IBD-BOOST TRIAL
Research type
Research Study
Full title
A Randomised Controlled Trial of supported online self-management for symptoms of fatigue, pain and urgency/incontinence in people with inflammatory bowel disease: the IBD-BOOST trial
IRAS ID
258725
Contact name
Christine Norton
Contact email
Sponsor organisation
London North West Healthcare NHS Trust
Duration of Study in the UK
2 years, 10 months, 30 days
Research summary
Research Summary
Inflammatory Bowel Disease (IBD) affects 300,000 people in the UK , causing unpredictable bouts of gut inflammation, with acute illness, diarrhoea, and pain. In remission, many people with IBD live with fatigue, chronic abdominal pain, and bowel urgency/incontinence. 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%) even when IBD is in remission. These symptoms limit peoples’ quality of life and ability to work and socialise. Patients feel that these symptoms are not taken seriously by health professionals and report that little help is given. However, the James Lind Alliance IBD research priority-setting consensus put fatigue, pain, and continence in the top 10 issues that IBD patients and clinicians want to be addressed by research.
The IBD-BOOST programme of research
The current application is stage four of IBD-BOOST, a National Institute of Health Research (NIHR) Programme Grant for Applied Research (PGfAR) funded programme. The overall aim of the Programme Grant is to improve the quality of life of people with IBD by reducing the burden of IBD-related fatigue, abdominal pain, and urgency/incontinence.The current application is for the final part of the project, a 2-arm randomised controlled trial (RCT) of a facilitator-supported online intervention for people who have expressed a desire for intervention for fatigue, pain and/or urgency/incontinence, compared to care as usual.
Summary of Results
Background: Many people with Inflammatory Bowel Disease (IBD) experience fatigue, pain and faecal incontinence, impacting their quality of life. We developed an interactive digital online self-management intervention (IBD-BOOST) based on a theoretically informed logic model and cognitive behavioural techniques, to treat these symptoms. We aimed to assess if IBD-BOOST, alongside health care professional support and care as usual, provides greater relief from symptoms and improvement of quality of life compared with care as usual alone.Methods: We conducted a randomised-controlled trial with 4 participating NHS sites, and sent out postal and email invites to participate to people who had completed a previous IBD-BOOST Survey. Those invited had rated the impact of one or more IBD-related symptoms of fatigue, pain and/or urgency as 5 or more out of 10, and had indicated that they would be interested in receiving support.
After consenting, participants completed a general health assessment and a baseline questionnaire, and were then randomised into 1 of 2 groups. Participants randomised to the IBD-BOOST arm of the trial received 6 months access to the 12-session online IBD-BOOST programme, a 30-minute telephone support call with a trained health care professional after completing session 1, and weekly in-site messages from the health care professional for 3 months. Those randomised to the care as usual group received access to the IBD-BOOST programme without support after 12 months.
The dual primary outcome measures for the trial were the UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and global rating of symptom relief (GRSR) at 6 months after randomisation. Other secondary outcomes measures, including individual symptoms, were measured at 6 and 12 months, and there was also process evaluation work to determine whether the intervention was implemented as as intended and worked (or not) in the way expected.
Results: 780 participants were randomised, 432 people with Crohn’s disease and 348 with ulcerative colitis or other IBD. 520 (66.7%) were female, with a mean age of 49 years. At 6 months, both the UK-IBDQ and GRSR scores were similar between the IBD-BOOST intervention and care as usual arms. Adverse health events were similar between groups. Faecal incontinence and EQ5D quality of life scores (which were secondary outcomes) were significantly in favour of IBD-BOOST at 6 months, but pain and fatigue were no different.
57% of the IBD-BOOST group completed a pre-defined minimum “dose” of 4 sessions, and were identified as 'compliers' with the intervention. A Complier Average Causal Effect (CACE) analysis suggested that compliers were more likely to report better quality of life. Additionally, a subgroup analysis of those meeting the criteria for irritable bowel syndrome (IBS) showed that IBD-BOOST was more effective in improving UK-IBDQ and GRSR scores at 6-months when compared with care as usual for this group.
Discussion: This large randomised-controlled trial found that IBD-BOOST did not improve IBDQ and GRSR scores in patients with IBD and fatigue, pain and/or faecal incontinence, relative to the care as usual group. Participants did report less faecal incontinence at 6 and 12 months, and those who complied with the intervention showed a more pronounced IBDQ treatment effect. Those with IBD-IBS at baseline improved significantly more than those without, suggesting a possible for further effectiveness research on IBD-BOOST.
REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/0750
Date of REC Opinion
16 Jul 2019
REC opinion
Further Information Favourable Opinion