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