47) (95% CI 53%, 75%) completed both baseline and follow-up questionnaires. Midwives viewed the intervention as acceptable and directly relevant to routine practice. The least popular components related to scripted role-plays. Pregnant women viewed the recruitment and trial processes to be acceptable. Conclusions: This rigorously conducted pilot study demonstrated feasibility intervention delivery and a high level of acceptability amongst participants. It has provided information required to refine the intervention and trial protocol, enhancing confidence that a definitive trial could be carried out. Trial registration: ISRCTN46869894; retrospectively registered 25th May 2016, www.isrctn.com/ISRCTN46869894. [ABSTRACT FROM AUTHOR]

Background: Various service provision models for youth at risk of homelessness have been researched and implemented, including access to housing and physical and mental health resources. However, even with these interventions, we remain unaware of how best to manage symptoms of depression and anxiety and the rate of drug use in these populations primarily because of a lack of feasibility data. Methods: This paper presents the results of a mixed-methods study in London, Canada, that examined the feasibility of implementing a biopsychosocial intervention, SKY Schools, in at-risk youth aged between 16 and 25 (n = 49). The study also recorded qualitative responses about the program's usefulness from the perspective of the service users. The SKY Schools intervention consisted of social-emotional learning combined with Sudarshan Kriya Yoga, a standardized yoga-based breathing exercise routine. The intervention program was divided into two phases: an active learning phase and a reinforcement phase. The following feasibility outcome measures were collected: (1) the number of potential participants approached per month, (2) number (proportion) who were successfully screened, (3) the proportion of screened participants who enrolled, (4) the rate of retention in the study, (5) rate of adherence to study protocol, (6) proportion of planned ratings that were completed, (7) intervention cost per case, (8) completeness of final data for analysis, (9) length of time to collect all data, (10) quality of all collected data, (11) determining if partnering community organizations were willing to conduct the study as per study protocol, (12) determining if there were any capacity issues with partners providing intervention and investigators being able to perform the tasks that they were committed to doing, (13) determining if there were any problems of entering the data into a computer, (14) preliminary data about the safety of the intervention, and (15) preliminary estimate of treatment effects. Results: All feasibility outcome measures were collectible. In the city of London, Canada it was feasible to conduct a pilot study in this population of youth at risk of homelessness. Foremost among the findings was a high retention rate (61.2%) and overall positive qualitative feedback with a number of potential suggestions to improve the delivery and quality of the intervention. However, we had a significantly low recruitment rate (0.27 participants per week) suggesting that multiple sites will be needed to achieve an adequate sample size for a subsequent definitive trial. Conclusions: Future researchers may consider the findings of this feasibility study when designing a randomized control trial to further assess the efficacy and tolerability of SKY Schools. Trial registration: Trial registration: Clinicaltrials.gov, identifier NCT02749240. Registered April 22, 2016, https://clinicaltrials.gov/ct2/show/NCT02749240. [ABSTRACT FROM AUTHOR]

Background: Evaluating the effectiveness of early years parenting interventions provides evidence to improve the development and wellbeing of children. This protocol paper describes a study to explore the feasibility of evaluating the Incredible Years Toddler early life intervention programme, which is offered to parents of 1–3-year-olds via the Better Start Bradford programme. The study aims to use a Trial within a Cohort Study (TwiCS) design that randomly selects individuals participating in a cohort to be offered an intervention. The TwiCS information and consent process is person-centred and aims to replicate real-world practice whereby only those who are offered the intervention are given information about the intervention. The cohort is the Born in Bradford's Better Start (BiBBS) cohort, an interventional birth cohort recruiting expectant parents in three areas of Bradford, UK. The study will assess the feasibility of TwiCS procedures, staged consent, and intervention take-up. Methods: We will conduct a feasibility TwiCS to test study procedures. We aim to establish the following: (1) whether TwiCS methodology can be implemented to create control and intervention arms, whilst documenting any incidences of contamination within the cohort; (2) whether satisfactory rates of intervention uptake are achieved among participants allocated to the intervention; and (3) whether satisfactory rates of retention of participants in the intervention can be achieved. A Red Amber Green (RAG) rating system has been applied to support the feasibility assessment of each objective: to be rated red (not achieved), amber (partly achieved), and green (achieved). Eligible participants in the BiBBS cohort will be individually randomised 1:1 to the intervention or control arms, with stratification by child age (1 or 2 years old at the time of randomisation) and ethnicity (White British, South Asian, or other). BiBBS researchers will seek consent from participants randomised to the intervention to pass their contact details onto Incredible Years' delivery agents. Discussion: This feasibility study will inform the utility of the TwiCs approach within an experimental birth cohort to evaluate interventions for infants, toddlers, and their families. Trial registration: The study was prospectively registered on ISRCTN (ISRCTN16150114). [ABSTRACT FROM AUTHOR]

Background: The rising prevalence of adolescent mild depression in the UK and the paucity of evidence-based interventions in non-specialist sectors where most cases present, creates an urgent need for early psychological interventions. Randomised controlled trials (RCTs) are considered the gold standard for obtaining unbiased estimates of intervention effectiveness. However, the complexity of mental health settings poses great challenges for effectiveness evaluations. This paper reports learning from an embedded process evaluation of the ICALM RCT which tested the feasibility of delivering Interpersonal Counselling for Adolescents (IPC-A) plus Treatment as Usual (TAU) versus TAU only for adolescent (age 12–18) mild depression by non-qualified mental health professionals in non-specialist sectors. Methods: A qualitative mixed methods process evaluation, drawing on Bronfenbrenner's socioecological model to investigate key influences on trial delivery across macro-(e.g. policy), meso-(e.g. service characteristics) and micro-(e.g. on-site trial processes) contextual levels. Data collection methods included 9 site questionnaires, 4 observations of team meetings, policy documents, and 18 interviews with stakeholders including therapists, heads of service and managers. Thematic analysis focused on understanding how contextual features shaped trial implementation. Results: The ICALM trial concluded in 2022 having only randomised 14 out of the target 60 young people. At a macro-level, trial delivery was impacted by the COVID-19 pandemic, with services reporting a sharp increase in cases of (social) anxiety over low mood, and backlogs at central referral points which prolonged waiting times for mild cases (e.g. low mood). An interaction between high demand and lack of capacity at a meso-service level led to low prioritisation of trial activities at a micro-level. Unfamiliarity with research processes (e.g. randomisation) and variation in TAU support also accentuated the complexities of conducting an RCT in this setting. Conclusions: Conducting a RCT of IPC-A in non-specialist services is not feasible in the current context. Failure to conduct effectiveness trials in this setting has clinical implications, potentially resulting in escalation of mild mental health problems. Research done in this setting should adopt pragmatic and innovative recruitment and engagement approaches (e.g. creating new referral pathways) and consider alternative trial designs, e.g. cluster, stepped-wedge or non-controlled studies using complex systems approaches to embrace contextual complexity. Trial registration: ISRCTN registry, ISRCTN82180413. Registered on 31 December 2019. [ABSTRACT FROM AUTHOR]

Introduction: Nutrition-related factors linked to pain chronicity and disability include weight status and dietary behaviours. Dietary patterns associated with concurrent pain episodes, however, remain poorly characterised. This paper outlines the protocol for a feasibility study that aims to characterise pain-related dietary and lifestyle behaviours in people experiencing chronic musculoskeletal pain. Methods: The study will recruit participants who experience musculoskeletal pain on 5 or more days of the week for at least 3 months. Participants will attend two in-person clinic visits where physical measurements and a series of pain and lifestyle questionnaires will be completed. Visits will be conducted pre and post a 2-week self-monitoring period where participants will self-report concurrent diet, sleep, mood, and pain on four days and will wear a wrist-worn activity monitor (GENEActiv). Key feasibility metrics will evaluate participant recruitment, enrolment and retention rates, and compliance with the study data collection protocol. Discussion: There remains a lack of evidence behind dietary advice as an adjunct pain management tool. Upon completion of the protocol, feasibility outcomes will identify challenges to guide the design and delivery of a dietary intervention for chronic musculoskeletal pain. [ABSTRACT FROM AUTHOR]

Background: Pediatric brain tumor survivors (PBTS) are at risk of physical, cognitive, and psychosocial challenges related to their diagnosis and treatment. Routine follow-up care as adults is therefore essential to their long-term health and quality of life. In order to successfully navigate to adult healthcare, it is recommended that youth develop transition readiness skills. Existing transition readiness interventions often focus on disease management. However, PBTS are also at risk of social competence and cognitive functioning challenges. In this paper, we describe the protocol of this pilot study and the methodology that will be used for the evaluation of the feasibility, acceptability, and preliminary efficacy testing of the first targeted transition intervention workshops specifically designed to meet the needs of PBTS and their caregivers. Methods: This study will use a mixed method to evaluate three 1 ½-h workshops targeted for dyads (N = 40) of PBTS (14 years or older) and their parents. Dyads will be recruited via a community pediatric cancer organization and the long-term follow-up clinic of a large pediatric hospital. Participants will complete an online survey which includes the Transition Readiness Assessment Questionnaire (TRAQ) before and after the workshops. Each workshop will cover a specific topic related to PBTS transition readiness: disease management, social competence, and cognitive functioning. Workshops will follow the same structure: topic presentation, discussion by a post-transfer survivor or parent, teaching two strategies, and workshop evaluation. Workshops will be co-led by healthcare specialists and patient partners. Feasibility and acceptability will be assessed via recruitment, attendance, retention, and Likert scales, and they will be analyzed by describing and comparing rates. Satisfaction will be measured using satisfaction surveys and audio-recorded focus groups. Qualitative data will be described through thematic content analysis. In order to test the preliminary efficacy of this study, we will compare transition readiness skills pre- and post-workshops using paired samples T test and ANCOVA to examine the impact of workshop on TRAQ skills. Discussion: Results of the study will inform refinement and future broader implementation of targeted transition readiness workshops for the specific needs of pediatric brain tumor survivors. [ABSTRACT FROM AUTHOR]

Background: About 69% of Americans living with spinal cord injury (SCI) suffer from long-term debilitating neuropathic pain, interfering with the quality of daily life. Neuropathic pain is refractory to many available treatments—some carrying a risk for opioid addiction—highlighting an urgent need for new treatments. In this study, we will test our hypothesis that Spring Forest Qigong™ will reduce SCI-related neuropathic pain by improving body awareness. We will determine whether remotely delivered Qigong is feasible and we will collect data on neuropathic pain, and other reported associations with pain such as spasms frequency and/or severity, functional performance, mood, and body awareness. Methods: In this quasi-experimental pilot clinical trial study, adults with SCI will practice Qigong at home with a 45-min video, at least 3 × /week for 12 weeks. The Qigong practice includes movements with guided breathing and is individualized based on functional abilities, i.e., the participants follow along with the Qigong movements to the level of their ability, with guided breathing, and perform kinesthetic imagery by focusing on the feeling in the whole body as if doing the whole-body Qigong movement while standing. The highest, average, and lowest neuropathic pain ratings perceived in the prior week will be recorded weekly until the 6-week follow-up. The other outcomes will be collected at 5 time points: at baseline, midway during the Qigong intervention (6 weeks), after the Qigong intervention (12 weeks), after a 6-week and 1-year follow-up. Rate parameters for the feasibility markers will be estimated based on the participants who achieved each benchmark. Discussion: The University of Minnesota (UMN)'s Institutional Review Board (IRB) approved the study (IRB #STUDY00011997). All participants will sign electronic informed consent on the secure UMN REDCap platform. The results will be presented at academic conferences and published in peer-reviewed publications. Trial registration: ClinicalTrial.gov registration number: NCT04917107, (this protocol paper refers to the substudy), first registered 6/8/2021. [ABSTRACT FROM AUTHOR]

Background: This paper describes the protocol for the Nano X Image Guidance (Nano X IG) trial, a single-institution, clinical imaging study. The Nano X is a prototype fixed-beam radiotherapy system developed to investigate the feasibility of a low-cost, compact radiotherapy system to increase global access to radiation therapy. This study aims to assess the feasibility of volumetric image guidance with cone beam computed tomography (CBCT) acquired during horizontal patient rotation on the Nano X radiotherapy system. Methods: In the Nano X IG study, we will determine whether radiotherapy image guidance can be performed with the Nano X radiotherapy system where the patient is horizontally rotated while scan projections are acquired. We will acquire both conventional CBCT scans and Nano X CBCT scans for 30 patients aged 18 and above and receiving radiotherapy for head/neck or upper abdomen cancers. For each patient, a panel of experts will assess the image quality of Nano X CBCT scans against conventional CBCT scans. Each patient will receive two Nano X CBCT scans to determine the image quality reproducibility, the extent and reproducibility of patient motion and assess patient tolerance. Discussion: Fixed-beam radiotherapy systems have the potential to help ease the current shortfall and increase global access to radiotherapy treatment. Advances in image guidance could facilitate fixed-beam radiotherapy using horizontal patient rotation. The efficacy of this radiotherapy approach is dependent on our ability to image and adapt to motion due to rotation and for patients to tolerate rotation during treatment. Trial registration: ClinicalTrials.gov, NCT04488224. Registered on 27 July 2020. [ABSTRACT FROM AUTHOR]

Background: Exposure to secondhand tobacco smoke (SHS) and child maltreatment are preventable threats to child health. Few evidence-based interventions target both SHS and child maltreatment risk. The purpose of this paper is to describe the systematic braiding process of two evidence-based programs to address child SHS in the home and maltreatment perpetration risk, and present results from the formative work and pilot study. Methods: The first 4 steps of the systematic braiding process were completed, including the following: (1) the identification of core elements of both programs, (2) the development of an initial draft of the braided curriculum (Smoke-Free Home SafeCare — SFH-SC), (3) an acceptability and feasibility pilot of SFH-SC with caregivers of young children who reported a smoker living in the home (N = 8), and (4) feedback collection on the braided curriculum from SafeCare Providers (N = 9). Results: Experts identified common pedagogical and theoretical underpinnings for the two programs and braided Smoke-Free Homes: Some Things Are Better Outside into two SafeCare modules. Caregiver feedback from the pilot demonstrated that participants were engaged with SFH-SC and felt supported and comfortable discussing SHS intervention content with the SFH-SC Provider. Caregiver self-reports indicated a slight increase in smoke-free home rules from baseline to follow-up and a notable reduction in parent stress on the Parent Stress Index of 5.9 points (SD = 10.2). SafeCare Provider feedback following intensive review of the curriculum indicated high feasibility for SFH-SC delivery. Conclusions: Parent and Provider findings suggest SFH-SC is a viable intervention that has potential to reduce the public health impact of SHS and child maltreatment for at-risk families. Protocol: The protocol for the pilot is not published elsewhere; however, the full protocol for the hybrid trial can be found here: https://clinicaltrials.gov/ct2/show/NCT05000632. Trial registration: NCT, NCT05000632. Registered 14 July 2021, there is not a separate registration number for the pilot. [ABSTRACT FROM AUTHOR]

Background: In 2020, 1.4 and 2.3 million new cases of prostate cancer and breast cancer respectively were diagnosed globally. In the UK, prostate cancer is the most common male cancer, while breast cancer is the most common female cancer. Engaging in physical activity (PA) is a key component of treatment. However, rates of PA are low in these clinical populations. This paper describes the protocol of CRANK-P and CRANK-B, two pilot randomised controlled trials, involving an e-cycling intervention aimed at increasing PA in individuals with prostate cancer or breast cancer respectively. Methods: These two trials are single-centre, stratified, parallel-group, two-arm randomised waitlist-controlled pilot trials in which forty individuals with prostate cancer (CRANK-P) and forty individuals with breast cancer (CRANK-B) will be randomly assigned, in a 1:1 allocation ratio, to an e-cycling intervention or waitlist control. The intervention consists of e-bike training with a certified cycle instructor, followed by the provision of an e-bike for 12 weeks. Following the intervention period, participants in the e-bike condition will be directed to community-based initiatives through which they can access an e-bike. Data will be collected at baseline (T0), immediately post intervention (T1) and at 3-month follow-up (T2). In addition, in the intervention group, data will be collected during the intervention and follow-up periods. Quantitative and qualitative methods will be used. The primary objectives are to determine effective recruitment strategies, establish recruitment and consent rates, adherence and retention in the study, and determine the feasibility and acceptability of the study procedures and intervention. The potential impact of the intervention on clinical, physiological and behavioural outcomes will be assessed to examine intervention promise. Data analyses will be descriptive. Discussion: The findings from these trials will provide information on trial feasibility and highlight the potential of e-cycling as a strategy to positively impact the health and behaviour of individuals with prostate cancer and breast cancer. If appropriate, this information can be used to design and deliver a fully powered definitive trial. Trial registration: CRANK-B: [ISRCTN39112034]. CRANK-P [ISRCTN42852156]. Registered [08/04/2022] https://www.isrctn.com. [ABSTRACT FROM AUTHOR]

In 2016, we published a conceptual framework outlining the conclusions of our work in defining pilot and feasibility studies. Since then, the CONSORT extension to randomised pilot and feasibility trials has been published and there have been further developments in the pilot study landscape. In this paper, we revisit and extend our framework to incorporate the various feasibility pathways open to researchers, which include internal pilot studies. We consider, with examples, when different approaches to feasibility and pilot studies are more effective and efficient, taking into account the pragmatic decisions that may need to be made. The ethical issues involved in pilot studies are discussed. We end with a consideration of the funders' perspective in making difficult resource decisions to include feasibility work and the policy implications of these; throughout, we provide examples of the uncertainties and compromises that researchers have to navigate to make progress in the most efficient way. [ABSTRACT FROM AUTHOR]

Background: Dental caries is common in young people and has wide-ranging ramifications for health and quality of life. Text messaging interventions show promise as a means to promote oral health behaviour change among young people. This paper reports the internal pilot of the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial, which is evaluating an intervention comprising an oral health classroom lesson and text messages about toothbrushing, on caries in young people. Pilot trial objectives were to evaluate the feasibility and appropriateness of recruitment and data collection methods, the randomisation strategy, and intervention delivery against progression criteria for the main trial. Methods: This is an internal pilot trial embedded within an assessor-blinded, two-arm, cluster randomised controlled trial. Participants were pupils aged 11–13 years (in year 7/S1 or year 8/S2) in secondary schools in England, Scotland, and Wales with above average pupil eligibility for free school meals. Following completion of pupil baseline questionnaires and dental assessments, year groups within schools were randomised to the intervention or control arm. Approximately 12 weeks later, participants completed a follow-up questionnaire, which included questions about sources of oral health advice to assess intervention contamination between year groups. At the end of the pilot phase, trial conduct was reviewed against pre-specified progression criteria. Results: Ten schools were recruited for the pilot, with 20 year groups and 1073 pupils randomised (average of 54 pupils per year group). Data collection methods and intervention delivery were considered feasible, the response rate to the follow-up questionnaire was over 80%, there was an indication of a positive effect on self-reported toothbrushing, and interest was obtained from 80% of the schools required for the main trial. Despite partial intervention contamination between year groups, within-school randomisation at the level of the year-group was considered appropriate for the main trial, and the sample size was revised to account for partial contamination. Facilitators and barriers to recruitment and data collection were identified and strategies refined for the main trial. Conclusions: Progression to the main trial of BRIGHT, with some design refinements, was concluded. The internal pilot was an efficient way to determine trial feasibility and optimise trial processes. Trial registration: ISRCTN registry, ISRCTN12139369, registered 10/05/2017 [ABSTRACT FROM AUTHOR]

Background: The Harambee study is a cluster randomized trial in Western Kenya that tests the effect, mechanisms, and cost-effectiveness of integrating community-based HIV and non-communicable disease care within microfinance groups on chronic disease treatment outcomes. This paper documents the stages of our feasibility study conducted in preparation for the Harambee trial, which include (1) characterizing the target population and gauging recruitment capacity, (2) determining community acceptability of the integrated intervention and study procedures, and (3) identifying key implementation considerations prior to study start. Methods: Feasibility research took place between November 2019 and February 2020 in Western Kenya. Mixed methods data collection included surveys administered to 115 leaders of 105 community-based microfinance groups, 7 in-person meetings and two workshops with stakeholders from multiple sectors of the health system, and ascertainment of field notes and geographic coordinates for group meeting locations and HIV healthcare facilities. Quantitative survey data were analyzed using STATA IC/13. Longitude and latitude coordinates were mapped to county boundaries using Esri ArcMap. Qualitative data obtained from stakeholder meetings and field notes were analyzed thematically. Results: Of the 105 surveyed microfinance groups, 77 met eligibility criteria. Eligible groups had been in existence from 6 months to 18 years and had an average of 22 members. The majority (64%) of groups had at least one member who owned a smartphone. The definition of "active" membership and model of saving and lending differed across groups. Stakeholders perceived the community-based intervention and trial procedures to be acceptable given the minimal risks to participants and the potential to improve HIV treatment outcomes while facilitating care integration. Potential challenges identified by stakeholders included possible conflicts between the trial and existing community-based interventions, fear of group disintegration prior to trial end, clinicians' inability to draw blood for viral load testing in the community, and deviations from standard care protocols. Conclusions: This study revealed that it was feasible to recruit the number of microfinance groups necessary to ensure that our clinical trial was sufficient powered. Elicitation of stakeholder feedback confirmed that the planned intervention was largely acceptable and was critical to identifying challenges prior to implementation. Trial registration: The original trial was prospectively registered with ClinicalTrials.gov (NCT04417127) on 4 June 2020. [ABSTRACT FROM AUTHOR]

Background: Bronchopulmonary dysplasia (BPD) is a chronic disease that affects the immature lungs of preterm infants. Infants born before 32 weeks of gestation are at a greater risk of developing BPD due to the need for respiratory support with higher oxygen requirement. Pulmonary vascular remodelling in early BPD can impose an additional burden on the right ventricle (RV) and RV dysfunction. This protocol outlines the study design and aims to formulate a prediction model to identify early BPD through the data generated from echo scans analysis. Methods: The mixed-methods observational cohort feasibility study, which comprises three work-packages (WPs), will be conducted at the regional neonatal unit, University Hospital Plymouth, Plymouth, UK. WP-I will recruit 40 preterm infants; each participant will have two heart scans performed in the first ten days after birth (DABs). WP-II will collect the documentation of the participating preterm infants' parents in the study neonatal unit diaries in the first 10 DABs. WP-III will involve semi-structured interviews of 10–15 parents of participating preterm infants and 10–15 health professionals who participated in WP-I. The study recruitment will be conducted over 18-months. The start date is 01 June 2022. WP-I and WP-II recruitment will occur during this period, while WP-III recruitment will occur during the second half. The results are expected to be submitted for publication by mid-2024. Discussion: This paper outlines the study design. If the study successfully identifies the most sensitive echo parameter in recognising the RV dysfunction associated with early BPD, it will be an important finding in constructing an early BPD prediction model. Trial registration: ClinicalTrials.gov Identifier is NCT05235399 [ABSTRACT FROM AUTHOR]

Background : Sedentary behaviour among stroke inpatients may be due to high rates of depressive symptoms after stroke. Thus, efforts to address depressive symptoms among stroke inpatients are warranted to in turn lessen sedentary behaviour. Despite evidence that virtual reality (VR) is emerging as a method to help with depression, the use of VR to improve depression among inpatient stroke survivors has yet to be studied. In this paper, we report on the protocol investigating the feasibility of a VR entertainment system at improving depressive symptoms among stroke survivors receiving inpatient rehabilitation. Methods: In this single-blind randomized controlled trial, 30 inpatient stroke survivors from the rehabilitation unit at Kelowna General Hospital will be randomized to either (1) intervention: 3 times per week of VR entertainment for duration of inpatient rehabilitation or (2) control: usual care. Individuals will be included if they have a confirmed diagnosis of stroke, are 19 years of age or older, able to provide informed consent, have physician clearance to participate in the study (medically stable or fit), or are able to understand English. Outcome measures to address depressive symptoms (primary outcome), sedentary behaviour, motivation, anxiety, stress, and happiness (secondary outcome) will be administered at two timepoints: (1) baseline (T1) and (2) post-intervention (T2). Study analyses will consider study feasibility indicators and clinical (statistical) outcomes. Means and standard deviations (for continuous variables) and frequencies and proportions (for categorical variables) will be used to summarize the variables. Feasibility indicators will be dichotomized into either 'success' if they meet the a priori criteria, or 'revise' if they do not meet the criteria. Intervention effects post-intervention (T2) for the primary and secondary clinical outcomes will be estimated using linear regression including baseline (T1) controlling for age and sex. Discussion: The results of this trial will add to our understanding of depression and sedentary behaviour among individuals receiving inpatient stroke rehabilitation as well as the feasibility of a VR entertainment program to improve depressive symptoms, which will in turn may lessen sedentary behaviour in inpatient stroke survivors. Trial registration: ClinicalTrials.gov Identifier: NCT04011202. First posted July 8, 2019 (study postponed from March 2020 to July 2021 due to COVID-19). [ABSTRACT FROM AUTHOR]

Background: In rural areas, epilepsy patients have limited access to specialist secondary care. Substantial travel and waiting times of several hours are common. Communication between general practitioners (GP) and specialist epileptologists regarding diagnosis and treatment is further complicated by the high workload on both sides and the different prioritisation of treatment goals. This study aims to investigate the feasibility of an interprofessional audiovisual patient-doctor teleconsultation, and its acceptance in clinical practice in patients with epilepsy in a rural region in Germany. Method: Ten patients participated in telemedicine consultations in their GP practice. The practice was located in a sparsely populated region of Mecklenburg-Western Pomerania, and was equipped with technical equipment specifically procured for the project. An explorative qualitative interview was conducted with all participants. We based this paper on the consolidated criteria for reporting qualitative research (COREQ). Results: Despite initial uncertainties on the patients' side regarding the consultation setting, all participants found the teleconsultation helpful. Some patients were initially intimidated and felt slightly overwhelmed by the attention provided and the technology used (multiple HD cameras, large high-resolution screens). However, during the consultation, they felt supported by their GP and were satisfied that their needs were addressed in an appropriate and timely manner. The hardware used was not felt to be a nuisance or to interfere with the conversation between doctor and patient. Patients also appreciated the time saved and the organisational convenience compared to a visit to a university outpatient clinic. Most consultations led to therapeutic consequences. Some patients seemed to benefit particularly, for example those who needed a medication change. Conclusion: This pilot study provides first evidence that teleconsultations between patients, specialists, and GPs are possible in rural areas. Interprofessional collaboration between GPs and epileptologists can improve the care of patients with epilepsy. Further research should investigate the effectiveness and efficiency of interprofessional telemedicine consultations for epilepsy and other conditions. [ABSTRACT FROM AUTHOR]

Background: The cost of sickness absence has major social, psychological and financial implications for individuals and organisations. Return-to-work (RTW) interventions that support good quality communication and contact with the workplace can reduce the length of sickness absence by between 15 and 30 days. However, initiatives promoting a sustainable return to work for workers with poor mental health on long-term sickness absence across small, medium and large enterprises (SMEs and LEs) are limited. This paper describes the protocol of a pilot randomised controlled trial (RCT) to test the feasibility of implementing a RTW intervention across SMEs and LEs across all sectors. Methods and design: A two-arm feasibility RCT with a 4-month intervention will be conducted in SMEs and LE enterprises from the Midlands region, UK. At least 8 organisations (4 controls and interventions), and at least 60 workers and/or managers, will be recruited and randomised into the intervention and control group (30 interventions, 30 controls). Workers on long-term sickness absence (LTSA) (between 8 and 50 days) and managers with a worker on LTSA will be eligible to participate. The intervention is a behavioural change programme, including a managers and workers RTW toolkit, focused on supporting sickness absence and RTW through the provision of knowledge, problem-solving, action planning, goal setting and positive communication that leads to a sustainable RTW. Organisations assigned to the control group will continue with their usual practice. Measurements of mental health, RTW, work outcomes, quality-of-life, workplace support and communication and other demographic data will be taken at baseline, 2 months and 4 months. Feasibility will be assessed based on recruitment, retention, attrition, completion of measures and intervention compliance for which specific process and research outcomes have been established. A process evaluation will explore the experiences and acceptability of the intervention components and evaluation measures. Exploratory economic evaluation will be conducted to further inform a definitive trial. Discussion: This is a novel intervention using a worker-manager approach to promote a sustainable return to work of workers on long-term sick leave due to poor mental wellbeing. If this intervention is shown to be feasible, the outcomes will inform a larger scale randomised control trial. Trial registration: ISRCTN90032009 (retrospectively registered, date registered 15th December 2020) [ABSTRACT FROM AUTHOR]

Objectives: To outline the planning, development and optimisation of a psycho-educational behavioural intervention for patients on active surveillance for prostate cancer. The intervention aimed to support men manage active surveillance-related psychological distress. Methods: The person-based approach (PBA) was used as the overarching guiding methodological framework for intervention development. Evidence-based methods were incorporated to improve robustness. The process commenced with data gathering activities comprising the following four components: • A systematic review and meta-analysis of depression and anxiety in prostate cancer • A cross-sectional survey on depression and anxiety in active surveillance • A review of existing interventions in the field • A qualitative study with the target audience The purpose of this paper is to bring these components together and describe how they facilitated the establishment of key guiding principles and a logic model, which underpinned the first draft of the intervention. Results: The prototype intervention, named PROACTIVE, consists of six Internet-based sessions run concurrently with three group support sessions. The sessions cover the following topics: lifestyle (diet and exercise), relaxation and resilience techniques, talking to friends and family, thoughts and feelings, daily life (money and work) and information about prostate cancer and active surveillance. The resulting intervention has been trialled in a feasibility study, the results of which are published elsewhere. Conclusions: The planning and development process is key to successful delivery of an appropriate, accessible and acceptable intervention. The PBA strengthened the intervention by drawing on target-user experiences to maximise acceptability and user engagement. This meticulous description in a clinical setting using this rigorous but flexible method is a useful demonstration for others developing similar interventions. Trial registration and Ethical Approval: ISRCTN registered: ISRCTN38893965. NRES Committee South Central – Oxford A. REC reference: 11/SC/0355 [ABSTRACT FROM AUTHOR]

Background: Motor dysfunctions, such as slower walking speed, precede the occurrence of dementia and mild cognitive impairment, suggesting that walking parameters are effective biomarkers for detecting early sub-clinical cognitive risk. It is often also concurrent with self-complained cognitive dysfunction, called motoric cognitive risk (MCR) syndrome. Our preliminary study found several walking parameters, obtained by a three-dimensional motion capture system, to be correlated with computer-based assessments of various cognitive function modalities, although the sample size was small. The Cognitive-Gait (CoGait) Database Project, described in the current protocol, aims to establish a database of multi-dimensional walking and cognitive performance data, collected from a large sample of healthy participants, crucial for detecting early sub-clinical cognitive risk. Methods: We will recruit healthy volunteers, 20 years or older, without any neurological musculoskeletal or psychiatric disorders. The estimated sample size is 450 participants, including a 10% attrition rate. Using computer-based cognitive assessments, participants will perform six tasks: (i) the simple reaction time task, (ii) Go/No-Go task, (iii) Stroop Color–Word Test, (iv) N-back test, (v) Trail Making Test, and (vi) digit span test. We will also conduct paper-based cognitive assessments such as the Mini-Mental State Examination, Montreal Cognitive Assessment, and the Geriatric Depression Scale-15 for assessing MCR. Gait will be measured through joint kinematics and global positioning in participants' lower legs while walking at a comfortable and faster pace, using pants with an inertial measurement unit-based three-dimensional motion capture system. Finally, we will establish a prediction model for various cognitive performance modalities based on walking performance. Discussion: This will be the first study to reveal the relationship between walking and cognitive performance using multi-dimensional data collected from a large sample of healthy adults, from the general population. Despite certain methodological limitations such as the accuracy of measurements, the CoGait database is expected to be the standard value for both walking and cognitive functions, supporting the evaluation of psychomotor function in early sub-clinical cognitive risk identification, including motoric-cognitive risk syndrome. [ABSTRACT FROM AUTHOR]

Background: Health and social service providers receive limited education on recognizing and responding to family violence. With adequate education, providers could be prepared to identify individuals subjected to family violence and help reduce the risk of associated impairment. Informed by the Active Implementation Frameworks, our research will determine the scope of strategies needed for the uptake and sustainability of educational interventions focused on family violence for providers. It will also determine the acceptability, feasibility, and proof-of-concept for a new educational intervention, called VEGA (Violence, Evidence, Guidance, Action), for developing and improving primary care provider knowledge and skills in family violence. Methods: This paper details the protocol for the Researching the Impact of Service provider Education (RISE) Project. The RISE Project follows a sequential multiphase mixed method research design; qualitative and quantitative data are being collected and integrated over three conceptually and methodologically linked research phases. Activities primarily occur in Ontario, Alberta, and Quebec. Phase 1 uses a sequential exploratory mixed method research design to characterize the scope and salience of learning and implementation needs and preferences for family violence education. Phase 2 will use an embedded mixed method research design to determine whether VEGA technology supports providers to achieve their family violence learning goals with effectiveness, efficiency, and satisfaction. Phase 3 will use a concurrent mixed method research design to determine acceptability, feasibility, and proof-of-concept for evaluating whether VEGA improves primary care providers' knowledge and skills in family violence. This final phase will provide information on implementation strategies for family violence education in the "real world." It will also generate data on provider recruitment, retention, and data completeness, as well as exploratory estimates of the effect for provider outcome measures proposed for a randomized controlled trial. Discussion: The RISE Project comprehensively integrates an implementation approach to improve family violence education for the health and social service professions. It will provide important information about factors that could influence the uptake and effectiveness of a health profession's educational intervention into the real world, as well as provide foundational evidence concerning the tenability of using a randomized controlled trial to evaluate the impact of VEGA in primary care settings. [ABSTRACT FROM AUTHOR]

Background: The last 20 years have seen a marked increase in the use of cluster randomised trials (CRTs) in schools to evaluate interventions for improving pupil health outcomes. Schools have limited resources and participating in full-scale trials can be challenging and costly, given their main purpose is education. Feasibility studies can be used to identify challenges with implementing interventions and delivering trials. This systematic review summarises methodological characteristics and objectives of school-based cluster randomised feasibility studies in the United Kingdom (UK). Methods: We systematically searched MEDLINE from inception to 31 December 2020. Eligible papers were school-based feasibility CRTs that included health outcomes measured on pupils. Results: Of 3285 articles identified, 24 were included. School-based feasibility CRTs have been increasingly used in the UK since the first publication in 2008. Five (21%) studies provided justification for the use of the CRT design. Three (13%) studies provided details of a formal sample size calculation, with only one of these allowing for clustering. The median (IQR; range) recruited sample size was 7.5 (4.5 to 9; 2 to 37) schools and 274 (179 to 557; 29 to 1567) pupils. The most common feasibility objectives were to estimate the potential effectiveness of the intervention (n = 17; 71%), assess acceptability of the intervention (n = 16; 67%), and estimate the recruitment/retention rates (n = 15; 63%). Only one study was used to assess whether cluster randomisation was appropriate, and none of the studies that randomised clusters before recruiting pupils assessed the possibility of recruitment bias. Besides potential effectiveness, cost-effectiveness, and the intra-cluster correlation coefficient, no studies quantified the precision of the feasibility parameter estimates. Conclusions: Feasibility CRTs are increasingly used in schools prior to definitive trials of interventions for improving health in pupils. The average sample size of studies included in this review would be large enough to estimate pupil-level feasibility parameters (e.g., percentage followed up) with reasonable precision. The review highlights the need for clearer sample size justification and better reporting of the precision with which feasibility parameters are estimated. Better use could be made of feasibility CRTs to assess challenges that are specific to the cluster design. Trial registration: PROSPERO: CRD42020218993. [ABSTRACT FROM AUTHOR]

Introduction: Deaths from second-hand smoke (SHS) exposure are increasing, but there is not sufficient evidence to recommend a particular SHS intervention or intervention development approach. Despite the available guidance on intervention reporting, and on the role and nature of pilot and feasibility studies, partial reporting of SHS interventions is common. The decision-making whilst developing such interventions is often under-reported. This paper describes the processes and decisions employed during transitioning from the aim of adapting an existing mosque-based intervention focused on public health messages, to the development of the content of novel community-based Smoke-Free Home (SFH) intervention. The intervention aims to promote smoke-free homes to reduce non-smokers' exposure to SHS in the home via faith-based messages. Methods: The development of the SFH intervention had four sequential phases: in-depth interviews with adults in households in Dhaka, identification of an intervention programme theory and content with Islamic scholars from the Bangladesh Islamic Foundation (BIF), user testing of candidate intervention content with adults, and iterative intervention development workshops with Imams and khatibs who trained at the BIF. Results: It was judged inappropriately to take an intervention adaptation approach. Following the identification of an intervention programme theory and collaborating with stakeholders in an iterative and collaborative process to identify barriers, six potentially modifiable constructs were identified. These were targeted with a series of behaviour change techniques operationalised as Quranic verses with associated health messages to be used as the basis for Khutbahs. Following iterative user testing, acceptable intervention content was generated. Conclusion: The potential of this community-based intervention to reduce SHS exposure at home and improve lung health among non-smokers in Bangladesh is the result of an iterative and collaborative process. It is the result of the integration of behaviour change evidence and theory and community stakeholder contributions to the production of the intervention content. This novel combination of intervention development frameworks demonstrates a flexible approach that could provide insights for intervention development in related contexts. [ABSTRACT FROM AUTHOR]

Background: In psychological research, control conditions in the form of "treatment as usual" provide support for intervention efficacy, but do not allow the attribution of positive outcomes to the unique components of the treatment itself. Attentionally and structurally equivalent active control conditions, such as health education (HE), have been implemented in recent trials of cognitive behavioural therapy (CBT). However, descriptions and evaluations of these control conditions are limited. The aims of this paper were to (i) provide a detailed description and rationale for a novel HE active control condition and (ii) to evaluate the face validity, treatment integrity and feasibility of HE. Method: We developed a HE active control similar in structure and duration to a CBT intervention for reducing sleep disturbance and fatigue (CBT-SF) in a pilot randomised controlled trial (n = 51). Face validity was measured using post-treatment participant satisfaction and helpfulness ratings for fatigue and sleep symptoms, treatment fidelity was measured with integrity monitoring ratings from an independent expert and feasibility was measured with completion and attrition rates. HE and CBT-SF groups were compared using Wilcoxon rank-sum tests and chi-square tests of independence. Results: There were no significant differences in participant ratings of overall satisfaction between HE (n = 17) and CBT (n = 34) or in how helpful each intervention was for fatigue symptoms. Participants rated helpfulness for sleep symptoms higher in the CBT-SF group compared to HE. Integrity monitoring ratings were not significantly different for overall treatment delivery and therapist competency, but HE had greater module adherence than CBT-SF. There were no significant differences in completion or attrition rates between groups. Conclusion: Our findings suggest that the HE control had adequate face validity, was delivered with fidelity and was feasible and suitable for use as a comparator for CBT-SF. In providing a real-world example of practical and theoretical issues we considered when designing this control condition, we aim to provide a framework and guidance for future investigators. Trial registration: ACTRN12617000879369 (registered 15/06/2017) and ACTRN12617000878370 (registered 15/06/2017). [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease (CVD) is the most common cause of death among people with rheumatoid arthritis (RA), with an estimated increased risk of 50–60% compared to the general population. Lipid-lowering strategies have been shown to lower CVD risk significantly in people with RA and hyperlipidemia. Thus, CVD risk assessment has an important role to play in reducing CVD among people with RA. Yet currently only 37 to 45% of this population are receiving primary lipids screening. This paper describes the CArdiovascular Risk assEssment for RA (CARE RA) intervention, which is designed to address this issue. CARE RA is a peer coach intervention, that is, an intervention in which a person with RA coaches another person with RA, which is designed to educate people with RA about the relation between RA and CVD risk and to help them obtain evidence-based CVD risk assessment and treatment. Methods: This is an open-label pilot study that will test if the participants assigned to complete the CARE RA curriculum with a peer coach will receive a cardiovascular risk assessment more frequently compared to those that complete the CARE RA curriculum by themselves. The CARE RA intervention is guided by Social Cognitive Theory. Participants in the peer coach intervention arm will receive the assistance of a peer coach who will call the participants once a week for 5 weeks to go over the CARE RA curriculum and train them on how to obtain CVD risk assessment. The control arm will complete the CARE RA curriculum without any assistance. Participants will be randomized 1:1 either to the control arm or to the peer coach intervention arm. The primary outcome is a participant's having a CVD risk assessment or initiating a statin, if indicated. Secondary outcomes include patient activation and RA medication adherence. The RE-AIM implementation framework guides the implementation and evaluation of the intervention. Discussion: This pilot study will test the feasibility of the peer coach intervention in anticipation of a larger trial. CARE RA pioneers the use of peer coaches to facilitate the implementation of evidence-based treatment guidelines among people with RA. Trial registration: ClinicalTrials.gov NCT04488497. Registered on July 28, 2020. [ABSTRACT FROM AUTHOR]

Background: Cultural differences between health professionals and Indigenous peoples contribute to health inequalities, and effective cross-cultural communication and person-centred healthcare are critical remedial elements. Community pharmacists can play a significant role by reducing medication-related problems through medication reviews, yet barriers to access include cultural and linguistic challenges. The Indigenous Medication Review Service (IMeRSe) aimed to address these barriers via a culturally responsive intervention. The aim of this paper is to present the cross-cultural training framework developed as a component of this intervention and the feasibility evaluation of the first stage of the training framework. Methods: A training framework was developed, emphasising pharmacists' skills and confidence in effective cross-cultural communication and relationship-building with Indigenous Australians (Please note that the use of the term 'Indigenous' in this manuscript includes all Aboriginal and Torres Strait Islander people and acknowledges their rich traditions and heterogenous cultures) across three stages: (1) online and workshop-based, covering Indigenous history and health, cross-cultural communication and a holistic, strengths-based approach to intervention delivery; (2) orientation to local Aboriginal Health Services, community and cultural protocols; and (3) ongoing mentoring. The feasibility evaluation of the first stage included the following: self-reported levels of cultural capability, cultural confidence and skills, motivators and barriers to working with Indigenous Australians, assessed pre- and post-training. Participants completed self-administered questionnaires including a 22-item validated Cultural Capability Measurement Tool. Paired t tests assessed change in mean scores of Likert scale data. Results: Stage 1 development resulted in an 8.5-h standardised cross-cultural training programme tested with 39 pharmacists working across urban and rural/remote Australia. Thirty-six pharmacists completed the feasibility evaluation (75.7% female, all non-Indigenous, 75.7% never attended prior cross-cultural training). Participants reported overall acceptability with training; the majority perceived it added value to their practice. Improved cultural capability post-training was reflected in increased scores for 21/22 items, nine reaching statistical significance. There were significant improvements for all 26 confidence and skills statements, and selected motivational and barrier statements, particularly participants role in improving Indigenous health outcomes and cross-cultural communication. Conclusions: This study provides preliminary evidence that the training programme was feasible to deliver and prepared pharmacists to deliver a culturally responsive medication review intervention. The online knowledge-based modules and face-to-face workshops provide a standardised framework for larger-scale implementation of the intervention training. Trial registration: Australia and New Zealand Clinical Trials Registry ACTRN12618000188235.Prospectively registered 22 January 2018. [ABSTRACT FROM AUTHOR]

Background: "We Can Quit2" (WCQ2) was a pilot cluster randomised controlled trial with an embedded process evaluation assessing the feasibility and acceptability of 'We Can Quit' (WCQ, a peer-delivered community-based stop-smoking programme for women in disadvantaged communities. The control group comprised 'enhanced usual care' offered by the Irish Health Service Executive (HSE). The PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) is a tool to assess whether a trial design is more explanatory (working under ideal conditions) or pragmatic (working under 'real-world' conditions). The aim of this paper was to retrospectively evaluate the WCQ2 pilot trial using PRECIS-2 to inform the decision-making process on progression to a future definitive trial (DT). Methods: The WCQ2 trial protocol and HSE standard stop-smoking service were described across the nine PRECIS-2 domains: eligibility, recruitment, setting, organisation, flexibility-delivery, flexibility-adherence, follow-up and primary outcome. Team members scored the domains as pragmatic or explanatory for each arm in a half-day workshop. Results: Seven team members (practitioners and researchers) assessed the overall trial design as more explanatory than pragmatic. Important differences emerged between the two arms. WCQ targeted adult women from disadvantaged communities whereas HSE run a limited enhanced service for all quitters. Trial recruitment was challenging, intense efforts were needed as the trial proceeded. WCQ was delivered in a non-clinical community setting, HSE services in a clinical setting. WCQ organisation was co-designed with community partners and comprises peer-to-peer group support delivered by trained lay community facilitators, whereas HSE one-to-one support is delivered by Smoking Cessation Officers with a clinical background. Only WCQ allowed flexibility in delivery and adherence. Follow-up was more intensive in WCQ. Greater efforts to improve participant retention will be required in a future DT. Conclusions: PRECIS-2 allowed the reflection of practitioners and researchers on similarities and differences between intervention and control arms. Results will inform the decision on progression to an effectiveness DT, which will require more a pragmatic and less explanatory design. This novel use of PRECIS-2 to retrospectively evaluate a complex community-based pilot trial in advance of a full DT will also support learning for those undertaking hybrid trials of implementation and effectiveness. Trial registration: This trial is registered with the ISRCTN registry (No. 74721694). [ABSTRACT FROM AUTHOR]

Background: Due to the discreet and private nature of HIV self-testing (HIVST), it is particularly challenging to monitor and assess the impacts of this testing strategy. To overcome this challenge, we conducted a study in Côte d'Ivoire to characterize the profile of end users of HIVST kits distributed through the ATLAS project (AutoTest VIH, Libre d'Accéder à la connaissance de son Statut). Feasibility was assessed using a pilot phone-based survey. Methods: The ATLAS project aims to distribute 221300 HIVST kits in Côte d'Ivoire from 2019 to 2021 through both primary (e.g., direct distribution to primary users) and secondary distribution (e.g., for partner testing). The pilot survey used a passive recruitment strategy—whereby participants voluntarily called a toll-free survey phone number—to enrol participants. The survey was promoted through a sticker on the HIVST instruction leaflet and hotline invitations and informal promotion by HIVST kit-dispensing agents. Importantly, participation was not financially incentivized, even though surveys focussed on key populations usually use incentives in this context. Results: After a 7-month period in which 25,000 HIVST kits were distributed, only 42 questionnaires were completed. Nevertheless, the survey collected data from users receiving HIVST kits via both primary and secondary distribution (69% and 31%, respectively). Conclusion: This paper provides guidance on how to improve the design of future surveys of this type. It discusses the need to financial incentivize participation, to reorganize the questionnaire, the importance of better informing and training stakeholders involved in the distribution of HIVST, and the use of flyers to increase the enrolment of users reached through secondary distribution. [ABSTRACT FROM AUTHOR]

Background: Older adults frequently attend the emergency department (ED) and experience high rates of adverse outcomes following ED presentation including functional decline, ED re-presentation and unplanned hospital admission. The development of effective interventions to prevent such outcomes is a key priority for research and service provision. This paper reports a protocol designed to evaluate the feasibility of conducting a three arm randomised controlled trial (RCT) within the ED setting and in the patient's home. The interventions are comprehensive geriatric assessment (CGA), ED PLUS and usual care. Methods: The ED PLUS pilot trial is designed as a feasibility RCT conducted in the ED and Acute Medical Assessment Unit of a university teaching hospital in the mid-west region of Ireland. We aim to recruit 30 patients, aged 65 years and over presenting to the ED with undifferentiated medical complaints and discharged within 72 h of index visit. Patients will be randomised by a computer in a ratio of 1:1:1 to deliver usual care, CGA or ED PLUS during a 6-month study period. A randomised algorithm is used to perform randomization. CGA will include a medical assessment, medication review, nursing assessment, falls assessment, assessment of mobility and stairs, transfers, personal care, activities of daily living (ADLs), social supports and baseline cognition. ED PLUS, a physiotherapist led, multidisciplinary intervention, aims to bridge the transition of care between the index visit to the ED and the community by initiating a CGA intervention in the ED and implementing a 6-week follow-up self-management programme in the patient's own home following discharge from the ED. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively. Discussion: Rising ED visits and an ageing population with chronic health issues render ED interventions to reduce adverse outcomes in older adults a research priority. This feasibility RCT will generate data and experience to inform the conduct and delivery of a definite RCT. Trial registration: The trial was registered in Clinical Trials Protocols and Results System as of 21st July 2021, with registration number NCT049836020. [ABSTRACT FROM AUTHOR]

Background: Older adults frequently attend the emergency department (ED) and experience high rates of adverse outcomes following ED presentation including functional decline, ED re-presentation and unplanned hospital admission. The development of effective interventions to prevent such outcomes is a key priority for research and service provision. This paper reports a protocol designed to evaluate the feasibility of conducting a three arm randomised controlled trial (RCT) within the ED setting and in the patient's home. The interventions are comprehensive geriatric assessment (CGA), ED PLUS and usual care. Methods: The ED PLUS pilot trial is designed as a feasibility RCT conducted in the ED and Acute Medical Assessment Unit of a university teaching hospital in the mid-west region of Ireland. We aim to recruit 30 patients, aged 65 years and over presenting to the ED with undifferentiated medical complaints and discharged within 72 h of index visit. Patients will be randomised by a computer in a ratio of 1:1:1 to deliver usual care, CGA or ED PLUS during a 6-month study period. A randomised algorithm is used to perform randomization. CGA will include a medical assessment, medication review, nursing assessment, falls assessment, assessment of mobility and stairs, transfers, personal care, activities of daily living (ADLs), social supports and baseline cognition. ED PLUS, a physiotherapist led, multidisciplinary intervention, aims to bridge the transition of care between the index visit to the ED and the community by initiating a CGA intervention in the ED and implementing a 6-week follow-up self-management programme in the patient's own home following discharge from the ED. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively. Discussion: Rising ED visits and an ageing population with chronic health issues render ED interventions to reduce adverse outcomes in older adults a research priority. This feasibility RCT will generate data and experience to inform the conduct and delivery of a definite RCT. Trial registration: The trial was registered in Clinical Trials Protocols and Results System as of 21st July 2021, with registration number NCT049836020. [ABSTRACT FROM AUTHOR]

Background: People with severe mental illness (SMI) have an increased risk of premature mortality, predominantly due to somatic health conditions. Evidence indicates that primary and tertiary prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility of a coordinated co-produced care program (SOFIA model, a Danish acronym for Severe Mental Illness and Physical Health in General Practice) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. Methods: The SOFIA pilot trial is designed as a cluster randomized controlled trial targeting general practices in two regions in Denmark. We aim to include 12 practices, each of which is instructed to recruit up to 15 community-dwelling patients aged 18 and older with SMI. Practices will be randomized by a computer in a ratio of 2:1 to deliver a coordinated care program or usual care during a 6-month study period. A randomized algorithm is used to perform randomization. The coordinated care program includes educational training of general practitioners and their clinical staff educational training of general practitioners and their clinical staff, which covers clinical and diagnostic management and focus on patient-centered care of this patient group, after which general practitioners will provide a prolonged consultation focusing on individual needs and preferences of the patient with SMI and a follow-up plan if indicated. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively. Assessments of the outcome parameters will be administered at baseline, throughout, and at end of the study period. Discussion: If necessary the intervention will be revised based on results from this study. If delivery of the intervention, either in its current form or after revision, is considered feasible, a future, definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place. Successful implementation of the intervention would imply preliminary promise for addressing health inequities in patients with SMI. Trial registration: The trial was registered in Clinical Trials as of November 5, 2020, with registration number NCT04618250. Protocol version: January 22, 2021; original version [ABSTRACT FROM AUTHOR]

Background: Research consistently reports elevated rates of exposure to traumatic events and post-traumatic stress disorder (PTSD) in people with severe mental illness (SMI). PTSD may be adequately managed with psychotherapy; however, there is a gap when it comes to management in culturally diverse settings like Botswana. This paper describes a study protocol whose aim is to culturally adapt the BREATHE intervention, a brief psychological intervention for people living with comorbid PTSD and SMI that was developed and tested in the USA; assess the feasibility and acceptability of the adapted BREATHE intervention and explore its efficacy. Methods: The study will be conducted in three phases using a mixed methods approach. The first phase will identify and describe the most common traumatic experiences and responses to traumatic experiences, amongst patients with SMI, and patients' and mental health care providers' perceptions about suitable PTSD interventions for Botswana. The second phase will entail cultural adaption of the intervention using findings from phase 1, and the third phase will be a pilot trial to assess the feasibility and acceptability of the culturally adapted intervention and explore its efficacy. Quantitative and qualitative data will be analysed using basic descriptive statistics and thematic analysis, respectively. Discussion: Literature highlights cultural variations in the expression and management of mental illness suggesting the need for culturally adapted interventions. The findings of this feasibility study will be used to inform the design of a larger trial to assess the efficacy of an adapted brief intervention for PTSD in patients with SMI in Botswana. Trial registration: Clinicaltrials.gov registration: NCT04426448. Date of registration: June 7, 2020. [ABSTRACT FROM AUTHOR]

Background: By 2050, worldwide dementia prevalence is expected to triple. Affordable, scalable interventions are required to support protective behaviours such as physical activity, cognitive training and healthy eating. This paper outlines the theory-, evidence- and person-based development of 'Active Brains': a multi-domain digital behaviour change intervention to reduce cognitive decline amongst older adults. Methods: During the initial planning phase, scoping reviews, consultation with PPI contributors and expert co-investigators and behavioural analysis collated and recorded evidence that was triangulated to inform provisional 'guiding principles' and an intervention logic model. The following optimisation phase involved qualitative think aloud and semi-structured interviews with 52 older adults with higher and lower cognitive performance scores. Data were analysed thematically and informed changes and additions to guiding principles, the behavioural analysis and the logic model which, in turn, informed changes to intervention content. Results: Scoping reviews and qualitative interviews suggested that the same intervention content may be suitable for individuals with higher and lower cognitive performance. Qualitative findings revealed that maintaining independence and enjoyment motivated engagement in intervention-targeted behaviours, whereas managing ill health was a potential barrier. Social support for engaging in such activities could provide motivation, but was not desirable for all. These findings informed development of intervention content and functionality that appeared highly acceptable amongst a sample of target users. Conclusions: A digitally delivered intervention with minimal support appears acceptable and potentially engaging to older adults with higher and lower levels of cognitive performance. As well as informing our own intervention development, insights obtained through this process may be useful for others working with, and developing interventions for, older adults and/or those with cognitive impairment. [ABSTRACT FROM AUTHOR]

Background: Dizziness is a common complaint that often persists and leads to disability and distress. Several cognitive and behavioural responses may contribute to the neurobiological adaptations that maintain persistent vestibular symptoms. This paper will present the protocol of a two-arm parallel group feasibility randomised controlled trial designed to determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of an integrated cognitive behavioural therapy and vestibular rehabilitation (CBT-VR) treatment for people with persistent dizziness. Methods: Forty adult patients will be recruited from a tertiary vestibular clinic with persistent movement–triggered dizziness for 3 months or longer who have moderate–high levels of dizziness handicap. Participants will be 1:1 randomised, using a minimisation procedure, to six sessions of either CBT-VR (intervention arm) or VR only (control arm). Measures will be collected at baseline and 4 months post randomisation. The primary feasibility outcomes include descriptive data on numbers meeting eligibility criteria, rates of recruitment, numbers retained post randomisation, treatment adherence and an acceptability questionnaire. Treatment effects on self-report outcomes will be estimated to determine that 95% confidence intervals for the effects are consistent with anticipated effects and minimum clinically important differences, and to provide information needed for the power calculation of an efficacy trial. A nested qualitative study will be conducted post-intervention (intervention group only) to explore the acceptability of the intervention and identify any areas in need of improvement. Discussion: If a trial of CBT-VR is feasible, acceptability data will be used to enhance the intervention if needed and refine the multicentre RCT protocol. Future studies will need to consider the training required for other physiotherapists to deliver the intervention. Trial registration: ClinicalTrials.gov, ISRCTN 10420559 [ABSTRACT FROM AUTHOR]

Background: Freezing of gait (FOG) is a particularly debilitating motor deficit seen in a subset of Parkinson's disease (PD) patients that is poorly responsive to standard levodopa therapy or deep brain stimulation (DBS) of established PD targets such as the subthalamic nucleus and the globus pallidus interna. The proposal of a DBS target in the midbrain, known as the pedunculopontine nucleus (PPN) to address FOG, was based on its observed pathology in PD and its hypothesized involvement in locomotor control as a part of the mesencephalic locomotor region, a functionally defined area of the midbrain that elicits locomotion in both intact animals and decerebrate animal preparations with electrical stimulation. Initial reports of PPN DBS were met with much enthusiasm; however, subsequent studies produced mixed results, and recent meta-analysis results have been far less convincing than initially expected. A closer review of the extensive mesencephalic locomotor region (MLR) preclinical literature, including recent optogenetics studies, strongly suggests that the closely related cuneiform nucleus (CnF), just dorsal to the PPN, may be a superior target to promote gait initiation. Methods: We will conduct a prospective, open-label, single-arm pilot study to assess safety and feasibility of CnF DBS in PD patients with levodopa-refractory FOG. Four patients will receive CnF DBS and have gait assessments with and without DBS during a 6-month follow-up. Discussion: This paper presents the study design and rationale for a pilot study investigating a novel DBS target for gait dysfunction, including targeting considerations. This pilot study is intended to support future larger scale clinical trials investigating this target. Trial registration: ClinicalTrials.gov identifier: NCT04218526 (registered January 6, 2020) [ABSTRACT FROM AUTHOR]

Background: Children are vulnerable to the effects of second-hand smoke exposure. Creating smoke-free homes is an effective strategy to limit exposure. We developed a smoke-free intervention (SFI) using children as a catalyst for change and teaching skills to negotiate a smoke-free home. In this paper, we present the process evaluation conducted within a pilot trial. Methods: This was a mixed-methods study comprising qualitative interviews and quantitative fidelity assessment of SFI delivery. Interviews in the six intervention schools were conducted with six headteachers and 12 teachers. These explored experiences of delivering the SFI, perceived impact, barriers and facilitators to success, and ideas for improvement and for scaling up. The data were analysed using framework analysis. Delivery of the SFI was observed and fidelity scores calculated. Results: The SFI was acceptable to headteachers and teachers. Fidelity scores ranged from 27/40 to 37/40. Didactic components were more fully implemented than interactive components. Time to complete the sessions, timing in the school day and school calendar were key challenges. Embedding the SFI into the curriculum was a potential solution. Conclusions: These findings provide useful information to finalise the content and delivery and inform the scale-up of the SFI for our definitive trial, which is now underway. Trial registration: ISRCTN68690577 [ABSTRACT FROM AUTHOR]

Background: Falls prevention exercise programmes help to improve muscle strength, balance and physical function, and reduce falling rates in older adults. Improvements in muscle strength, balance and physical function are reversed if older adults do not continue to be physically active after falls prevention exercise programmes end. This paper describes the design process of an intervention that aimed to maintain physical activity in older adults exiting falls prevention exercise programmes. Methods: The development of the Keeping Adults Physically Active (KAPA) intervention and its implementation plan was guided by Bartholomew's Intervention Mapping approach. The intervention mapping approach involved (1) performing a needs assessment and developing intervention objectives using previous literature; (2) identifying theory-based intervention strategies from a systematic review and the National Institute of Clinical Excellence guidelines; and (3) designing the KAPA intervention and its implementation plan with the guidance from an expert steering group. Results: The KAPA intervention comprised of six group sessions of motivational interviewing, delivered monthly by trained and mentor-supported falls prevention practitioners. Intervention sessions lasted up to 90 min and were delivered in community settings over a 6-month duration. Participant manuals, illustrated exercise books, physical activity diaries and pedometers supported the KAPA intervention. Conclusions: The intervention development process, consisting of Bartholomew's Intervention Mapping approach and the input from an expert steering group, was successful in creating the evidence-based KAPA intervention ready to be evaluated in a feasibility trial. [ABSTRACT FROM AUTHOR]

Background: Home visiting is a well-supported strategy for addressing maternal and child health disparities. However, evidence-based models generally share implementation challenges at scale, including engagement and retention of families. Precision home visiting may address this issue. This paper describes the first known pilot randomized implementation trial of a precision home visiting approach vs. standard implementation. Primary aims are to: 1) explore the acceptability and feasibility of a precision approach to home visiting and 2) examine the difference between Standard Family Spirit and Precision Family Spirit on participants' program satisfaction, client-home visitor relationship, goal alliance, and the impact of these factors on participant engagement and retention. Secondary aims are to explore potential differences on maternal behavioral and mental health outcomes and child development outcomes to inform sample size estimations for a fully powered study. Methods: This is a pilot Hybrid Type 3 implementation trial. Four Michigan communities primarily serving the Native American families and already using Family Spirit were randomized by site to receive Standard Family Spirit or Precision Family Spirit. Participants include N = 60 mothers at least 14 years of age (pregnant or with a newborn < 2 months of age) currently enrolled in Family Spirit. Precision Family Spirit participants receive core lessons plus additional lessons based on needs identified at baseline and that emerge during the trial. Control mothers receive the standard sequence of Family Spirit lessons. Data is collected at baseline (< 2 months postpartum), and 2, 6, and 12 months postpartum. All Precision Family Spirit participants are invited to complete qualitative interviews at study midpoint and endpoint. All home visitors are invited to participate in focus groups between study midpoint and endpoint. Exploratory data analysis will assess feasibility, acceptability, client-home visitor relationship, retention, adherence, and potential differences in intervention outcomes. Discussion: This trial will provide new information about the acceptability and feasibility of precision home visiting and pilot data on program satisfaction, client-home visitor relationship, goal alliance, retention, and targeted maternal-child intervention outcomes. Findings will inform the design of a fully powered randomized implementation trial of precision vs. standard home visiting. Trial registration: ClinicalTrials.gov #NCT03975530; Registered on June 5, 2019 [ABSTRACT FROM AUTHOR]

Background: Cystic fibrosis (CF) is a life-limiting genetic condition in which daily therapies to maintain lung health are critical, yet treatment adherence is low. Previous interventions to increase adherence have been largely unsuccessful and this is likely due to a lack of focus on behavioural evidence and theory alongside input from people with CF. This intervention is based on a digital platform that collects and displays objective nebuliser adherence data. The purpose of this paper is to identify the specific components of an intervention to increase and maintain adherence to nebuliser treatments in adults with CF with a focus on reducing effort and treatment burden. Methods: Intervention development was informed by the Behaviour Change Wheel (BCW) and person-based approach (PBA). A multidisciplinary team conducted qualitative research to inform a needs analysis, selected, and refined intervention components and methods of delivery, mapped adherence-related barriers and facilitators, associated intervention functions and behaviour change techniques, and utilised iterative feedback to develop and refine content and processes. Results: Results indicated that people with CF need to understand their treatment, be able to monitor adherence, have treatment goals and feedback and confidence in their ability to adhere, have a treatment plan to develop habits for treatment, and be able to solve problems around treatment adherence. Behaviour change techniques were selected to address each of these needs and were incorporated into the digital intervention developed iteratively, alongside a manual and training for health professionals. Feedback from people with CF and clinicians helped to refine the intervention which could be tailored to individual patient needs. Conclusions: The intervention development process is underpinned by a strong theoretical framework and evidence base and was developed by a multidisciplinary team with a range of skills and expertise integrated with substantial input from patients and clinicians. This multifaceted development strategy has ensured that the intervention is usable and acceptable to people with CF and clinicians, providing the best chance of success in supporting people with CF with different needs to increase and maintain their adherence. The intervention is being tested in a randomised controlled trial across 19 UK sites. [ABSTRACT FROM AUTHOR]

Background: Balance, mobility impairments and falls are problematic for people with multiple sclerosis (MS). The "Balance Right in MS (BRiMS)" intervention, a 13-week home and group-based exercise and education programme, aims to improve balance and minimise falls. This study aimed to evaluate the feasibility of undertaking a multi-centre randomised controlled trial and to collect the necessary data to design a definitive trial. Methods: This randomised controlled feasibility study recruited from four United Kingdom NHS clinical neurology services. Patients ≥ 18 years with secondary progressive MS (Expanded Disability Status Scale 4 to 7) reporting more than two falls in the preceding 6 months were recruited. Participants were block-randomised to either a manualised 13-week education and exercise programme (BRiMS) plus usual care, or usual care alone. Feasibility assessment evaluated recruitment and retention rates, adherence to group assignment and data completeness. Proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls) and economic data were collected at baseline, 13 and 27 weeks, and participants completed daily paper falls diaries. Results: Fifty-six participants (mean age 59.7 years, 66% female, median EDSS 6.0) were recruited in 5 months; 30 randomised to the intervention group. Ten (18%) participants withdrew, 7 from the intervention group. Two additional participants were lost to follow up at the final assessment point. Completion rates were > 98% for all outcomes apart from the falls diary (return rate 62%). After adjusting for baseline score, mean intervention—usual care between-group differences for the potential primary outcomes at week 27 were MS Walking Scale-12v2: − 7.7 (95% confidence interval [CI] − 17.2 to 1.8) and MS Impact Scale-29v2: physical 0.6 (CI − 7.8 to 9), psychological − 0.4 (CI − 9.9 to 9). In total, 715 falls were reported, rate ratio (intervention:usual care) for falls 0.81 (0.41 to 2.26) and injurious falls 0.44 (0.41 to 2.23). Conclusions: Procedures were practical, and retention, programme engagement and outcome completion rates satisfied a priori progression criteria. Challenges were experienced in completion and return of daily falls diaries. Refinement of methods for reporting falls is therefore required, but we consider a full trial to be feasible. Trial registration: ISRCTN13587999 Date of registration: 29 September 2016 [ABSTRACT FROM AUTHOR]

Background: Effective translation of evidence-based research into clinical practice requires assessment of the many factors that can impact implementation success. Research methods that draw on recognised implementation frameworks, such as the Promoting Action Research in Health Services (PARiHS) framework, and that test feasibility to gain information prior to full-scale roll-out, can support a more structured approach to implementation. Objective: This paper presents qualitative findings from a feasibility study in one cancer service of an online portal to operationalise a clinical pathway for the screening, assessment and management of anxiety and depression in adult cancer patients. The aim of this study was to explore staff perspectives on the feasibility and acceptance of a range of strategies to support implementation in order to inform the full-scale roll-out. Methods: Semi-structured interviews were conducted with fifteen hospital staff holding a range of clinical, administrative and managerial roles, and with differing levels of exposure to the pathway. Qualitative data were analysed thematically, and themes were subsequently organised within the constructs of the PARiHS framework. Results: Barriers and facilitators that affected the feasibility of the online portal and implementation strategies were organised across eight key themes: staff perceptions, culture, external influences, attitudes to psychosocial care, intervention fit, familiarity, burden and engagement. These themes mapped to the PARiHS framework's three domains of evidence, context and facilitation. Conclusions: Implementation success may be threatened by a range of factors related to the real-world context, perceptions of the intervention (evidence) and the process by which it is introduced (facilitation). Feasibility testing of implementation strategies can provide unique insights into issues likely to influence full-scale implementation, allowing for early tailoring and more effective facilitation which may save time, money and effort in the long-term. Use of a determinant implementation framework can assist researchers to synthesise and effectively respond to barriers as they arise. While the current feasibility study related to a specific implementation, strategies such as regular engagement with local stakeholders, and discussion of barriers arising in real-time during early testing is likely to be of benefit to all researchers and clinicians seeking to maximise the likelihood of long-term implementation success. [ABSTRACT FROM AUTHOR]

Background: A stroke is a sudden, life-altering event with potentially devastating consequences for survivors and their loved ones. Despite advances in endovascular and neurocritical care approaches to stroke treatment and recovery, there remains a considerable unmet need for interventions targeting the emotional impact of stroke for both patients and their informal caregivers. This is important because untreated emotional distress becomes chronic and negatively impacts quality of life in both patients and caregivers. Our team previously used mixed methods to iteratively develop a six-session modular dyadic intervention to prevent chronic emotional distress in patients with stroke and their informal caregivers called "Recovering Together" (RT) using feedback from dyads and the medical team. The aim of the current study is to test the feasibility of recruitment, acceptability of screening and randomization methods, acceptability of RT, satisfaction with RT, feasibility of the assessment process at all time points, and acceptability of outcome measures. Secondarily, we aimed to explore within-treatment effect sizes and change in clinically significant symptoms of depression, anxiety, and post-traumatic stress (PTS). The larger goal was to strengthen methodological rigor before a subsequent efficacy trial. Methods: We conducted a feasibility randomized controlled trial to evaluate the RT intervention relative to minimally enhanced usual care (MEUC) in stroke patients admitted to a Neurosciences Intensive Care Unit (Neuro-ICU). Dyads were enrolled within 1 week of hospitalization if they met specific eligibility criteria. Assessments were done via paper and pencil at baseline, and electronically via REDCap or over the phone at post-intervention (approximately 6 weeks after baseline), and 3 months later. Assessments included demographics, resiliency intervention targets (mindfulness, coping, self-efficacy, and interpersonal bond), and emotional distress (depression, anxiety, and PTS). Primary outcomes were feasibility and acceptability markers. Secondary outcomes were depression, anxiety, PTS, mindfulness, coping, self-efficacy, and interpersonal bond. Results: We consented 20 dyads, enrolled 17, and retained 16. Although many patients were missed before we could approach them, very few declined to participate or dropped out once study staff made initial contact. Feasibility of enrollment (87% of eligible dyads enrolled), acceptability of screening, and randomization (all RT dyads retained after randomization) were excellent. Program satisfaction (RT post-test M = 11.33/12 for patients M = 12/12 for caregivers), and adherence to treatment sessions (six of seven RT dyads attending 4/6 sessions) were high. There were no technical difficulties that affected the delivery of the intervention. There was minimal missing data. For both patients and caregivers, participation in RT was generally associated with clinically significant improvement in emotional distress symptoms from baseline to post-test. Participation in MEUC was associated with clinically significant worsening in emotional distress. Although some of the improvement in emotional distress symptoms decreased in the RT group between post-test to 3 months, these changes were not clinically significant. RT was also associated with substantial decrease in frequency of individuals who met criteria for clinically significant symptoms, while the opposite was true for MEUC. There were many lessons that informed current and future research. Conclusions: This study provided evidence of feasibility and signal of improvement in RT, as well as necessary methodological changes to increase recruitment efficiency before the future hybrid efficacy-effectiveness trial. Trial registration: NCT02797509. [ABSTRACT FROM AUTHOR]

Background: Displaced victims of interpersonal violence, such as refugees, asylum seekers, and victims of sexual exploitation, are growing in numbers and are often suffering from a post-traumatic stress disorder (PTSD). At the same time, these victims are known to benefit less from trauma-focused therapy (TFT) and to be less compliant to treatment. The objective of this paper is to describe the rationale and research protocol of an ongoing trial that aims to evaluate different variables that might influence the feasibility of TFT for the study population. Specifically, perceived daily stress, emotion regulation, and mood are investigated as predictors of change in PTSD symptoms during a trauma-focused therapy (narrative exposure therapy (NET)). The feasibility of administering measures tapping these constructs repeatedly during treatment will also be evaluated. Methods/design: Using an observational treatment design, 80 displaced victims of interpersonal violence will be measured before, during, and after partaking in NET. Several questionnaires tapping PTSD plus the aforementioned possible predictors of PTSD change will be administered: Post-traumatic Stress Disorder Checklist-5, Perceived Stress Scale, Difficulties in Emotion Regulation Scale-18 (pre-test, post-test, and follow-up),subscale impulsivity of the Difficulties in Emotion Regulation Scale-18, Perceived Stress Scale short version, Primary Care Post-traumatic Stress Disorder and a single Mood item (each session). Multilevel modelling will be used to examine the relation between the possible predictors and treatment outcome. Discussion: The present study is the first to examine the interplay of facilitating and interfering factors possibly impacting treatment feasibility and effectiveness in displaced victims of interpersonal violence with PTSD receiving NET, using repeated measures. The current study can help to improve future treatment based on individual characteristics. Trial registration: Netherlands Trial Register: NTR7353, retrospectively registered. Date of registration: July 11, 2018. [ABSTRACT FROM AUTHOR]

Background: Physical inactivity and unhealthy eating are two leading behavioral risk factors contributing to preventable non-communicable diseases (NCDs). Evidence-based interventions (EBI) using community-engaged approaches to address these risks abound in high-income countries. Comparatively, evidence of such interventions is sparse in low- and middle-income countries, where NCD mortality is greater. This paper describes the protocol for the development of the cultural adaptation and pilot testing of a combination of two EBI (i.e., Body and Soul and the Healthy Body Healthy Spirit), in church-based settings in Lagos, Nigeria. In addition, we describe the development of the inclusion of an additional component, i.e., faith-based text messages, into one of the treatment arms. Our objective is to assess the feasibility of developing and implementing the adapted interventions with the ultimate aim of developing a fully powered trial. Methods: This pilot study will assess the design and implementation of a three-arm cluster-randomized pilot trial in 12 randomly selected Anglican churches (4 in each arm). First, we will design a cultural adaptation of the two EBI's to form a multifaceted combined intervention known as the Body Soul and Spirit. The second treatment arm, i.e., Body Soul and Spirit Plus, will retain all the components of Body Soul and Spirit with the inclusion of faith-based text messages using mobile phones. Participants in the control arm will receive information leaflets designed to increase physical activity and healthy food consumption. The outcome measures include participant recruitment and retention, program participation and satisfaction, and data collection completion rates. The outcomes for the proposed definitive trial will be the number of servings of fruit and vegetables and minutes of moderate to vigorous physical activity per day will be assessed at baseline, 3 and 6-month follow-up. Implementation outcomes will be assessed using qualitative and quantitative methods. Discussion: The study will enhance the understanding of how best to design and implement behavioral interventions in church-based settings using community-based participatory approaches. It will also inform the development of a definitive randomized controlled trial. Trial registration: Pan African Clinical Trials Registry on 12th July 2018. PACTR201807136835945. Available at https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3481 [ABSTRACT FROM AUTHOR]

Background: Untreated heterozygous familial hypercholesterolaemia (FH) causes high low-density lipoprotein cholesterol (LDL-C) levels and increased cardiovascular disease (CVD) risk. Despite pharmacological treatment, many treated individuals remain at higher CVD risk than non-affected individuals. This may be due to LDL-C targets not being met and presence of other CVD risk factors. Adhering to dietary and physical activity (PA) recommendations developed for individuals with FH may further reduce CVD risk. However, there is insufficient research to support the efficacy of adhering to these guidelines on LDL-C and other CVD risk factors. The need for studies to investigate the effectiveness of nutrition and PA interventions in the FH population has been widely recognised and recommended. This paper describes the protocol of a pilot, randomised controlled trial designed to evaluate the feasibility and acceptability of a specifically developed nutrition and PA intervention aimed at improving the dietary intakes and PA levels of families with FH. Methods: A two-arm randomised waitlist-controlled pilot trial will be conducted across three National Health Service (NHS) sites in England, UK. Twenty-four young people with FH, aged 10–18 years, and their affected parent, will be recruited and randomly assigned to the intervention or waitlist and usual care control. The primary aim is to provide evidence for the feasibility and acceptability of delivering the intervention, explored quantitatively (rates of recruitment, retention and outcome measure completeness) and qualitatively (qualitative interviews). The secondary aim is to provide evidence for the potential efficacy of the intervention on dietary intake, PA, sedentary time, body composition, CVD risk factors and quality of life determined at baseline and endpoint assessments. The intervention will involve an hour-long consultation with a dietitian at baseline and four follow-up contacts across the 12-week intervention. It has been specifically developed for use with individuals with FH and incorporates behavioural change techniques to target identified enablers and barriers to adherence in this population. Discussion: This trial will estimate the feasibility and acceptability of the nutrition and PA intervention delivered to young people and parents with FH. If appropriate, this study can be used to inform the design of an adequately powered definitive trial. Trial registration: ISRCTN, ISRCTN24880714. Registered 07/06/2018, http://www.isrctn.com/ISRCTN24880714. [ABSTRACT FROM AUTHOR]

Background: Malnutrition is a complex and costly condition that is common among older adults in the United States (US), with up to half at risk for malnutrition. Malnutrition is associated with several non-medical (i.e., social) factors, including food insecurity. Being at risk for both malnutrition and food insecurity likely identifies a subset of older adults with complex care needs and a high burden of social vulnerability (e.g., difficulty accessing or preparing meals, lack of transportation, and social isolation). US emergency departments (EDs) are a unique and important setting for identifying older patients who may benefit from the provision of health-related social services. This paper describes the protocol development for the Building Resilience and InDependence for Geriatric Patients in the Emergency Department (BRIDGE) study. BRIDGE was designed to assess the feasibility of an ED-based screening process to systematically identify older patients who are at risk for malnutrition and food insecurity and link them to health-related social services to address unmet social needs and support their health and well-being. Methods: Phase 1 efforts will be formative and focused on identifying screening tools, establishing screening and referral workflows, and conducting initial feasibility testing with a cohort of older patients and ED staff. In phase 2, which includes process and outcome evaluation, the screening and referral process will be piloted in the ED. A partnership will be formed with an Area Agency on Aging (AAA) identified in phase 1, to assess resource needs and identify community-based social services for older ED patients who screen positive for both malnutrition risk and food insecurity. Data on screening, referrals, linkage to community-based social services, and patient-reported quality of life and healthcare utilization will be used to assess feasibility. Discussion: The tools and workflows developed and tested in this study, as well as learnings related to forming and maintaining cross-sector partnerships, may serve as a model for future efforts to utilize EDs as a setting for bridging the gap between healthcare and social services for vulnerable patients. [ABSTRACT FROM AUTHOR]

Background: Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder characterized by impairments in social interaction and communication. Oxytocin (OXT), as a neuropeptide, plays a role in emotional and social behaviors. Lactobacillus reuteri (L. reuteri) supplementation led to an OXT-dependent behavioral improvement in ASD mouse models. Despite some promising results from animal studies, little is known about the efficacy of supplementation with L. reuteri, alone or with exogenous OXT therapy, on social-behavioral functions in ASD patients. This paper presents a protocol for a pilot randomized controlled trial to evaluate the feasibility of conducting a full trial comparing oral supplementation of L. reuteri probiotics and intranasal OXT spray to placebo on the effect of social and behavioral functions in ASD patients. The study will also capture preliminary estimates of the efficacy of the proposed interventions in ASD patients. Methods: This pilot trial is a two-staged, randomized, double-blind, placebo-controlled, parallel-group study. Throughout the study (0–24 weeks), 60 patients with ASD will be randomly assigned to receive either oral L. reuteri probiotics or placebo. In the second study stage (13–24 weeks), all participants will receive intranasal OXT spray. As primary outcomes, serum OXT levels will be assayed and social behaviors will be assessed via the Autism Behavior Checklist and the Social Responsiveness Scale which are validated questionnaires, an objective emotional facial matching test, and a new video-based eye-tracking test. Secondary outcomes include the GI-severity-index and Bristol Stool Chart to assess GI function and gut microbiome/short-chain fatty acids. All the outcomes will be assessed at baseline and weeks 12 and 24. Discussion: This pilot study will provide important information on the feasibility of recruitment, blinding and concealment, treatment administration, tolerability and adherence, specimen collection, outcome assessment, potential adverse effects, and the preliminary efficacy on both primary and secondary outcomes. If successful, this pilot study will inform a larger randomized controlled trial fully powered to examine the efficacies of oral L. reuteri probiotics and/or intranasal OXT spray on social-behavioral improvement in ASD patients. Trial registration: ClinicalTrials.gov, NCT03337035. Registered 8 November 2017. [ABSTRACT FROM AUTHOR]