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Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
University of Micigan
RECRUITING
Ann Arbor
Contact Information
Primary
Shirley Cohen-Mekelburg, MD, MS
shcohen@med.umich.edu
734-845-5735
Time Frame
Start Date: 2026-07-20
Estimated Completion Date: 2028-03
Participants
Target number of participants: 40
Treatments
Active_comparator: Standard care
Care as usual
Experimental: Standard Care plus digital self-management program
24-week digital self-management program
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Michigan

This content was sourced from clinicaltrials.gov