NCT07456566Recruiting
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 2 Mar 2026
- Start date
- 20 Jul 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- University of Michigan
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07456566
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 20 Jul 2026 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Are planned for imminent surgery
Other illness
- Have short bowel syndrome
- Uncontrolled medical or psychiatric disease
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Micigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.