Title: Understanding and Improving Medication Adherence in people living with Inflammatory Bowel Disease (IBD): Co-designing and Feasibility Testing of a Behavioural Intervention to promote adherence to IBD medications
Funder: Department of Health and Social Care

Abstract: Research question: How can medication adherence be improved in people living with Inflammatory Bowel Disease(IBD)? Background: IBD affects 600,000 people in the UK, being associated with unpredictable gut inflammation[10,11]. There is no cure. Inflammation is managed with medication, however 53-75% of people with IBD do not take this as prescribed[12,13]. Understanding barriers to adherence will allow development of an individualised adherence-support intervention that may improve disease-related outcomes[10,14,15]. Aims: Explore if and how adherence can be improved in IBD. Objectives: 1)Identify, understand and measure intentional and unintentional non-adherence in IBD.2)Collaboratively develop a website adherence intervention with people with IBD and healthcare professionals(HCPs). 3)Test intervention feasibility. Methods: Theoretical underpinning of this mixed-methods study will be informed by: -systematic and scoping reviews (completed early 2022), -overarching behaviour-change framework of COM-B[16], -Perceptions and Practicalities Approach[17] and Common-Sense Model[18,19] facilitating understanding of adherence in IBD. -Intervention Development underpinned by: recent Medical Research Council Framework on developing and evaluating complex interventions[20], NICE Guidelines[21] and multifaceted behaviour-change techniques. Phase1a) Qualitative interviews(months1-10); participants (n=20) recruited from an NHS gastroenterology outpatient clinic and IBD charity websites, and HCPs(n=20) recruited nationally, will explore intentional and non-intentional non-adherence to IBD medication. Data will be analysed thematically[22,23]. Phase1b) Cross-sectional survey(months5-14); investigating adherence to IBD medication. Participants (n=100) recruited from an NHS gastroenterology outpatient clinic and charity websites, will complete a survey including tools quantifying intentional and unintentional non-adherence. Results will be analysed with descriptive statistics and associations. Phase 1a+1b data will identify facilitators, barriers and necessary behaviours for IBD adherence. Findings will be mapped to COM-B[16]; enabling creation of a theoretical-framework for intervention development and adherence behaviour-change. Phase2) Intervention development(months15-22); in collaboration with Advisory groups, all participants recruited from Phase 1a(n=40) who expressed interest in intervention-development will be invited to partake. Participants (n=10/workshop; 4PLwIBD, 4HCPs) will complete an anonymous pre-workshop survey and attend two half-day intervention-development workshops, informed by Phase1 outcomes, current adherence interventions(from previous scoping review), NICE and MRC guidelines and multifaceted behaviour-change techniques.Descriptive statistics will analyse anonymous pre-workshop survey data indicating preliminary priorities to intervention methods. Thematic analysis of workshop content mapped to COM-B[16], will be iteratively applied developing an intervention prototype, aiming to tailor to individual need whilst addressing adherence-related concerns, in collaboration with Advisory groups and Supervisors. Phase3) Feasibility testing (months23-30); participants(n=15) from Phase1b with current poor adherence to IBD medications(based upon Phase 1b outcomes), will test the intervention for 8weeks. Data collection/analysis enabling intervention refinement will include: -Quantitative data collection(baseline(0), 8-weeks):measuring adherence and intervention usage. -Semi-structured qualitative interviews(8-weeks):thematically exploring intervention usability, acceptability and recommendations for enhancement. Results will inform intervention refinement, ready for further testing in post-doctoral research. Anticipated Impact and Dissemination: This research will be a PhD incorporating four high-impact publications and national and international conferences: -Phases1a+1b)Deeper understanding of medication adherence in IBD, through i)lived experiences and ii)quantifiable outcomes. -Phase2)A tailored theoretically-informed website adherence-support intervention for people with IBD. -Phase3)Feasibility testing of an adherence-support intervention based on user-testing. Collaboration with PPI members will promote dissemination via public engagements, charities, educational events and social media.

Lay abstract: Aims: This research aims to understand the challenges experienced by people living with Inflammatory Bowel Disease (PLwIBD) in taking their Inflammatory Bowel Disease (IBD) medicine. This information will guide the design of an intervention for PLwIBD which will: -encourage personalised treatment and medication monitoring, -offer ongoing support that is convenient and accessible, -facilitate PLwIBD to take medications as prescribed. The intervention will then be tested by PLwIBD to see if it is usable and acceptable. Background: IBD is a lifelong condition of inflammation of the gut. IBD cannot be cured, but can usually be controlled through medication, which is most effective when taken as prescribed, known as adherence. For multiple reasons PLwIBD sometimes find it difficult to adhere to medications. As many as 72% do not take medications as advised. If barriers to adherence are identified and understood, a support-programme to target these barriers can be designed to improve adherence. The potential impact of such an intervention could be increased patient well-being and improved quality of life, through better controlled IBD. Design and Methods: Prior the fellowship, thorough reviews of all available research will identify: i)causes of why PLwIBD may not take their IBD medication, and ii)research which has successfully supported people with long-term health conditions to take their medication. Phase1a: Interviews with approximately 20 PLwIBD and 20 healthcare professionals will aim to understand why PLwIBD do or do not adhere to prescribed medications, whilst identifying barriers and what is helpful for adherence. IBD charities, e.g: Crohn's and Colitis UK(CCUK) and IBD health services will support in recruiting PLwIBD. Phase1b: A questionnaire will be developed to investigate 100 PLwIBDs' experiences with medication and adherence, as well as why non-adherence occurs. Phase2: PLwIBD, healthcare professionals and charities will come together to develop an intervention based around prior-fellowship research, Phase1 findings and related-theories. This intervention will facilitate opportunities for PLwIBD to seek information with support and guidance to encourage and promote adherence.Phase3: 15 PLwIBD will be recruited to test the intervention for 8weeks. Patients' will be asked to complete questionnaires before and after the intervention and will be interviewed afterwards. By doing this, we will find out if the intervention is acceptable to patients and if a larger study is needed to test its efficacy. Patient and Public Involvement(PPI) Involvement of patients and public for preparing this research has been on multiple levels: i)The researcher created an advert to recruit PPI attendees, which was uploaded to CCUK and Bowel Research UK websites and tweeted on Twitter. Five informal virtual groups were held for feedback on: -this summary, -adherence-support interventions they thought would be helpful, -who would best deliver such interventions, and -preferred delivery route(eg: website, telephone, face-to-face). Feedback has been incorporated into this 'Plain English Summary' and intervention design. ii)PPI participants and CCUK agreed to be part of the PPI group for this research, representing PLwIBD. In addition: iii)The researcher networked with PLwIBD, Gastroenterologists, Psychologists, Researchers, Pharmacists and Nurses to explore the need for adherence support for PLwIBD and develop a research plan. iv)The Black Asian and Minority Research Advisory Group provided advice to ensure the research represented all PLwIBD. iv)The researcher liaised with IBD charities CCUK and Bowel Research UK, gaining feedback on the proposed research. Dissemination Throughout the fellowship, the researcher will collaborate with stakeholders(PLwIBD, healthcare professionals and charities) sharing findings of all study phases at conferences, in oral and poster presentations, publications to relevant, high-impact journals and locally at clinical and academic meetings. Work will also be publicised in CCUK newsletters and websites and a plain English summary of findings will be available to participants and the public.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: ORAL AND GASTROINTESTINAL