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This worked example demonstrates how evidence and stakeholder views can be combined to select active behavior change ingredients, known as behavior change techniques (BCTs), when developing interventions. Abstract Nursing home residents with dementia are commonly prescribed antipsychotics despite the associated increased risk of harms. Interventions to optimize prescribing practice have been found to be effective in the short term, but there is a lack of evidence to support sustainability of effects, along with a lack of theory, public involvement, and transparency in the intervention development process. Using theory has been advocated as a means of improving intervention sustainability. The aim of this study was, therefore, to identify behavior change techniques (BCTs) for inclusion in a complex intervention targeting antipsychotic prescribing to nursing home residents with dementia. A comprehensive approach to identifying a long list of all potential BCTs from three different sources was undertaken. The most appropriate BCTs were then selected through a two-round Delphi consensus survey with a broad range of experts (n = 18 panelists). Advisory groups of people with dementia, family carers, and professional stakeholders provided feedback on the final BCTs included. After two Delphi survey rounds, agreement was reached on 22 BCTs. Further refinement of the selected BCTs based on advisory group and panelists’ feedback, along with use of the APEASE criteria (Affordability, Practicability, Effectiveness, Acceptability, Side effects/safety, and Equity) resulted in a final list of 16 BCTs. The next step in intervention development will be to identify the most appropriate mode of delivery of the 16 BCTs identified for inclusion. The study provides a case example of a systematic approach to incorporating evidence with stakeholder views in the identification of appropriate BCTs.

Background: Cancer survivorship in Ireland is increasing in both frequency and longevity. However, a significant proportion of cancer survivors do not reach the recommended physical activity levels and have overweight. This has implications for both physical and psychological health, including an increased risk of subsequent and secondary cancers. Mobile health (mHealth) interventions demonstrate potential for positive health behavior change, but there is little evidence for the efficacy of mobile technology in improving health outcomes in cancer survivors with overweight or obesity. Objective: This study aims to investigate whether a personalized mHealth behavior change intervention improves physical and psychological health outcomes in cancer survivors with overweight or obesity. Methods: A sample of 123 cancer survivors (BMI≥25 kg/m2) was randomly assigned to the standard care control (n=61) or intervention (n=62) condition. Group allocation was unblinded. The intervention group attended a 4-hour tailored lifestyle education and information session with physiotherapists, a dietician, and a clinical psychologist to support self-management of health behavior. Over the following 12 weeks, participants engaged in personalized goal setting to incrementally increase physical activity (with feedback and review of goals through SMS text messaging contact with the research team). Direct measures of physical activity were collected using a Fitbit accelerometer. Data on anthropometric, functional exercise capacity, dietary behavior, and psychological measures were collected at face-to-face assessments in a single hospital site at baseline (T0), 12 weeks (T1; intervention end), and 24 weeks (T2; follow-up). Results: The rate of attrition was 21% (13/61) for the control condition and 14% (9/62) for the intervention condition. Using intent-to-treat analysis, significant reductions in BMI (F2,242=4.149; P=.02; ηp2=0.033) and waist circumference (F2,242=3.342; P=.04; ηp2=0.027) were observed in the intervention group. Over the 24-week study, BMI was reduced by 0.52 in the intervention condition, relative to a nonsignificant reduction of 0.11 in the control arm. Waist circumference was reduced by 3.02 cm in the intervention condition relative to 1.82 cm in the control condition. Physical activity level was significantly higher in the intervention group on 8 of the 12 weeks of the intervention phase and on 5 of the 12 weeks of the follow-up period, accounting for up to 2500 additional steps per day (mean 2032, SD 270). Conclusions: The results demonstrate that for cancer survivors with a BMI≥25 kg/m2, lifestyle education and personalized goal setting using mobile technology can yield significant changes in clinically relevant health indicators. Further research is needed to elucidate the mechanisms of behavior change and explore the capacity for mHealth interventions to improve broader health and well-being outcomes in the growing population of cancer survivors. Trial Registration: ISRCTN Registry ISRCTN18676721; https://www.isrctn.com/ISRCTN18676721 International Registered Report Identifier (IRRID): RR2-10.2196/13214

IntroductionSexual problems are common with cardiovascular disease, and can negatively impact quality of life. To address sexual problems, guidelines have identified the importance of sexual counselling during cardiac rehabilitation, yet this is rarely provided. The Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention aims to improve the provision of sexual counselling in cardiac rehabilitation in Ireland.Methods and analysisThis is a multicentre pilot study for the CHARMS intervention, a complex, multilevel intervention delivered within hospital-based cardiac rehabilitation programmes. The intervention includes (1) training in sexual counselling for staff, (2) a staff-led patient education and support intervention embedded within the cardiac rehabilitation programme, (3) a patient information booklet and (4) an awareness raising poster. The intervention will be delivered in two randomly selected cardiac rehabilitation centres. In each centre 30 patients will be recruited, and partners will also be invited to participate. Data will be collected from staff and patients/partners at T1 (study entry), T2 (3-month follow-up) and T3 (6-month follow-up). The primary outcome for patients/partners will be scores on the Sexual Self-Perception and Adjustment Questionnaire. Secondary outcomes for patients/partners will include relationship satisfaction; satisfaction with and barriers to sexual counselling in services; sexual activity, functioning and knowledge; physical and psychological well-being. Secondary outcomes for staff will include sexuality-related practice; barriers to sexual counselling; self-ratings of capability, opportunity and motivation; sexual attitudes and beliefs; knowledge of cardiovascular disease and sex. Fidelity of intervention delivery will be assessed using trainer self-reports, researcher-coded audio recordings and exit interviews. Longitudinal feasibility data will be gathered from patients/partners and staff via questionnaires and interviews.Ethics and disseminationThis study is approved by the Research Ethics Committee (REC) of the National University of Ireland, Galway. Findings will be disseminated to cardiac rehabilitation staff, patients/partners and relevant policymakers via appropriate publications and presentations.

Asthma is an important focus for pediatric health research as management of asthma symptoms is a significant challenge, and morbidity and mortality among youths with asthma remain prevalent. Treatment guidelines for asthma recommend a written asthma action plan (WAAP) that summarizes individualized instructions for daily medication use. However, WAAPs are typically written at a seventh- to ninth-grade reading level, which can be a barrier to young people in understanding their treatment, having confidence in using a WAAP, and engaging with asthma education. Utilizing a feasibility and pilot randomized controlled trial (RCT) design, the objective of the Take Action for Asthma Control study is to test a symptom-based, computer-generated pictorial asthma action plan (PAAP) in comparison with a standard WAAP and assess the feasibility and acceptability of the asthma action plan (AAP) intervention and study procedures. The study has 3 aims: (1) estimate the effect sizes of PAAPs compared with WAAPs on outcomes (eg, AAP knowledge and medication adherence), (2) evaluate feasibility and acceptability of AAP intervention and RCT procedures from the perspectives of key stakeholders, and (3) establish whether parent and youth literacy levels are associated with treatment outcomes. This feasibility and pilot RCT is a block randomized, 2-arm, parallel-group clinical trial, lasting 6 months in duration. At baseline, participants will be randomly assigned to receive a PAAP or WAAP generated for them and reviewed with them by their asthma physician. Study procedures will take place over 4 separate time points: a baseline clinic appointment, 1-month telephone follow-up, and 3- and 6-month clinic-based follow-ups. At each time point, data will be collected related to the main outcomes: AAP knowledge, AAP satisfaction, asthma control, pulmonary function, and adherence to daily asthma medication. A sample size of up to 60 participants (aged 8-17 years) will be recruited. Feasibility and acceptability data will be collected via one-to-one qualitative interviews with providers involved in the study and a subgroup of families that participate in the study. Recruitment and data collection began in May 2017 and were completed in October 2018. This pilot and feasibility study will test the potential efficacy, feasibility, and acceptability of an AAP intervention and study procedures. The findings will inform the design and delivery of a future definitive trial to assess the efficacy of PAAPs versus WAAPs in supporting asthma self-management among children and adolescents. DERR1-10.2196/11733.

Background The Support through Mobile Messaging and digital health Technology for Diabetes (SuMMiT-D) project has developed, and is evaluating, a mobile phone-based intervention delivering brief messages targeting identified behaviour change techniques promoting medication use to people with type 2 diabetes in general practice. The present study aimed to inform refinement and future implementation of the SuMMiT-D intervention by investigating general practice staff perceptions of how a text message-based intervention to support medication adherence should be implemented within current and future diabetes care. Methods Seven focus groups and five interviews were conducted with 46 general practice staff (including GPs, nurses, healthcare assistants, receptionists and linked pharmacists) with a potential role in the implementation of a text message-based intervention for people with type 2 diabetes. Interviews and focus groups were audio-recorded, transcribed and analysed using an inductive thematic analysis approach. Results Five themes were developed. One theme ‘The potential of technology as a patient ally’ described a need for diabetes support and the potential of technology to support medication use. Two themes outlined challenges to implementation, ‘Limited resources and assigning responsibility’ and ‘Treating the patient; more than diabetes medication adherence’. The final two themes described recommendations to support implementation, ‘Selling the intervention: what do general practice staff need to see?’ and ‘Fitting the mould; complementing current service delivery’. Conclusions Staff see the potential for a text message-based support intervention to address unmet needs and to enhance care for people with diabetes. Digital interventions, such as SuMMiT-D, need to be compatible with existing systems, demonstrate measurable benefits, be incentivised and be quick and easy for staff to engage with. Interventions also need to be perceived to address general practice priorities, such as taking a holistic approach to care and having multi-cultural reach and relevance. Findings from this study are being combined with parallel work with people with type 2 diabetes to ensure stakeholder views inform further refinement and implementation of the SuMMiT-D intervention.

ObjectivesThis research aimed to examine the perspectives, experiences and practices of international experts in community first response: an intervention that entails the mobilisation of volunteers by the emergency medical services to respond to prehospital medical emergencies, particularly cardiac arrests, in their locality.DesignThis was a qualitative study in which semistructured interviews were conducted via teleconferencing. The data were analysed in accordance with an established thematic analysis procedure.SettingThere were participants from 11 countries: UK, USA, Canada, Australia, New Zealand, Singapore, Ireland, Norway, Sweden, Denmark and the Netherlands.ParticipantsSixteen individuals who held academic, clinical or managerial roles in the field of community first response were recruited. Maximum variation sampling targeted individuals who varied in terms of gender, occupation and country of employment. There were eight men and eight women. They included ambulance service chief executives, community first response programme managers and cardiac arrest registry managers.ResultsThe findings provided insights on motivating and supporting community first response volunteers, as well as the impact of this intervention. First, volunteers can be motivated by ‘bottom-up factors’, particularly their characteristics or past experiences, as well as ‘top-down factors’, including culture and legislation. Second, providing ongoing support, especially feedback and psychological services, is considered important for maintaining volunteer well-being and engagement. Third, community first response can have a beneficial impact that extends not only to patients but also to their family, their community and to the volunteers themselves.ConclusionsThe findings can inform the future development of community first response programmes, especially in terms of volunteer recruitment, training and support. The results also have implications for future research by highlighting that this intervention has important outcomes, beyond response times and patient survival, which should be measured, including the benefits for families, communities and volunteers.

Childhood obesity is a significant public health challenge, yet research priorities for childhood obesity prevention are not established. Coproduction of priorities leads to research which may be more translatable to the domains of policy and practice. The aim of the present study was to identify knowledge gaps and research priorities in addition to facilitators and barriers to knowledge translation in childhood obesity prevention. The nominal group technique involving consensus building with researchers, policymakers, and practitioners was employed during workshops at a national obesity conference held over 2 days in May 2017. Seventy-seven people participated in the first round of research prioritization on Day 1, while 14 stakeholders participated on Day 2. The top five research priorities identified were as follows: (i) Evaluate (including economic evaluation) current programs to inform practice and policy; (ii) How to change culture toward addressing the determinants of health; (iii) Implementation science: process; (iv) How to integrate obesity prevention into existing service structures; (v) How to enhance opportunities for habitual physical activity, including free play and active travel. Key themes emerging from this research prioritization exercise were the importance of funding and resources, coproduction of research, and a focus on both implementation research and social determinants within the field of childhood obesity prevention. The coproduced research priorities may help to shape the research agendas of funders and researchers, and aid in the conduct of policy-relevant research and the translation of research into practice in childhood obesity prevention.

Introduction: Developing and promoting healthcare services that engage and empower people requires research to focus on areas of relevance to key stakeholders. To engage with key stakeholders, we conducted a research prioritisation process with people with diabetes, health professionals and policy makers to identify the most important topics to research in diabetes in Ireland. Key stakeholders identified low attendance at structured education for Type 2 diabetes (T2DM) as a priority area for research in Ireland. Despite evidence that structured education programmes can support self-care and improve clinical, lifestyle and psychosocial outcomes in T2DM, attendance rates in Ireland are low.The aim of this study was to address this proprity by exploring barriers and facilitators to attendance at T2DM structured education programmes in Ireland.Methods: People with T2DM who had attended, or been invited to attend, at one of the three structured education programmes (CODE, DESMOND and X-PERT) available in Ireland and educators from each of the programmes took part in semi-structured telephone interviews. Interviews were audio-taped, transcribed and analysed using inductive thematic analysis.Results: 15 people with T2DM and 14 educators were interviewed. People with T2DM who attended programmes were overwhelmingly positive about their experience. Reasons for non-attendance included not knowing programmes were available, not appreciating the potential benefits, and not wanting to admit to the reality of diabetes. Analysis also identified innovations to increase attendance developed by educators in different areas, and the role of healthcare professionals in promoting structured education.Conclusions: People with T2DM see clear benefits of structured education after attending but need information and encouragement from their healthcare team to support attendance. Healthcare professionals have a key role in promoting structured education and empowering people to self-care. The innovative strategies developed by educators across the country to promote structured education could be better communicated and standardised nationally.Lessons learned: It is possible to engage a diverse group of stakeholders to identify targets for research. Engaging key stakeholders facilitated recruitment to this study as the topic developed from a need identified by stakeholders. We hope that engaging with people with diabetes, healthcare professionals and policy makers from the beginning of our programme of research will maximise the potential for the future translation of findings into practice.Limitations: Our interviews were conducted with people with diabetes who had attended at structured education programmes. Exploring reasons for non-attendance with people who had not attended is also important, but was not included in the current study.Suggestions for future research: The findings from this study will inform the development of an intervention to increase attendance at structured education programmes in Ireland.

Background Many people living with cardiovascular disease (CVD) are affected by sexual problems associated with the condition. International guidelines recommend all patients with CVD should receive sexual counselling, yet this is rarely provided by health professionals. The current study piloted the Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention, a complex multi-level intervention designed to increase the implementation of sexual counselling guidelines in hospital-based cardiac rehabilitation (CR) in Ireland. Methods The CHARMS intervention, consisting of awareness training and skills development for staff, and education and support for patients, was implemented in two CR centres. Following a repeated measures design, quantitative and qualitative feasibility, fidelity, cost, and outcome data were collected from staff and patients at baseline (T1, pre-intervention), at 3 months post-baseline (T2, post-intervention), and at 6 months post-baseline (T3, post-intervention). Data were organised according to a 14-point reporting framework of methodological issues that should be examined in pilot and feasibility studies. To inform a future definitive trial, potential solutions to identified feasibility issues were generated using the ADePT process for decision-making after pilot and feasibility trials. Results Most elements of the study protocol were executed smoothly, and intervention implementation was successful. Patients’ ( N  = 42) responses to the intervention were positive. The reporting framework and the ADePT process facilitated the identification of two overarching feasibility problems, as well as solutions to be implemented in a definitive trial: (1) a high level of patient attrition in the pilot study, to be addressed through the use of financial incentives, reducing the length of the patient questionnaire, and providing a telephone survey option; and (2) negative staff perceptions, to be addressed through an augmented staff intervention, reframing ‘sexual counselling’ as ‘sexual education and support’ to fit with professional role perceptions, and reviewing all intervention terminology with a CR staff member to ensure acceptability. Conclusions This article reports the successful piloting of a novel sexual counselling implementation intervention in cardiac rehabilitation. The utilisation of an extended reporting framework and the ADePT process facilitated the identification of adaptations necessary to ensure the feasibility of a definitive trial, thereby maximising methodological transparency.

A significant proportion of cancer survivors have overweight or obesity. Although this has negative implications for health, weight management is not a standard component of oncology aftercare. Mobile health (mHealth) technology, in combination with behavior change techniques (BCTs), has the potential to support positive lifestyle changes. Few studies have been carried out with cancer survivors; therefore, the acceptability of these tools and techniques requires further investigation. The aim of this study is to examine the acceptability of a behavior change intervention using mHealth for cancer survivors with a BMI of 25 or more and to gather constructive feedback from participants. The intervention consisted of educational sessions and an 8-week physical activity goal setting intervention delivered using mobile technology (ie, Fitbit activity monitor plus SMS contact). In the context of a two-arm randomized controlled trial, semistructured interviews were conducted to assess the retrospective acceptability of the intervention from the perspective of the recipients. The theoretical framework for the acceptability of health care interventions was used to inform a topic guide. The interviews were transcribed and analyzed using thematic analysis. A quantitative survey was also conducted to determine the acceptability of the intervention. A total of 13 participants were interviewed, and 36 participants completed the quantitative survey. The results strongly support the acceptability of the intervention. The majority of the survey respondents held a positive attitude toward the intervention (35/36, 97%). In qualitative reports, many of the intervention components were enjoyed and the mHealth components (ie, Fitbit and goal setting through text message contact) were rated especially positively. Responses were mixed as to whether the burden of participating in the intervention was high (6/36, 17%) or low (5/36, 14%). Participants perceived the intervention as having high efficacy in improving health and well-being (34/36, 94%). Most respondents said that they understood how the intervention works (35/36, 97%), and qualitative data show that participants' understanding of the aim of the intervention was broader than weight management and focused more on moving on psychologically from cancer. On the basis of the coherence of responses with theorized aspects of intervention acceptability, we are confident that this intervention using mHealth and BCTs is acceptable to cancer survivors with obesity or overweight. Participants made several recommendations concerning the additional provision of social support. Future studies are needed to assess the feasibility of delivery in clinical practice and the acceptability of the intervention to those delivering the intervention. RR2-10.2196/13214.