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.
Inflammatory Bowel Disease (IBD)
Current intervention as of 19/07/2022: A pragmatic multi-centre two-arm, parallel group superiority RCT, with an internal pilot, of facilitator-supported online self-management versus care as usual to manage symptoms of fatigue, pain, and faecal urgency/incontinence in IBD. One baseline assessment and two assessments at 6 and 12 months after randomisation. Primary outcome: IBD-related quality of life and global rating of symptom relief at 6 months. This trial will compare a web-based programme, known as 'BOOST', for self-management of pain, fatigue and urgency/incontinence symptoms of IBD ('BOOST' is based on the principles of cognitive behavioural therapy with telephone and online messaging support) to standard care. The content has been developed by health psychologists to be interactive and tailored to patients’ needs. BOOST includes 11 online sessions which can be viewed on computer, smart phone or tablet.). Sessions 1-6, are core transdiagnostic sessions to be completed by participants experiencing fatigue, pain and faecal urgency/incontinence. Based on a Cognitive Behavioural model of IBD symptoms, the core sessions cover topics around: understanding IBD symptoms, balancing activity and exercise, sleep hygiene, changing negative thoughts, coping with stress and emotions, and making the most of social support. Sessions 7-11 are symptom-specific sessions to be completed by participants experiencing or with a specific interest in fatigue, pain and faecal urgency/incontinence, respectively. The symptom specific sessions provide participants with more in-depth psychoeducation on the interaction between medical and psychosocial factors contributing to the severity and impact of IBD symptoms, together with practical tips and exercises on how to better manage them. Participants will be able to log into BOOST via a computer, tablet or smartphone, according to their preference, and complete approximately one session per week. Each session takes 30-60 minutes to com
1. Diagnosis of IBD (self-reported as having been medically diagnosed with IBD including patients with an ileo-anal pouch or stoma) 2. 18 years old or over 3. Living in England, Scotland or Wales 4. Have participated in Stage 2 of the programme (IBD-BOOST survey) and have self-scored one or more symptoms of fatigue, pain or urgency/incontinence as having an impact on their life of 5 or more on a 0-10 scale when completing Stage 2 (IBD-BOOST survey) or Stage 3 (medical symptom optimisation) (whichever is the more recent) 5. No “red flags”– see below 6. Access to the online intervention via a computer or mobile device Screening for 'red flags': Following consent, we will screen patients for ’red flags’ (such as new bleeding, rapid weight loss or vomiting that has not been previously reported to a health care practitioner) self-reported on a screening checklist. Note: The “red flags” criteria have been developed in consultation with 5 consultant gastroenterologists who are either co-applicants or part of our wider advisory group: they have each confirmed that they feel that participants who meet the criteria will be safe to enter an online self-management programme. If ineligible because of a red flag, a participant may be re-assessed if they contact the research team and report the information they have provided has changed such as the symptom has been adequately investigated or managed, in which case the participant can be included.
1. One or more “red flags” identified on pre-randomisation screening, (such as new bleeding, rapid weight loss or vomiting that has not been previously reported to a health care practitioner) self-reported on a screening checklist. Note: The “red flags” criteria have been developed in consultation with 5 consultant gastroenterologists who are either co-applicants or part of our wider advisory group: they have each confirmed that they feel that participants who meet the criteria will be safe to enter an online self-management programme. If ineligible because of a red flag, a participant may be re-assessed if they contact the research team and report the information they have provided has changed such as the symptom has been adequately investigated or managed, in which case the participant can be included. 2. Inability to give informed consent (for example, due to reduced mental capacity) 3. Insufficient command of English to understand study documents and procedures