Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease
Recruiting now · Not applicable
Conditions studied: Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
In brief
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
Key facts
- Study ID
- NCT07456566
- Run by
- University of Michigan
- People needed
- 40
- Starts
- 2026-07-20
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- University of Micigan — Ann Arbor, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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