Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 17, 2023
Date Accepted: Apr 30, 2023
A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial
ABSTRACT
Background:
Despite pharmacological treatment, individuals with inflammatory bowel disease (IBD) experience a variety of symptoms including abdominal pain, fatigue, anxiety, and depression. Few non-medical self-management interventions are available for people with IBD. A validated comprehensive self-management (CSM) intervention is effective for patients with irritable bowel syndrome who can have symptoms similar to individuals with IBD. We created a modified CSM intervention tailored to individuals with IBD (CSM-IBD). The CSM-IBD is an 8-week online program with weekly check-ins with a registered nurse.
Objective:
The primary objective of this pilot study is to determine the feasibility and acceptability of study procedures and the CSM-IBD intervention and to evaluate preliminary efficacy on quality of life and daily symptoms for a future randomized control trial. Additionally, we will examine the association of socioecological, clinical, and biological factors with symptoms at baseline and response to intervention.
Methods:
We are conducting a pilot randomized controlled trial of the CSM-IBD intervention. We plan to enroll 54 participants who will be randomized (2:1) into the CSM-IBD program or usual care. Outcomes data will be assessed at baseline, immediately post, and 3-months post intervention. Participants in the usual care group will have access to the intervention after study participation.
Results:
This project is funded by the National Institutes of Nursing Research and reviewed by the University of Washington IRB. Recruitment is set to begin February 2023.
Conclusions:
This pilot study will evaluate the feasibility and efficacy of a self-management intervention (online program with weekly check-ins with a registered nurse) that aims to improve symptom management in individuals with IBD. Long term, we aim to validate a self-management intervention will improve patient quality of life, reduce direct and indirect costs related to IBD, and that is culturally appropriate and accessible, particularly in rural and underserved communities. Clinical Trial: ClinicalTrials.gov NCT05651542; https://clinicaltrials.gov/ct2/show/NCT05651542
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