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Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease
Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for inflammatory bowel disease. This research will increase the understanding of the role of a self-management program in improving health and health-related quality of life for patients with inflammatory bowel disease.
The study team hypothesizes:
* the study will achieve a recruitment rate of 10 participants every 3 months * 70% participant retention at 24 weeks * 70% outcome data collection * 70% intervention completion * high acceptability
What is being tested
- Digital self-management program (behavioral)
- Standard Care (behavioral)
Sponsor: University of Michigan · Participants: 40 · Started: Jul 20, 2026
Contact the study team
- Shirley Cohen-Mekelburg, MD, MS · Phone: 734-845-5735
Official record on ClinicalTrials.gov — NCT07456566
Locations in the U.S.
| Michigan | University of Micigan, Ann Arbor |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.