Inflammatory Bowel Disease (IBD) Digestive System Inflammatory Bowel Disease (IBD)
Conditions
Interventions
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
Sponsors
London North West University Healthcare NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and global rating of symptom relief at six months after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) at 12 months 2. Rating of satisfaction with results of BOOST programme (simple 0-100 visual analogue scale) at 6 and 12 months only 3. Global rating of symptom relief at 12 months 4. Numerical (0-10) pain rating scale at baseline, 6 and 12 months after randomisation 5. Vaizey (faecal) incontinence score, reflecting patients’ perceptions of severity at baseline, 6 and 12 months after randomisation 6. IBD-Fatigue score at baseline, 6 and 12 months after randomisation 7. IBD-Control score; 8-item self-reported score to measure disease control from the patient's perspective at baseline, 6 and 12 months after randomisation 8. EQ-5D-5L general health-related quality of life at baseline and 6 and 12 months after randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactLaura Miller
Outcome results
None listed