Implementing a text message-based intervention to support type 2 diabetes medication adherence in primary care: a qualitative study with general practice staff.

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.

Exploring non-participation in colorectal cancer screening: A systematic review of qualitative studies.

INTRODUCTION: Worldwide, colorectal cancer is a major public health issue. Despite the existence of screening programmes in many countries, global uptake remains low. This meta-ethnography aimed to analyse qualitative literature to explore attitudes towards colorectal cancer screening and reasons for non-participation in eligible people that do not participate when invited. METHODS: Systematic searches were conducted in five databases in May 2021. Critical appraisal of included studies was performed using the CASP checklist for qualitative studies. FINDINGS: Thirteen studies were included. Three main themes and eight sub-themes were developed across studies: (1) Differences in motivation, with non-participants expressing a lack of knowledge and varying levels of intention to participate but not feeling screening was personally necessary; (2) Active aversion to screening expressed by fear, discomfort, disgust or not wanting to know; and (3) Contextual barriers of the healthcare system such as practical constraints or poor relationships with healthcare professionals. CONCLUSION: Findings suggest multiple pathways to non-participation including ambivalence, aversion to the process and consequences of screening or lack of support. Persuasive messages and prompts to action to target ambivalence, reassurance regarding the screening procedures to target negative reactions, and increased support from healthcare professionals may be beneficial in increasing screening uptake.

Enhancing the implementation of the Making Every Contact Count brief behavioural intervention programme in Ireland: protocol for the Making MECC Work research programme.

Background: Brief behavioural interventions offered by healthcare professionals to target health behavioural risk factors (e.g. physical activity, diet, smoking and drug and alcohol use) can positively impact patient health outcomes. The Irish Health Service Executive (HSE) Making Every Contact Count (MECC) Programme supports healthcare professionals to offer patients brief opportunistic behavioural interventions during routine consultations. The potential for MECC to impact public health depends on its uptake and implementation.   Aim: This protocol outlines the 'Making MECC Work' research programme, a HSE/Health Behaviour Change Research Group collaboration to develop an implementation strategy to optimise uptake of MECC in Ireland. The programme will answer three research questions: (1) What determines delivery of MECC brief interventions by healthcare professionals at individual and organisational levels? (2) What are patient attitudes towards, and experiences of, receiving MECC interventions from healthcare professionals? (3) What evidence-informed implementation strategy options can be consensually developed with key stakeholders to optimise MECC implementation? Methods: In Work Package 1, we will examine determinants of MECC delivery by healthcare professionals using a multi-methods approach, including: (WP1.1) a national survey of healthcare professionals who have participated in MECC eLearning training and (WP1.2) a qualitative interview study with relevant healthcare professionals and HSE staff. In Work Package 2, we will examine patient attitudes towards, and experiences of, MECC using qualitative interviews. Work Package 3 will combine findings from Work Packages 1 and 2 using the Behaviour Change Wheel to identify and develop testable implementation strategy options (WP 3.1). Strategies will be refined and prioritised using a key stakeholder consensus process to develop a collaborative implementation blueprint to optimise and scale-up MECC (WP3.2). Discussion: Research programme outputs are expected to positively support the integration of MECC brief behaviour change interventions into the Irish healthcare system and inform the scale-up of behaviour change interventions internationally.

Community first response and out-of-hospital cardiac arrest: Identifying priorities for data collection, analysis, and use via the nominal group technique.

AIM: Community First Response (CFR) is an important component of Out-of-hospital Cardiac Arrest management in many countries, including Ireland. Reliable, strategic data collection and analysis are required to support the development of CFR. However, data on CFR are currently limited in Ireland and internationally. This research aimed to identify the most important CFR data to record, the most important uses of CFR data, and barriers and facilitators to CFR data collection and use. METHODS: The Nominal Group Technique structured consensus process was used. An expert panel comprising key stakeholders, including volunteers, clinicians, researchers, policy-makers, and a patient, completed a survey to generate lists of the most important CFR data to record and the most important uses of CFR data. Subsequently, they participated in a consensus meeting to agree the top ten priorities from each list. They also identified barriers and facilitators to CFR data collection and use. RESULTS: The top ten CFR data items to record included volunteer response time, interventions/activities completed by volunteers, and the mental/physical impact on volunteers. The top ten most important uses of CFR data included providing feedback to volunteers, improving volunteer training, and measuring CFR effectiveness. Barriers included time constraints and limited training. Facilitators included having appropriate software/equipment and collecting minimal data. CONCLUSION: The results can guide CFR research and inform the development of CFR data collection and analysis policy and practice in Ireland and internationally. Ultimately, improving CFR data collection and use will help to optimise this important intervention and enhance its evidence base.

Identifying the active ingredients of cardiac rehabilitation: A behaviour change technique and qualitative analysis.

OBJECTIVES: Despite evidence that cardiac rehabilitation (CR) can be effective, the active ingredients or behaviour change techniques (BCTs) constituting effective CR remain unclear. There is also a lack of research surrounding patient and facilitator perceptions of active ingredients. This study sought to identify the active ingredients of a community-based CR programme and explore patient and facilitator perceptions of the active ingredients. DESIGN: A multimethod design conducted in two stages, a BCT coding stage and a qualitative stage. METHODS: The BCT coding stage involved the observation and audio recording of ten sessions from a community-based CR programme and the collection of programme materials. Data were coded using the BCT Taxonomy version 1 (Ann Behav Med, 46, 2013, 81). During the qualitative stage, six focus groups were carried out separately with patients (n = 16) and facilitators (n = 4). Qualitative data were analysed using an inductive thematic analysis. RESULTS: The BCT coding phase identified 34 BCTs, many of which were highlighted by patients and facilitators. Patients and facilitators felt the group effort, motivation provided by facilitators, individualized care, knowledge gained, acceptance, and fear reduction enabled change. The majority of BCTs identified in the qualitative stage were also identified in the BCT coding stage, excluding a component related to self-acceptance. Facilitators felt the programme was limited by duration and inadequate psychological support. CONCLUSIONS: The study provides a comprehensive overview of objectively coded BCTs and perceived active ingredients of CR. The findings can be used to inform future refinement and improvement of CR.

Community first response and out-of-hospital cardiac arrest: a qualitative study of the views and experiences of international experts.

OBJECTIVES: This 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. DESIGN: This was a qualitative study in which semistructured interviews were conducted via teleconferencing. The data were analysed in accordance with an established thematic analysis procedure. SETTING: There were participants from 11 countries: UK, USA, Canada, Australia, New Zealand, Singapore, Ireland, Norway, Sweden, Denmark and the Netherlands. PARTICIPANTS: Sixteen 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. RESULTS: The 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. CONCLUSIONS: The 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.

Acceptability of a Mobile Health Behavior Change Intervention for Cancer Survivors With Obesity or Overweight: Nested Mixed Methods Study Within a Randomized Controlled Trial.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13214.

Examining the Impact of an mHealth Behavior Change Intervention With a Brief In-Person Component for Cancer Survivors With Overweight or Obesity: Randomized Controlled Trial.

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.

Identifying behavior change techniques for inclusion in a complex intervention targeting antipsychotic prescribing to nursing home residents with dementia.

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.

Investigating and evaluating evidence of the behavioural determinants of adherence to social distancing measures - A protocol for a scoping review of COVID-19 research.

Background: The WHO has declared the outbreak of coronavirus disease 2019 (COVID-19) as a pandemic. With no vaccine currently available, using behavioural measures to reduce the spread of the virus within the population is an important tool in mitigating the effects of this pandemic. As such, social distancing measures are being implemented globally and have proven an effective tool in slowing the large-scale spread of the virus. Aim: This scoping review will focus on answering key questions about the state of the evidence on the behavioural determinants of adherence to social distancing measures in research on COVID-19.  Methods: A scoping review will be conducted in accordance with guidelines for best practice. Literature searches will be conducted using online databases and grey literature sources. Databases will include Medline, Web of Science, Embase and PsycInfo, alongside relevant pre-print servers. Grey literature will be searched on Google Scholar. Screening, data extraction and quality appraisal will be conducted by members of the research team, with any discrepancies resolved by consensus discussion. Quality appraisal will be conducted using the Cochrane's ROBINS-I tool, the Cochrane Risk of Bias tool, and the JBI Critical Appraisal Checklist where appropriate. Results will be analysed by mapping findings onto the Theoretical Domains Framework and visualising characteristics of the included studies using EviAtlas. This scoping review is pre-registered with Open Science Framework. Conclusions The results of this study may facilitate the systematic development of behavioural interventions to increase adherence to social distancing measures.

Identifying and addressing psychosocial determinants of adherence to physical distancing guidance during the COVID-19 pandemic - project protocol.

Optimising public health physical distancing measures has been a critical part of the global response to the spread of COVID-19. Evidence collected during the current pandemic shows that the transmission rate of the virus is significantly reduced following implementation of intensive physical distancing measures. Adherence to these recommendations has been poorer than adherence to other key transmission reduction behaviours such as handwashing. There are a complex range of reasons that are likely to predict why people do not or only partially adhere to physical distancing recommendations. In the current project we aim to address the following research questions: (1) What are the psychosocial determinants of physical distancing for the general public and for key socio-demographic sub-groups (e.g., young adults, older adults, etc.)?; (2) Do current Government of Ireland COVID-19 physical distancing communications address the determinants of physical distancing?; and (3) How can communications be optimised and tailored to sub-groups to ensure maximum adherence to guidelines? These will be addressed by conducting three work packages (WPs). In WP1, we will work closely with the iCARE international study, which includes a large online survey of public responses to measures established to reduce and slow the spread of COVID-19, including physical distancing. We will analyse Irish data, comparing it to data from other countries, to identify the key psychosocial determinants of physical distancing behaviour. This will be followed by a qualitative study to explore in depth the barriers and facilitators of physical distancing behaviour among the Irish public (WP2). In WP3, we will conduct a content analysis and evidence mapping of current government messaging around physical distancing, to ensure the findings from this research feed into the development of ongoing communication and future messaging about physical distancing.

Comparing Written Versus Pictorial Asthma Action Plans to Improve Asthma Management and Health Outcomes Among Children and Adolescents: Protocol of a Pilot and Feasibility Randomized Controlled Trial.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: Recruitment and data collection began in May 2017 and were completed in October 2018. CONCLUSIONS: 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. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11733.

Childhood obesity prevention: priority areas for future research and barriers and facilitators to knowledge translation, coproduced using the nominal group technique.

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.

Exploring Antipsychotic Prescribing Behaviors for Nursing Home Residents With Dementia: A Qualitative Study.

OBJECTIVES: Caution is advised when prescribing antipsychotics to people with dementia. This study explored the determinants of appropriate, evidence-based antipsychotic prescribing behaviors for nursing home residents with dementia, with a view to informing future quality improvement efforts and behavior change interventions. DESIGN: Semistructured qualitative interviews based on the Theoretical Domains Framework (TDF). SETTING AND PARTICIPANTS: A purposive sample of 27 participants from 4 nursing homes, involved in the care of nursing home residents with dementia (8 nurses, 5 general practitioners, 5 healthcare assistants, 3 family members, 2 pharmacists, 2 consultant geriatricians, and 2 consultant psychiatrists of old age) in a Southern region of Ireland. MEASURES: Using framework analysis, the predominant TDF domains and determinants influencing these behaviors were identified, and explanatory themes developed. RESULTS: Nine predominant TDF domains were identified as influencing appropriate antipsychotic prescribing behaviors. Participants' effort to achieve "a fine balance" between the risks and benefits of antipsychotics was identified as the cross-cutting theme that underpinned many of the behavioral determinants. On one hand, neither healthcare workers nor family members wanted to see residents over-sedated and without a quality of life. Conversely, the reality of needing to protect staff, family members, and residents from potentially dangerous behavioral symptoms, in a resource-poor environment, was emphasized. The implementation of best-practice guidelines was illustrated through 3 explanatory themes ("human suffering"; "the interface between resident and nursing home"; and "power and knowledge: complex stakeholder dynamics"), which conceptualize how different nursing homes strike this "fine balance." CONCLUSIONS: Implementing evidence-based antipsychotic prescribing practices for nursing home residents with dementia remains a significant challenge. Greater policy and institutional support is required to help stakeholders strike that "fine balance" and ultimately make better prescribing decisions. This study has generated a deeper understanding of this complex issue and will inform the development of an evidence-based intervention.

Embedding a user-centred approach in the development of complex behaviour change intervention to improve outcomes for young adults living with type 1 diabetes: The D1 Now Study.

Background: Type 1 diabetes (T1D) is an auto-immune condition which requires intensive self-management. Diabetes self-management is challenging, especially during young adulthood. Effective interventions to improve outcomes for young adults with T1D are needed. This paper describes the development of the D1 Now intervention, employing a user-centred approach to engage with stakeholders in parallel with the application of theory. Methods: Intervention development consisted of 4 phases: 1) the formation of a public and patient involvement (PPI) Young Adult Panel (YAP); 2) a systematic review to synthesise evidence regarding the effectiveness of interventions aimed at improving outcomes for young adults with T1D; 3) understand young adults' diabetes self-management behaviour through engagement with key stakeholders; and 4) an expert consensus meeting to discuss self-management strategies identified in Phase 1 and 3 that would form the core components of the D1 Now intervention. Results: The YAP resulted in meaningful involvement between young adults, researchers and service providers. The systematic review highlighted a lack of quality intervention studies. Qualitative findings highlighted how young adult self-management is driven by complex interactions between external resources, which influence capability, and motivation. The expert panel in Phase 4 highlighted focus areas to improve outcomes for young adults and implementation strategies. Subsequent to these 4 phases, 3 intervention components have been identified: 1) a key worker to liaise with the young adult; 2) an online portal to facilitate relationship building between staff and young adults; and 3) an agenda setting tool to facilitate joint decision-making. Conclusions: This study described the systematic development of an intervention underpinned by theoretical frameworks and PPI, and has identified components for the D1 Now intervention. The resulting intervention content will now be subject to an intervention optimisation process.

Sexual counselling for patients with cardiovascular disease: protocol for a pilot study of the CHARMS sexual counselling intervention.

INTRODUCTION: Sexual 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 ANALYSIS: This 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 DISSEMINATION: This 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.