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Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial

Research output: Contribution to journalArticlepeer-review

Christine Norton, Jonathan Syred, Sally Kerry, Micol Artom, Louise Sweeney, Ailsa Hart, Wladyslawa Czuber-Dochan, Stephanie J C Taylor, Borislava Mihaylova, Chris Roukas, Qasim Aziz, Laura Miller, Richard Pollok, Sonia Saxena, Imogen Stagg, Helen Terry, Zohra Zenasni, Lesley Dibley, Rona Moss-Morris

Original languageEnglish
Article number516
JournalTrials
Volume22
Issue number1
DOIs
Accepted/In press16 Jul 2021
Published3 Aug 2021

Bibliographical note

Funding Information: We are grateful to all the involvement from people with IBD and to Crohn?s & Colitis UK who have supported the development of the intervention and outcome measures. London North West University Healthcare NHS Trust (R&D reference: RD19/001). Contact: Simon Lewis (simon.lewis4@nhs.net). The funder and sponsor will not play a role in study design, data collection and management, analysis and interpretation of data and writing the report and decision to submit for publication. The sponsor owns the data arising from the study and the CI will act as the custodian of this data on behalf of the sponsor. On completion of the study, a full report will be published by the funder in addition to peer-reviewed publications. The funding body (NIHR) will be acknowledged within the publications and review draft publications before journal submission. The day-to-day management of the study will be co-ordinated through the IBD-BOOST programme manager in collaboration with the CI, and through the Programme Management Group. The Programme Management Group (PMG) includes all co-investigators of the IBD-BOOST programme as well as the research team. The PMG and research team are responsible for the planning, execution, analysis and writing up the project. The programme is overseen by a Programme Steering Committee whose members are independent of the programme and liaise with the study funders, the NIHR. In the case of study deviations or serious breaches of protocol, study deviation forms will be completed and forwarded to the programme steering committee and the study sponsor. Regarding the data monitoring committee, it is not considered necessary to have such a committee for this low-risk trial. The Programme Steering Committee will act in this capacity if needed and includes an independent statistician. The patient and public involvement (PPI) team is responsible for contributing to development of all patient-facing materials and for co-analysing data generated. Laura Miller, Programme Manager. l.miller@qmul.ac.uk. +?44 (0)207 848 3318. King?s College London, 57 Waterloo Road London SE1 8WA. Professor Christine Norton, Chief Investigator. Christine.norton@kcl.ac.uk. +?44 (0)207 848 3864. King?s College London, 57 Waterloo Road London SE1 8WA. Funding Information: The funding document is in Additional file . UK National Institute of Health Research (Programme Grant Ref number RP-PG-0216-20001). ST is supported by the National Institute for Health Research ARC North Thames. Funding Information: The current Randomised Controlled Trial (RCT) is stage 4 of IBD-BOOST, a UK National Institute for Health Research (NIHR) Programme Grant for Applied Research (PGfAR) funded programme (grant reference RP-PG-0216-20001). This programme aims to improve the quality of life of people with IBD by reducing the burden of IBD-related fatigue, abdominal pain and urgency/incontinence. Table shows the four stages of the IBD-BOOST programme including this RCT. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

King's Authors

Abstract

BACKGROUND: Despite being in clinical remission, many people with inflammatory bowel disease (IBD) live with fatigue, chronic abdominal pain and bowel urgency or incontinence that limit their quality of life. We aim to test the effectiveness of an online self-management programme (BOOST), developed using cognitive behavioural principles and a theoretically informed logic model, and delivered with facilitator support.

PRIMARY RESEARCH QUESTION: In people with IBD who report symptoms of fatigue, pain or urgency and express a desire for intervention, does a facilitator-supported tailored (to patient needs) online self-management programme for fatigue, pain and faecal urgency/incontinence improve IBD-related quality of life (measured using the UK-IBDQ) and global rating of symptom relief (0-10 scale) compared with care as usual?

METHODS: A pragmatic two-arm, parallel group randomised controlled trial (RCT), of a 12-session facilitator-supported online cognitive behavioural self-management programme versus care as usual to manage symptoms of fatigue, pain and faecal urgency/incontinence in IBD. Patients will be recruited through a previous large-scale survey of unselected people with inflammatory bowel disease. The UK Inflammatory Bowel Disease Questionnaire and global rating of symptom relief at 6 months are the co-primary outcomes, with multiple secondary outcomes measured also at 6 and 12 months post randomisation to assess maintenance. The RCT has an embedded pilot study, health economics evaluation and process evaluation. We will randomise 680 patients, 340 in each group. Demographic characteristics and outcome measures will be presented for both study groups at baseline. The UK-IBDQ and global rating of symptom relief at 6 and 12 months post randomisation will be compared between the study groups.

DISCUSSION: The BOOST online self-management programme for people with IBD-related symptoms of fatigue, pain and urgency has been designed to be easily scalable and implemented. If it is shown to improve patients' quality of life, this trial will enable clinicians and patients to make informed management decisions. This is the first trial, to our knowledge, focused on multiple symptoms prioritised by both people with IBD and health professionals.

TRIAL REGISTRATION: ISRCTN71618461 . Registered on 9 September 2019.

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