Norton, C;
Syred, J;
Kerry, S;
Artom, M;
Sweeney, L;
Hart, A;
Czuber-Dochan, W;
Taylor, SJC;
Mihaylova, B;
Roukas, C;
et al.
Norton, C; Syred, J; Kerry, S; Artom, M; Sweeney, L; Hart, A; Czuber-Dochan, W; Taylor, SJC; Mihaylova, B; Roukas, C; Aziz, Q; Miller, L; Pollok, R; Saxena, S; Stagg, I; Terry, H; Zenasni, Z; Dibley, L; Moss-Morris, R
(2021)
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.
Trials, 22 (1).
p. 516.
ISSN 1745-6215
https://doi.org/10.1186/s13063-021-05466-4
SGUL Authors: Pollok, Richard Charles G
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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.
Item Type: | Article | ||||||
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Additional Information: | © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | ||||||
Keywords: | Crohn’s disease, Faecal incontinence, Fatigue, Inflammatory bowel disease, Online self-management, Pain, RCT, Ulcerative colitis, Adult, Cognitive Behavioral Therapy, Fatigue, Humans, Inflammatory Bowel Diseases, Pain, Quality of Life, Randomized Controlled Trials as Topic, Self-Management, Humans, Inflammatory Bowel Diseases, Pain, Fatigue, Quality of Life, Adult, Randomized Controlled Trials as Topic, Self-Management, Cognitive Behavioral Therapy, RCT, Inflammatory bowel disease, Crohn's disease, Ulcerative colitis, Fatigue, Pain, Faecal incontinence, Online self-management, Cardiovascular System & Hematology, General & Internal Medicine, 1102 Cardiorespiratory Medicine and Haematology, 1103 Clinical Sciences | ||||||
SGUL Research Institute / Research Centre: | Academic Structure > Infection and Immunity Research Institute (INII) | ||||||
Journal or Publication Title: | Trials | ||||||
ISSN: | 1745-6215 | ||||||
Language: | eng | ||||||
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Publisher License: | Creative Commons: Attribution 4.0 | ||||||
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PubMed ID: | 34344432 | ||||||
Web of Science ID: | WOS:000683466700003 | ||||||
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URI: | https://openaccess.sgul.ac.uk/id/eprint/113589 | ||||||
Publisher's version: | https://doi.org/10.1186/s13063-021-05466-4 |
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