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.

ondon North West University Healthcare NHS Trust0 sites780 target enrollmentSeptember 9, 2019

Overview

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34344432/ (added 03/09/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35583924/ Describing intervention development (added 20/05/2022) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38997767/ risk assessment protocol (added 16/07/2024)

Registry

who.int

Start Date

September 9, 2019

End Date

March 24, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

ondon North West University Healthcare NHS Trust

•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