Title: Living well with inflammatory bowel disease: optimising management of symptoms of fatigue, abdominal pain, and faecal urgency/incontinence via tailored online self-management: the IBD-BOOST programme
Funder: Department of Health and Social Care

Abstract: Aim The aim of the research programme is to improve the quality of life of people with inflammatory bowel disease (IBD) by reducing the burden of symptoms of fatigue, abdominal pain, and faecal urgency/incontinence. Objectives Via four Work Packages (WPs) we will: Develop a theoretically-informed online self-management programme for IBD fatigue, abdominal pain and faecal urgency/incontinence, based on cognitive behavioural principles, our extensive previous work and reviews, input from people with IBD, and what is known to work for these symptoms in other conditions (WP1a). Develop an online training package for IBD nurses to provide telephone support alongside the online self-management programme (WP1b) Conduct a feasibility study to test the intervention developed (WP1c). Develop, in collaboration with people with IBD and expert clinicians, a checklist and management algorithm for potentially medically reversible causes of fatigue, abdominal pain and faecal urgency/incontinence in IBD (WP2a). Survey 12,600 people by brief postal questionnaire to determine what proportion have these symptoms and want help for them (WP2b). Test the checklist and algorithm in ~1,000 people with IBD who want help for symptoms, and determine what proportion have potentially reversible medical causes and if symptoms improve if these are addressed (WP 2c). Conduct a randomised controlled trial (RCT), with an internal pilot, of the intervention developed in WP1 comparing online tailored self-management plus IBD nurse support with care as usual in 680 people who have been screened and medical management has been optimised (if appropriate) in WP2c. Primary outcome at 6 months after randomisation is condition-specific quality of life; secondary outcomes include symptoms and potentially explanatory variables (6 and 12 months) (WP3a & 3b). Conduct health economics analysis to determine if the intervention is cost effective (WP3c). Conduct detailed process evaluation to understand how and why we obtained the results found in the RCT (WP3d). Disseminate our results widely via multiple communication channels and ensure people with IBD and NHS services benefit (WP4). Background and rationale Over 300,000 people in the UK have Inflammatory Bowel Disease (IBD), a lifelong, currently incurable condition, causing unpredictable bouts of gut inflammation. Modern medical management has made great advances in treating these bouts, reducing morbidity and mortality. However, even in remission many people with IBD report persisting troublesome symptoms of fatigue (41%) abdominal pain (62%) and faecal urgency/incontinence (up to 75%) which limit quality of life and ability to work and socialise. These symptoms have largely been neglected in both clinical care and research. People with IBD have embraced self-management of disease, including online interfaces to monitor disease activity. Online tailored self-management with clinician support improves pain and fatigue in other long term conditions but has not been tried in IBD. Our previous work, including developing face to face interventions and patient reported outcome measures for these symptoms in IBD and other conditions ideally places the team to develop and test a clinician-supported online intervention in IBD. Research Plan and methods See participant flow chart (Appendix 2). WP 1: Developing the online self-management intervention WP 1a: Focus group interviews (informing intervention development): 60-80 participants. Analysis by researchers and people with IBD, guided by the Analytical Hierarchy Framework. WP1b: Intervention development. Co-design of an online guided self-management programme. WP1c Feasibility testing of online intervention with 100 volunteers. WP 2: Identifying and optimising medical causes of symptoms WP2a: Checklist and algorithm development. Method: Modified Nominal Group Technique consensus process. WP2b: Postal questionnaire: sent to 12,500 unselected people with IBD from 15 centres with one reminder. WP2c: Optimising medical management. Method: Cohort study, where an IBD nurse uses the checklist and algorithm to guide investigations and interventions to treat medical factors possibly underlying symptoms for 3 months. Outcome measurement: quality of life, symptoms and global assessment of relief. WP 3: Randomised controlled trial WP3a: Internal pilot of 100 participants. WP3b: Randomised controlled trial: 680 participants using nurse-supported online self-management of symptoms (fatigue, pain, faecal urgency/incontinence) compared with care as usual. Primary outcome: condition-specific IBD validated quality of life 6 months after randomisation. Secondary end points: validated symptom questionnaires, global assessment of relief and satisfaction with outcome (6 and 12 months). Online self-completion of outcome measures. Blinded intention to treat analysis comparing the 2 groups at 6 months. WP3c: Health Economics evaluation to determine cost effectiveness from an NHS and personal perspective. WP3d: Process evaluation (mixed methods) to determine intervention fidelity, and explore explanations for results and lessons for dissemination. WP 4: Dissemination and embedding in the NHS and more widely Outputs and dissemination Dissemination led by Crohn s & Colitis UK: We plan 11 major outputs, including: the online programme (freely available); the checklist and algorithm for NHS use; training manuals for IBD nurses; peer review papers and conference presentations. Benefits to patients and the NHS People with IBD will have improved quality of life and ability to work and socialise.

Lay abstract: Aims To improve the well-being of people with inflammatory bowel disease (IBD) by relieving their most common and troublesome chronic symptoms (fatigue, abdominal pain, faecal urgency/incontinence), thus enhancing their quality of life. Background IBD affects 300,000 people in the UK, causing unpredictable bouts of gut inflammation, with acute illness, diarrhoea, and pain. There is no current cure for IBD, which usually starts in childhood or as a young adult. Most previous IBD research has focused on controlling inflammation. However, many people report continuing IBD-related fatigue (41%), abdominal pain (62%) and difficulty with continence (up to 75%) when in remission. These symptoms limit peoples quality of life and ability to work and socialise. Patients feel these symptoms are not taken seriously by health professionals and that little help is given. Little research has been done on how to improve these symptoms. Design and methods used Interviews with people with IBD will determine their priorities in relation to these symptoms, what they find helps, and their preferences and suggestions for interventions. Working with people with IBD and health professionals we will design a checklist to identify underlying medical causes for symptoms (e.g. anaemia causing fatigue). We will screen 1050 people who want help for symptoms using this checklist, and treat those with any causes found to see if symptoms and quality of life improve. We will work with people with IBD to co-design an online intervention for these symptoms. Those without medical causes for symptoms will enter a randomised trial comparing online self-management with IBD nurse support, or care as usual in 680 people. This will determine if supported online self-management improves quality of life and symptoms. Patient and public involvement People with IBD have prioritised these symptoms via a consensus exercise, and as evidenced by Crohn s & Colitis UK (CCUK) leading our previous work on IBD-fatigue and funding continence and online intervention studies. CCUK Policy lead (HT) and former Vice-Chair (AV) are co-applicants and have been closely involved in developing this application. Patients have worked with us on developing questionnaires for IBD-fatigue and incontinence and on checklists and interventions for fatigue, pain, distress and incontinence. They have suggested our outcome measures. We plan close partnership throughout the programme, with patients chairing our management and steering committees, patients participating in co-designing the intervention and leading dissemination. Dissemination Led by DM, Communications Manager at CCUK (social media reach 1million+ weekly). Apart from publications and conference presentations, there will be extensive outputs for patients, including a blog and twitter feed allowing people to follow our progress. We will develop a patient-friendly website, with a self-assessment checklist, which will eventually host the online intervention. See http://www.crohnsandcolitis.org.uk/about-inflammatory-boweldisease/publications/fatigue-ibd; http://s3-eu-west- 1.amazonaws.com/files.crohnsandcolitis.org.uk/Publications/managing-bowel-incontinence-in-IBD.pdf; and http://www.fatigueinibd.co.uk/ for previous collaborative outputs.

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