NCT07456566NARecruiting
Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease
University of Michigan
Start Date
7/20/2026
Completion Date
3/1/2028
Summary
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
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
BEHAVIORAL
Digital self-management program
BEHAVIORAL
Standard Care
Conditions
Inflammatory Bowel DiseasesUlcerative ColitisCrohn Disease
Locations
University of Micigan
Ann Arbor, Michigan 48109
United States