Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease
Recruiting · NCT07456566 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Michigan
View the official record on ClinicalTrials.gov →Interventions studied
Digital self-management programStandard Care
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- University of Micigan - Ann Arbor, Michigan, United States
- University of Micigan - Ann Arbor, Michigan, United States