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

Area of Science:

• Gastroenterology and Hepatology
• Nursing Research
• Digital Health

Background:

• Inflammatory bowel disease (IBD) presents significant symptom burden despite pharmacological treatments.
• Limited non-pharmacological self-management options exist for IBD patients.
• A modified comprehensive self-management (CSM-IBD) intervention, adapted from irritable bowel syndrome protocols, has been developed.

Purpose of the Study:

• To determine the feasibility and acceptability of the CSM-IBD intervention and study procedures.
• To evaluate the preliminary efficacy of CSM-IBD on quality of life and daily symptoms.
• To explore associations between socioecological, clinical, and biological factors and symptom response.

Main Methods:

• A pilot randomized controlled trial (RCT) involving 54 participants aged 18-75 with at least two symptoms.
• Participants randomized 2:1 to CSM-IBD (8 sessions over 8-12 weeks with RN check-ins) or usual care.
• Outcomes assessed at baseline, post-intervention, and 3-month follow-up, focusing on feasibility, acceptability, quality of life, and symptoms.

Main Results:

• Recruitment initiated in February 2023, with 4 participants enrolled by April 2023.
• The study is funded by the National Institutes of Nursing Research and IRB-approved.
• Full study completion is anticipated by March 2025.

Conclusions:

• This pilot study will establish the feasibility and preliminary efficacy of a web-based, nurse-supported self-management intervention for IBD symptom improvement.
• Long-term goals include validating the intervention for enhanced patient quality of life and reduced healthcare costs.
• The intervention aims for cultural appropriateness and accessibility, particularly for rural and underserved populations.