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Recruiting NCT07456566

Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease

Conditions: Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: University of Michigan

Location: University of Micigan Ann Arbor Michigan

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

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07456566). StuddyBuddy aggregates publicly available trial information.