Self-management program to improve health in inflammatory bowel disease
Official title: Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial
Run by University of Michigan · NCT07456566 · Data updated 2026-11-12
A digital self-management program is being tested to see if it helps people with inflammatory bowel disease feel better and manage their symptoms alongside standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | July 20, 2026 |
| Main results expected | March 2028 |
| Study ends | March 2028 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07456566 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with active inflammatory bowel disease (Crohn's disease or ulcerative colitis) who have impaired health-related quality of life and can access the internet.
✕Probably not a fit
Patients with limited internet access, language barriers, or those with conditions requiring imminent surgery may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study tests a digital self-management program for patients with inflammatory bowel disease, comparing it to standard care. It focuses on whether changing daily behaviors can improve health-related quality of life and disease-related outcomes. Recruitment aims for about 10 participants every 3 months, with retention and data collection targets around 70% at 24 weeks. The trial measures include adherence to the intervention, usability, and health-related quality of life metrics. It is led by the University of Michigan with NIDDK collaboration, and internet access is required for participation.
Why it matters
Potential benefit: If successful, participants may experience improved quality of life and better disease management through accessible digital support.
How similar studies have gone: Prior studies of digital self-management in chronic diseases have shown mixed to positive outcomes; this study focuses specifically on IBD.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Inflammatory Bowel Disease (IBD) based on conventional clinical, endoscopic, and histopathological criteria, clinically active IBD * Impaired health-related quality of life * Clinically active IBD will be indicated by both a modified Harvey Bradshaw Index (HBI) ≥5 for Crohn's disease (CD) or a Simple Clinical Colitis Activity Index (SCCAI) ≥3 for ulcerative colitis (UC) * Fecal calprotectin \> 250 microgram (ug/g) * Impaired IBD-specific health-related quality of life will be defined as a Short IBD Questionnaire score ≤ 60 Exclusion Criteria: * Unable to speak and read English * Unable to access the internet regularly by phone or web as this will impair participants ability to engage with the intervention components * Have an ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses * Are planned for imminent surgery * Have short bowel syndrome * Uncontrolled medical or psychiatric disease
Where it's running
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University of Micigan
Ann Arbor, Michigan, United States Recruiting
Study contacts
- Principal investigator: Shirley Cohen-Mekelburg, MD, MS — University of Michigan
- Study coordinator: Shirley Cohen-Mekelburg, MD, MS
- Email: shcohen@med.umich.edu
- Phone: 734-845-5735
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is trying to learn more about gut inflammation in kids with inflammatory bowel diseases by collecting health information and samples from them and comparing it to kids who have different gut issues but no inflammation.
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Switching to subcutaneous infliximab for IBD treatment
This study is testing if switching people with inflammatory bowel disease from an intravenous form of infliximab to a subcutaneous version, given weekly or bi-weekly, can lead to better health results.
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Analyzing genetic factors in inflammatory bowel disease across different populations
This study is trying to find out how genes and the environment affect inflammatory bowel disease by looking at samples from people with the condition and healthy individuals.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.