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Purpose: This paper describes a conceptual framework of maintenance of physical activity and its application to future intervention design. Methods: Evidence from systematic literature reviews and in-depth (N=27) qualitative interviews with individuals with cancer were used to develop a conceptual framework of long-term physical activity behaviour. Determinants of long-term PA were listed and linked with domains of the Theoretical Domains Framework which in turn were linked to associated behaviour change techniques (BCTs) and finally to proposed mechanisms of action (MoA). Results: The conceptual framework is presented within the context of non-modifiable contextual factors (such as demographic and material resources) and in the presence of learnt and adapted behavioural determinants of skills, competence and autonomous motivation that must be established as part of the initiation of physical activity behaviour. An inventory of 8 determinants of engagement in long-term PA after cancer was developed. Clusters of BCTs are presented along with proposed MoA which can be tested using mediation analysis in future trials. Conclusion: Understanding the processes of PA maintenance after cancer and presentation of implementable and testable intervention components and mechanisms of action to promote continued PA can inform future intervention development. Implications for cancer survivors. This resource can act as a starting point for selection of intervention components for those developing future interventions. This will facilitate effective support of individuals affected by cancer to maintain PA for the long term.

Background/Aims Lifestyle, especially diet and alcohol, has been implicated in the causation of gout for centuries and the dietary factors which may trigger flares remain of great interest to people living with gout and their families. However, there is a lack of robust clinical trial evidence about the effectiveness of lifestyle change in people living with gout. The aim of this review was to establish the thoughts, feelings and experiences of people with gout, partners and healthcare professionals about gout, to identify barriers and facilitators to behaviours relating to lifestyle change (diet, alcohol, and physical activity) in people living with gout. Methods A scoping review was undertaken following the stages recommended in Arksey & O’Malley’s scoping studies methodological framework. Databases Embase, MEDLINE, CINAHL, PsycINFO and AMED were searched from January 2000 to October 2021 to identify qualitative studies in gout. Themes were identified within the results of included qualitative studies using thematic synthesis (coding text in the results and then developing themes) and were discussed with both a stakeholder community of practice (COP) group and a patient and public involvement and engagement (PPIE) group. Results 1871 title/abstracts and 158 full papers were screened and 38 qualitative studies in gout were identified. Themes identified in the scoping review are presented in Table 1 and were corroborated with COP and PPIE group members. Examples of potential barriers to lifestyle change in people with gout include poor knowledge, confusing or inadequate information, uncertainty about effectiveness of diet in gout management, stigma, and a reluctance to see healthcare professionals. Potential facilitators for lifestyle change include the desire to prevent flares and pain, the provision of information, and that people with gout already search for information and avoid or consume certain foods. Conclusion This is the first scoping review to identify potential barriers and facilitators to behaviours relating to lifestyle change in people living with gout. Potential barriers include poor knowledge, problems with current information and stigma. The findings will be used to inform the development of the new lifestyle intervention for people living with gout in primary care. Disclosure L. Watson: Grants/research support; Lorraine Watson is funded by the National Institute for Health and Care Research (NIHR) School for Primary Care Research. [Post-doctoral Fellowship Grant reference 2020-347], this (abstract) presents independent research funded by the NIHR. The views expressed are those of the author(s) and not necessarily those of the (partner organisation), the NHS, the NIHR or the Department of Health and Social Care. N. Cornwall: None. C. Jinks: Grants/research support; Clare Jinks is part funded by the National Institute for Health and Care Research (NIHR) Applied Research Collaboration West Midlands. K. Bradbury: Grants/research support; Katherine Bradbury is funded by the National Institute for Health and Care Research (NIHR) Applied Research Collaboration Wessex. L. Goff: None. P. Little: None. C.D. Mallen: Grants/research support; Christian Mallen is funded by the National Institute for Health and Care Research (NIHR) Applied Research Collaboration West Midlands and the NIHR School for Primary Care Research, The School of Medicine as received funding from BMS for a non-pharmacological AF screening trial, Christian Mallen has received grant funding from Wellcome and the Medical Research Council. E. Roddy: None.

Objectives: Severe Acute Respiratory Coronavirus 2 (SARS-CoV-2) was identified in late 2019, spreading to over 200 countries and resulting in almost two million deaths worldwide. The emergence of safe and effective vaccines provides a route out of the pandemic, with vaccination uptake of 75–90% needed to achieve population protection. Vaccine hesitancy is problematic for vaccine rollout; global reports suggest only 73% of the population may agree to being vaccinated. As a result, there is an urgent need to develop equitable and accessible interventions to address vaccine hesitancy at the population level. Study Design & Method: we report the development of a scalable digital intervention seeking to address COVID-19 vaccine hesitancy and enhance uptake of COVID-19 vaccines in the United Kingdom. Guided by motivational interviewing (MI) principles, the intervention includes a series of therapeutic dialogues addressing 10 key concerns of vaccine-hesitant individuals. Development of the intervention occurred linearly across four stages. During stage 1, we identified common reasons for COVID-19 vaccine hesitancy through analysis of existing survey data, a rapid systematic literature review, and public engagement workshops. Stage 2 comprised qualitative interviews with medical, immunological, and public health experts. Rapid content and thematic analysis of the data provided evidence-based responses to common vaccine concerns. Stage 3 involved the development of therapeutic dialogues through workshops with psychological and digital behaviour change experts. Dialogues were developed to address concerns using MI principles, including embracing resistance and supporting self-efficacy. Finally, stage 4 involved digitisation of the dialogues and pilot testing with members of the public. Discussion: the digital intervention provides an evidence-based approach to addressing vaccine hesitancy through MI principles. The dialogues are user-selected, allowing exploration of relevant issues associated with hesitancy in a non-judgmental context. The text-based content and digital format allow for rapid modification to changing information and scalability for wider dissemination.

ObjectivesNasal sprays could be a promising approach to preventing respiratory tract infections (RTIs). This study explored lay people’s perceptions and experiences of using nasal sprays to prevent RTIs to identify barriers and facilitators to their adoption and continued use.DesignQualitative research. Study 1 thematically analysed online consumer reviews of an RTI prevention nasal spray. Study 2 interviewed patients about their reactions to and experiences of a digital intervention that promotes and supports nasal spray use for RTI prevention (reactively: at ‘first signs’ of infection and preventatively: following possible/probable exposure to infection). Interview transcripts were analysed using thematic analysis.SettingPrimary care, UK.Participants407 online customer reviews. 13 purposively recruited primary care patients who had experienced recurrent infections and/or had risk factors for severe infections.ResultsBoth studies identified various factors that might influence nasal spray use including: high motivation to avoid RTIs, particularly during the COVID-19 pandemic; fatalistic views about RTIs; beliefs about alternative prevention methods; the importance of personal recommendation; perceived complexity and familiarity of nasal sprays; personal experiences of spray success or failure; tolerable and off-putting side effects; concerns about medicines; and the nose as unpleasant and unhygienic.ConclusionsPeople who suffer disruptive, frequent or severe RTIs or who are vulnerable to RTIs are interested in using a nasal spray for prevention. They also have doubts and concerns and may encounter problems. Some of these may be reduced or eliminated by providing nasal spray users with information and advice that addresses these concerns or helps people overcome difficulties.

Background A high proportion of hypertensive patients remain above the target threshold for blood pressure, increasing the risk of adverse health outcomes. A digital intervention to facilitate healthcare practitioners (hereafter practitioners) to initiate planned medication escalations when patients’ home readings were raised was found to be effective in lowering blood pressure over 12 months. This mixed-methods process evaluation aimed to develop a detailed understanding of how the intervention was implemented in Primary Care, possible mechanisms of action and contextual factors influencing implementation. Methods One hundred twenty-five practitioners took part in a randomised controlled trial, including GPs, practice nurses, nurse-prescribers, and healthcare assistants. Usage data were collected automatically by the digital intervention and antihypertensive medication changes were recorded from the patients’ medical notes. A sub-sample of 27 practitioners took part in semi-structured qualitative process interviews. The qualitative data were analysed using thematic analysis and the quantitative data using descriptive statistics and correlations to explore factors related to adherence. The two sets of findings were integrated using a triangulation protocol. Results Mean practitioner adherence to escalating medication was moderate (53%), and the qualitative analysis suggested that low trust in home readings and the decision to wait for more evidence influenced implementation for some practitioners. The logic model was partially supported in that self-efficacy was related to adherence to medication escalation, but qualitative findings provided further insight into additional potential mechanisms, including perceived necessity and concerns. Contextual factors influencing implementation included proximity of average readings to the target threshold. Meanwhile, adherence to delivering remote support was mixed, and practitioners described some uncertainty when they received no response from patients. Conclusions This mixed-methods process evaluation provided novel insights into practitioners’ decision-making around escalating medication using a digital algorithm. Implementation strategies were proposed which could benefit digital interventions in addressing clinical inertia, including facilitating tracking of patients’ readings over time to provide stronger evidence for medication escalation, and allowing more flexibility in decision-making whilst discouraging clinical inertia due to borderline readings. Implementation of one-way notification systems could be facilitated by enabling patients to send a brief acknowledgement response. Trial registration (ISRCTN13790648). Registered 14 May 2015.

ObjectivesRespiratory tract infections (RTIs) are extremely common, usually self-limiting, but responsible for considerable work sickness absence, reduced quality of life, inappropriate antibiotic prescribing and healthcare costs. Patients who experience recurrent RTIs and those with certain comorbid conditions have higher personal impact and healthcare costs and may be more likely to suffer disease exacerbations, hospitalisation and death. We explored how these patients experience and perceive their RTIs to understand how best to engage them in prevention behaviours.DesignA qualitative interview study.SettingPrimary care, UK.Methods23 participants who reported recurrent RTIs and/or had relevant comorbid health conditions were interviewed about their experiences of RTIs. Interviews took place as the COVID-19 pandemic began. Data were analysed using inductive thematic analysis.ResultsThree themes were developed: Understanding causes and vulnerability, Attempting to prevent RTIs, Uncertainty and ambivalence about prevention, along with an overarching theme; Changing experiences because of COVID-19. Participants’ understandings of their susceptibility to RTIs were multifactorial and included both transmission via others and personal vulnerabilities. They engaged in various approaches to try to prevent infections or alter their progression yet perceived they had limited personal control. The COVID-19 pandemic had improved their understanding of transmission, heightened their concern and motivation to avoid RTIs and extended their repertoire of protective behaviours.ConclusionsPatients who experience frequent or severe RTIs are likely to welcome and benefit from advice and support regarding RTI prevention. To engage people effectively, those developing interventions or delivering health services must consider their beliefs and concerns about susceptibility and prevention.

Objectives To explore users' reactions to and expectations of the Tinnitus E-Programme 2.0, a digital cognitive behavioural intervention for tinnitus, and to identify contextual factors and mechanisms of action that may influence user engagement with the intervention. Design Qualitative interview study. Methods Think-aloud and semi-structured interviews were carried out with 19 people with tinnitus. Interviews explored participants' views of the intervention's information and advice, its wider intervention goals (e.g. behaviour change, self-management), and factors that may strengthen or impede users' engagement. Data were analysed using inductive thematic analysis, and findings were used to develop a conceptual model of user engagement with the intervention. Results Generally, participants expressed positive views of the intervention, its intervention components, and its design features. Identified contextual factors included pre-existing attitudes, beliefs, skills, and knowledge (e.g. perceptions of tinnitus symptom severity, openness to tinnitus management, and psychological techniques); previous experience of tinnitus management; and characteristics of the condition (e.g. heterogeneous nature of tinnitus, stage in healthcare journey). These contextual factors were hypothesized to influence engagement through four mechanisms of action: motivation to change tinnitus-related attitudes and behaviour; perceived personal relevance of the intervention; expectations of benefit; and appeal of the intervention techniques. Conclusions This study demonstrated the acceptability of the Tinnitus E-Programme 2.0 amongst its target group, while highlighting potential areas for improvement in future intervention modifications. Our findings identified contextual factors that others developing interventions for tinnitus or cognitive behavioural interventions may wish to consider.

BACKGROUND Primary care plays an important role in supporting survivors of cancer; however, support is limited because of practitioners’ perceived lack of expertise and time. A digital intervention for survivors of cancer could provide an efficient way for primary care staff to support survivors of cancer without the need to accumulate expertise and skills to help patients make behavior changes; providing very brief support alongside this could maximize adherence to digital interventions. Renewed is a digital intervention that combines web-based behavior change advice with brief health care practitioner support from a nurse or health care assistant. Knowledge about the views and experiences of primary care staff providing support alongside a digital intervention for survivors of cancer is sparse, limiting the understanding of the acceptability and feasibility of this type of intervention. OBJECTIVE This study aims to explore supporters’ experiences of providing support to survivors of cancer using Renewed, understand potential barriers to and facilitators of the implementation of Renewed in practice, and investigate the strengths and weaknesses of the intervention from the perspective of health care professionals. METHODS This was a qualitative process evaluation nested within a large trial evaluating Renewed. A total of 28 semistructured telephone interviews were conducted with nurses and health care assistants. Data were analyzed using inductive thematic analysis. RESULTS Four themes were developed during the analysis, which reflected the factors that supporters identified as hindering or enabling them to provide support alongside Renewed Online: Renewed Online as an acceptable digital tool with some improvements, confidence in enacting the supporter role, practicalities of delivering support alongside a digital intervention, and managing a patient-led approach. The analysis suggests that supporters perceived that a digital intervention such as Renewed would be beneficial in supporting survivors of cancer in primary care and fit within current practices. However, barriers to providing support alongside the intervention were also identified, including concerns about how to facilitate rapport building and, in a minority, concerns about using a nondirective approach, in which most advice and support is provided through digital interventions, with brief additional support provided by primary care staff. CONCLUSIONS These findings add to the literature on how best to provide support alongside digital interventions, suggesting that although most practitioners cope well with a nondirective approach, a minority requires more training to feel confident in implementing this. This study suggests that the barriers to providing formal support to survivors of cancer in primary care could be successfully overcome with an approach such as Renewed, where a digital intervention provides most of the support and expertise, and health care practitioners provide additional brief human support to maximize engagement. Strategies to maximize the chances of successful implementation for this type of intervention are also discussed.

Background Digital health interventions refer to interventions designed to support health-related knowledge transfer and are delivered via digital technologies, such as mobile apps. Digital health interventions are a double-edged sword: they have the potential to reduce health inequalities, for example, by making treatments available remotely to rural populations underserved by health care facilities or by helping to overcome language barriers via in-app translation services; however, if not designed and deployed with care, digital health interventions also have the potential to increase health inequalities and exacerbate the effects of the digital divide. Objective The aim of this study is to review ways to mitigate the digital divide through digital health intervention design, deployment, and engagement mechanisms sensitive to the needs of digitally excluded populations. Methods This protocol outlines the procedure for a systematic scoping review that follows the methodology recommended by the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidance. The following databases will be searched for primary research studies published in English from October 1, 2011, to October 1, 2021: Cochrane Library, Epistemonikos, NICE Evidence, PROSPERO, PubMed (with MEDLINE and Europe PMC), and Trip. In addition, the following sources of gray literature will be searched: Conference Proceedings Citation Index, Health Management Information Consortium, International HTA Database, OpenGrey, The Grey Literature Report, Google Scholar Basic Search UK, MedNar Deep Web Search Engine, and Carrot2. We will select publications that meet the following inclusion criteria: primary research papers that evaluated digital health interventions that describe features of digital health intervention design and deployment that enable or hinder access to and engagement with digital health interventions by adults from demographic groups likely to be affected by the digital divide (eg, older age, minority ethnic groups, lower income, and lower education level). A random selection of 25 publications identified from the search will be double screened by four reviewers. If there is >75% agreement for included/excluded publications, the team will continue to screen all the identified publications. For all included publications, study characteristics will be extracted by one author and checked for agreement by a second author, with any disagreements resolved by consensus among the study team. Consultation digital health intervention design and deployment, and digital health intervention users will also be conducted in parallel. Results The review is underway and is anticipated to be completed by September 2022. Conclusions The results will have implications for researchers and policy makers using digital health interventions for health improvement peripandemic and post pandemic, and will inform best practices in the design and delivery of digital health interventions. International Registered Report Identifier (IRRID) PRR1-10.2196/32538

BACKGROUND Digital health interventions refer to interventions designed to support health-related knowledge transfer and are delivered via digital technologies, such as mobile apps. Digital health interventions are a double-edged sword: they have the potential to reduce health inequalities, for example, by making treatments available remotely to rural populations underserved by health care facilities or by helping to overcome language barriers via in-app translation services; however, if not designed and deployed with care, digital health interventions also have the potential to increase health inequalities and exacerbate the effects of the digital divide. OBJECTIVE The aim of this study is to review ways to mitigate the digital divide through digital health intervention design, deployment, and engagement mechanisms sensitive to the needs of digitally excluded populations. METHODS This protocol outlines the procedure for a systematic scoping review that follows the methodology recommended by the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidance. The following databases will be searched for primary research studies published in English from October 1, 2011, to October 1, 2021: Cochrane Library, Epistemonikos, NICE Evidence, PROSPERO, PubMed (with MEDLINE and Europe PMC), and Trip. In addition, the following sources of gray literature will be searched: Conference Proceedings Citation Index, Health Management Information Consortium, International HTA Database, OpenGrey, The Grey Literature Report, Google Scholar Basic Search UK, MedNar Deep Web Search Engine, and Carrot2. We will select publications that meet the following inclusion criteria: primary research papers that evaluated digital health interventions that describe features of digital health intervention design and deployment that enable or hinder access to and engagement with digital health interventions by adults from demographic groups likely to be affected by the digital divide (eg, older age, minority ethnic groups, lower income, and lower education level). A random selection of 25 publications identified from the search will be double screened by four reviewers. If there is >75% agreement for included/excluded publications, the team will continue to screen all the identified publications. For all included publications, study characteristics will be extracted by one author and checked for agreement by a second author, with any disagreements resolved by consensus among the study team. Consultation digital health intervention design and deployment, and digital health intervention users will also be conducted in parallel. RESULTS The review is underway and is anticipated to be completed by September 2022. CONCLUSIONS The results will have implications for researchers and policy makers using digital health interventions for health improvement peripandemic and post pandemic, and will inform best practices in the design and delivery of digital health interventions. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/32538

PurposeThe purpose of this study is to comprehensively describe the intervention planning process for the Tinnitus E-Programme 2.0, an Internet-based cognitive behavioral intervention for tinnitus.MethodTheory-, evidence-, and person-based approaches to intervention development were used. In Phase 1, quantitative systematic reviews were used to identify potentially effective intervention techniques and design features. Primary mixed-methods research involving adults with tinnitus explored the acceptability of the first version of the intervention. In Phase 2, person-based guiding principles highlighted key intervention design objectives and features to address needs of the intervention's target group (identified in Phase 1) to maximize its acceptability, feasibility of delivery, and effectiveness. Theory-based “behavioral analysis” and “logic modeling” comprehensively described intervention content and potential mechanisms of action. From this planning work, a prototype intervention was developed.ResultsThe intervention design objectives outlined in the guiding principles were to (a) normalize tinnitus, (b) support users to maintain a regular relaxation practice, (c) minimize the worsening of users' tinnitus sensation, and (d) ensure the intervention is accessible to those with hearing loss. Behavioral analysis and logic modeling identified intervention processes (e.g., illness perceptions, beliefs about consequences, skills, goals) and purported mediators (acceptance of tinnitus, negative thinking, use of the cognitive skills tools for managing negative thoughts, and practicing regular relaxation) hypothesized to facilitate reductions in tinnitus symptom severity.ConclusionsThe guiding principles highlight key design objectives and features to consider when developing interventions for tinnitus. The logic model offers hypothesized mechanisms of action that can be tested in future process analyses.

ObjectivesContextual components of treatment previously associated with patient outcomes include the environment, therapeutic relationship and expectancies. Questions remain about which components are most important, how they influence outcomes and comparative effects across treatment approaches. We aimed to identify significant and strong contextual predictors of patient outcomes, test for psychological mediators and compare effects across three treatment approaches.DesignProspective cohort study with patient-reported and practitioner-reported questionnaire data (online or paper) collected at first consultation, 2 weeks and 3 months.SettingPhysiotherapy, osteopathy and acupuncture clinics throughout the UK.Participants166 practitioners (65 physiotherapists, 46 osteopaths, 55 acupuncturists) were recruited via their professional organisations. Practitioners recruited 960 adult patients seeking treatment for low back pain (LBP).Primary and secondary outcomesThe primary outcome was back-related disability. Secondary outcomes were pain and well-being. Contextual components measured were: therapeutic alliance; patient satisfaction with appointment systems, access, facilities; patients’ treatment beliefs including outcome expectancies; practitioners’ attitudes to LBP and practitioners’ patient-specific outcome expectancies. The hypothesised mediators measured were: patient self-efficacy for pain management; patient perceptions of LBP and psychosocial distress.ResultsAfter controlling for baseline and potential confounders, statistically significant predictors of reduced back-related disability were: all three dimensions of stronger therapeutic alliance (goal, task and bond); higher patient satisfaction with appointment systems; reduced patient-perceived treatment credibility and increased practitioner-rated outcome expectancies. Therapeutic alliance over task (ηp2=0.10, 95% CI 0.07 to 0.14) and practitioner-rated outcome expectancies (ηp2=0.08, 95% CI 0.05 to 0.11) demonstrated the largest effect sizes. Patients’ self-efficacy, LBP perceptions and psychosocial distress partially mediated these relationships. There were no interactions with treatment approach.ConclusionsEnhancing contextual components in musculoskeletal healthcare could improve patient outcomes. Interventions should focus on helping practitioners and patients forge effective therapeutic alliances with strong affective bonds and agreement on treatment goals and how to achieve them.

BackgroundPhysical activity (PA) brief interventions (BIs) involving screening and/or advice are recommended in primary care but frequency of delivery is unknown.AimTo examine the extent to which PA BIs are delivered in primary care, and explore factors associated with delivery, receipt, and patient receptivity.Design and settingA mixed-methods systematic review of studies conducted worldwide, with a narrative synthesis of results.MethodCINAHL, EMBASE, MEDLINE, and APA PsycINFO index databases were searched for qualitative and quantitative studies, dating from January 2012 to June 2020, that reported the level of delivery and/or receipt of PA BIs in primary care, and/or factors affecting delivery, receipt, and patient receptivity. Quality was assessed using the Mixed Methods Appraisal Tool. Attitudes towards and barriers to delivery were coded into the Theoretical Domains Framework and the Capability, Opportunity, and Motivation Behaviour model.ResultsAfter screening a total of 13 066 records, 66 articles were included in the review. The extent of PA screening and advice in primary care varied widely (2.4%–100% and 0.6%–100%, respectively). PA advice was delivered more often to patients with a higher body mass index, lower PA levels, and/or more comorbidities. Barriers — including a lack of time and training/guidelines — remain, despite recommendations from the World Health Organization and National Institute for Health and Care Excellence that PA advice should be provided in primary care. Few studies explored patients’ receptivity to advice.ConclusionPA BIs are not delivered frequently or consistently in primary care. Addressing barriers to delivery through system-level changes and training programmes could improve and increase the advice given. Understanding when patients are receptive to PA interventions could enhance health professionals’ confidence in their delivery.

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.

Background Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults. Objective In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial. Methods In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463). Results Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021. Conclusions The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial. Trial Registration International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980 International Registered Report Identifier (IRRID) DERR1-10.2196/18929

ObjectivesIn the last decade, there has been a rapid expansion of physical activity (PA) promotion programmes and interventions targeting people living with and beyond cancer (LWBC). The impact that these initiatives have on long-term maintenance of PA remains under-researched. This study sought to explore the experiences of participants in order to characterise those who have and have not successfully sustained increases in PA following participation in a PA intervention after a diagnosis of gastrointestinal (GI) cancer, and identify barriers and facilitators of this behaviour.DesignCross-sectional qualitative study. Semi-structured interviews with participants who had previously taken part in a PA programme in the UK, explored current and past PA behaviour and factors that promoted or inhibited regular PA participation. Interviews were audio-recorded, transcribed verbatim and analysed using thematic analysis. Themes and subthemes were identified. Differences between individuals were recognised and a typology of PA engagement was developed.ParticipantsTwenty-seven individuals (n=15 male, mean age=66.3 years) with a diagnosis of GI cancer who had participated in one of four interventions designed to encourage PA participation.SettingUK.ResultsSeven themes were identified: disease processes, the role of ageing, emotion and psychological well-being, incorporating PA into everyday life, social interaction, support and self-monitoring and competing demands. A typology with three types describing long-term PA engagement was generated: (1) maintained PA, (2) intermittent PA, (3) low activity. Findings indicate that identifying an enjoyable activity that is appropriate to an individual’s level of physical functioning and is highly valued is key to supporting long-term PA engagement.ConclusionThe typology described here can be used to guide stratified and personalised intervention development and support sustained PA engagement by people LWBC.

Physical activity (PA) is central to maintaining health and wellbeing as we age. Valid, reliable measurement tools are vital for understanding, and evaluating PA. There are limited options for comprehensively, accurately and affordably measuring older adults&rsquo, PA at scale at present. We aimed to develop a digital PA measurement tool specifically for adults aged 65+ using a person-based approach. We collated evidence from target users, field experts and the relevant literature to learn how older adults comprehend PA and would accept a digital tool. Findings suggest that older adults&rsquo, PA is often integrated into their daily life activities and that commonly applied terminology (e.g., moderate and vigorous) can be difficult to interpret. We also found that there is increasing familiarity with digital platforms amongst older adults, and that technological simplicity is valued. These findings informed the development of a digital tool that asks users to report their activities across key PA domains and dimensions from the previous 7-days. Users found the tool easy to navigate and comprehensive in terms of activity reporting. However, real-world usability testing revealed that users struggled with seven-day recall. Further work will address the identified issues, including creating a single-day reporting option, before commencing work to validate this new tool.

Purpose: This study explored participant views of a web-based physical activity intervention for older adults and examined how they resonate with the key principles that guided intervention development. Methods: Qualitative interviews were carried out with 52 older adults. A deductive qualitative analysis approach was taken, based around the intervention’s key principles. Results: Participants expressed mostly positive views of the intervention features, broadly confirming the appropriateness of the key principles, which were to: (a) encourage intrinsic motivation for physical activity, (b) minimize the risk of users receiving activity suggestions that are inappropriate or unsafe, (c) offer users choice regarding the activities they engage with and build confidence to undertake more activity, and (d) minimize the cognitive load and need to engage with the intervention website. The findings also identified ways in which content could be improved to further increase acceptability. Conclusion: This study illustrates how using the person-based approach has enabled the identification and implementation of features that older adults appreciate.

Background By 2050 worldwide dementia prevalence is expected to triple, rising to 152 million. Affordable, scalable interventions are required to support protective behaviours such as physical activity, cognitive training and healthy eating. This paper outlines the development of ‘Active Brains’: a multi-domain digital behaviour change intervention to reduce cognitive decline amongst older adults, and key findings arising from this process. Methods A theory-, evidence- and person-based approach to intervention development was undertaken. Scoping reviews and behavioural analysis contributed to intervention planning. Optimisation involved qualitative interviews with 52 older adults with higher and lower cognitive performance scores. Data were analysed thematically and informed changes. Results The development process synthesised findings from planning and optimisation activities. Scoping reviews and qualitative interviews suggested that the same intervention content should 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 highly acceptable intervention content and functionality for 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, the insights obtained through our development process may be useful for others working with, and developing interventions for, older adults and/or those with cognitive impairment.

BACKGROUND Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults. OBJECTIVE In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial. METHODS In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463). RESULTS Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021. CONCLUSIONS The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial. CLINICALTRIAL International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/18929

BackgroundBy 2050 worldwide dementia prevalence is expected to triple, rising to 152 million. Affordable, scalable interventions are required to support protective behaviours such as physical activity, cognitive training and healthy eating. This paper outlines the development of ‘Active Brains’: a multi-domain digital behaviour change intervention to reduce cognitive decline amongst older adults, and key findings arising from this process.MethodsA theory-, evidence- and person-based approach to intervention development was undertaken. Scoping reviews and behavioural analysis contributed to intervention planning. Optimisation involved qualitative interviews with 52 older adults with higher and lower cognitive performance scores. Data were analysed thematically and informed changes.ResultsThe development process synthesised findings from planning and optimisation activities. Scoping reviews and qualitative interviews suggested that the same intervention content should 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 highly acceptable intervention content and functionality for target users.ConclusionsA 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, the insights obtained through our development process may be useful for others working with, and developing interventions for, older adults and/or those with cognitive impairment.

IntroductionLong COVID-19 is a distressing, disabling and heterogeneous syndrome often causing severe functional impairment. Predominant symptoms include fatigue, cognitive impairment (‘brain fog’), breathlessness and anxiety or depression. These symptoms are amenable to rehabilitation delivered by skilled healthcare professionals, but COVID-19 has put severe strain on healthcare systems. This study aims to explore whether digitally enabled, remotely supported rehabilitation for people with long COVID-19 can enable healthcare systems to provide high quality care to large numbers of patients within the available resources. Specific objectives are to (1) develop and refine a digital health intervention (DHI) that supports patient assessment, monitoring and remote rehabilitation; (2) develop implementation models that support sustainable deployment at scale; (3) evaluate the impact of the DHI on recovery trajectories and (4) identify and mitigate health inequalities due to the digital divide.Methods and analysisMixed-methods, theoretically informed, single-arm prospective study, combining methods drawn from engineering/computer science with those from biomedicine. There are four work packages (WP), one for each objective. WP1 focuses on identifying user requirements and iteratively developing the intervention to meet them; WP2 combines qualitative data from users with learning from implementation science and normalisation process theory, to promote adoption, scale-up, spread and sustainability of the intervention; WP3 uses quantitative demographic, clinical and resource use data collected by the DHI to determine illness trajectories and how these are affected by use of the DHI; while WP4 focuses on identifying and mitigating health inequalities and overarches the other three WPs.Ethics and disseminationEthical approval obtained from East Midlands – Derby Research Ethics Committee (reference 288199). Our dissemination strategy targets three audiences: (1) Policy makers, Health service managers and clinicians responsible for delivering long COVID-19 services; (2) patients and the public; (3) academics.Trial registration numberResearch Registry number: researchregistry6173.

BackgroundAn online weight management intervention (POWeR+) combined with a small amount of primary care healthcare practitioner support is effective in helping patients to lose weight, but little is known about how practitioners interact with the POWeR+ intervention or their experiences of providing support for patients using POWeR+. The aim of this study was to explore practitioners’ usage of POWeR+ and their experiences of providing support to patients using POWeR+. MethodsSet within a randomised controlled trial of POWeR+, practitioners’ usage of POWeR+ was automatically captured and a qualitative process analysis was conducted employing semi-structured telephone interviews with practitioners who provided support to patients using POWeR+. The usage analysis captured how 54 practitioners used the POWeR+ intervention. Thirteen telephone interviews explored practitioners’ experiences of using POWeR+ and providing patients with face-to-face or remote (email and telephone) support. Interview data were analysed using inductive thematic analysis. ResultsUsage analysis indicated that almost all practitioners engaged with POWeR+. Pages which displayed patients’ progress and allowed practitioners to email patients were used the most. Practitioners found POWeR+ straightforward and easy to use. Some practitioners preferred providing support face-to-face, which they enjoyed more than remote support. A small number of nurses found providing non-directive support using the CARe approach (Congratulate, Ask, Remind) challenging, feeling it was the opposite of their normal approach. POWeR+ enabled practitioners to raise the topic of weight loss with patients, and POWeR+ was viewed as a superior alternative to existing weight management support which was limited in most practices. Still some practitioners found it difficult to fit providing support into their busy schedules. ConclusionsOverall, practitioners engaged well with POWeR+ and perceived providing patients with support whilst using POWeR+ as acceptable and feasible. CARe provides a potentially useful model for how practitioners can combine human and digital support in a cost-effective way, which could be useful for the management of other conditions. Some potential barriers to implementation were identified, which allowed modification of POWeR+. The findings suggest that implementing this cost-effective online weight management intervention in Primary Care would be feasible and acceptable to practitioners.

This paper illustrates a rigorous approach to developing digital interventions using an evidence-, theory- and person-based approach. Intervention planning included a rapid scoping review that identified cancer survivors’ needs, including barriers and facilitators to intervention success. Review evidence (N = 49 papers) informed the intervention’s Guiding Principles, theory-based behavioural analysis and logic model. The intervention was optimised based on feedback on a prototype intervention through interviews (N = 96) with cancer survivors and focus groups with NHS staff and cancer charity workers (N = 31). Interviews with cancer survivors highlighted barriers to engagement, such as concerns about physical activity worsening fatigue. Focus groups highlighted concerns about support appointment length and how to support distressed participants. Feedback informed intervention modifications, to maximise acceptability, feasibility and likelihood of behaviour change. Our systematic method for understanding user views enabled us to anticipate and address important barriers to engagement. This methodology may be useful to others developing digital interventions.

Due to increasing digitalisation, today&rsquo, s working world is changing rapidly and provides managers with new challenges. Digital leadership is an important factor in managing these challenges and has become a key concept in the discussion about what kinds of skills managers need for digital transformation. The main research question our study explored was if digital leadership is associated with psychological well-being in upper-level managers. Based on a qualitative pilot study and relevant literature, we developed a new scale for digital leadership in managers. We conducted an online survey with a sample of 368 upper-level managers from a large German ICT-company. Using a stepwise logistic regression analysis, potential effects of digital leadership on psychological well-being (WHO-5) were analysed. Logistic regression analyses showed that better skills in digital leadership were significantly associated with higher well-being. Results also showed that gender, age and managerial experience had no effect in our model. Our study provides a valuable insight into the association between digital leadership and well-being in managers. However, further research is necessary to validate the newly developed scale for digital leadership and to confirm a causal effect in the relationship between digital leadership and well-being.