A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial

JMIR Research Protocols · 10 authors, 5 centres

AI SUMMARY

FIDELITY 100%

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

“

TL;DR

No efficacy results are reported; the study aims to inform a future full-scale trial.

Full summary

776 CHARS

Primary outcomes assess feasibility (recruitment, randomization, data and sample collection) and acceptability of study procedures and the intervention. Secondary analyses examine preliminary efficacy on quality of life and symptoms, as well as associations among socioecological, clinical, and biological factors including gut microbiome signatures. The study was funded in April 2022 and recruitment began February 2023, with 4 participants enrolled as of April 2023. No efficacy or feasibility results have been reported. Key limitations include recruitment from a single academic medical center and potential self-selection bias, which may limit generalizability. If feasible and acceptable, findings will inform a full-scale trial incorporating diverse practice settings.

STUDY TYPE

RCT

SPECIALTY

gastroenterology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10285620

A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial

JMIR Research Protocols

READ THE FULL PAPER

ABSTRACT

Abstract Background Despite pharmacological treatment, individuals with inflammatory bowel disease (IBD) experience a variety of symptoms, including abdominal pain, fatigue, anxiety, and depression. Few nonmedical 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 those of individuals with IBD. We created a modified CSM intervention tailored to individuals with IBD (CSM-IBD). The CSM-IBD is an 8-session program delivered over 8-12 weeks with 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 controlled 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. Participants aged 18-75 years who are experiencing at least 2 symptoms are eligible for inclusion. We plan to enroll 54 participants who will be randomized (2:1) into the CSM-IBD program or usual care. Patients in the CSM-IBD program will have 8 intervention sessions. Primary study outcomes include the feasibility of recruitment, randomization, and data or sample collection, as well as the acceptability of study procedures and interventions. Preliminary efficacy outcome variables include quality of life and symptoms. Outcomes data will be assessed at baseline, immediately post intervention, 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’s institutional review board. Recruitment began in February 2023. As of April 2023, we have enrolled 4 participants. We expect the study to be completed by March 2025. Conclusions This pilot study will evaluate the feasibility and efficacy of a self-management intervention (a web-based program with weekly check-ins with a registered nurse) that aims to improve symptom management in individuals with IBD. In the long term, we aim to validate a self-management intervention to improve patient quality of life, reduce direct and indirect costs related to IBD, and be culturally appropriate and accessible, particularly in rural and underserved communities. Trial Registration ClinicalTrials.gov NCT05651542 ; https://clinicaltrials.gov/ct2/show/ NCT05651542 International Registered Report Identifier (IRRID) PRR1-10.2196/46307 Keywords: inflammatory bowel disease, self-management, symptom management, pilot, intervention, randomized controlled trial

CITATION EXPORT

Kendra Kamp, Kindra Clark-Snustad, Linda Yoo et al.. A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial. JMIR Research Protocols. (2023). https://doi.org/10.2196/46307

AUTHORS

10 · 5 CENTRES

Kendra Kamp, Kindra Clark-Snustad, Linda Yoo, Samantha Winders, Kevin Cain, Rona L Levy, Neelendu Dey, Scott Lee, Laurie Keefer, Margaret Heitkemper

1Department of Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Seattle, WA, United States
2Division of Gastroenterology, School of Medicine, University of Washington, Seattle, WA, United States
3School of Social Work, University of Washington, Seattle, WA, United States
4Fred Hutchinson Cancer Center, Seattle, WA, United States
5Mount Sinai, New York, NY, United States