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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07456566
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Digital self-management program — BEHAVIORAL
    Participants will receive this 24-week digital self-management program that was developed for patients with inflammatory bowel disease in addition to standard care. The program will be accessed through the web or a mobile device and will include different modules that will help support in managing participant's symptoms and disease both in the short-term as well as helping to build habits and skills to support participants in managing disease long-term. Participants are not required to use the self-management program and may stop using it at any time without any penalty to standard inpatient treatment. Additionally, participants will be asked to complete a follow-up self-report questionnaire at week 8 and week 12, and a clinician assessment at week 12. After 24 weeks a final remote visit or video meeting will be completed.
  • Standard Care — BEHAVIORAL
    Participants will have baseline assessment of symptoms both based on self-report and a clinician's assessment, and review the electronic health record for standard of care inflammatory biomarker measurements. In addition, questionnaires will be collected and visit completed at 8,12, and 24-week follow-ups.

Study Details

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

Key Dates

First listed
Mar 6, 2026
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard care
    Care as usual
  • Experimental: Standard Care plus digital self-management program
    24-week digital self-management program

Primary Outcome Measure

Participant recruitment rate [ Time Frame: 2 years (during the recruitment period) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiciganAnn ArborMichigan48109
Shirley Cohen-Mekelburg, MD, MS
[email protected]
734-845-5735
Shirley Cohen-Mekelburg, MD, MS (PRINCIPAL_INVESTIGATOR)

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Crohn's diseaseUlcerative colitis
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GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
University of Micigan· Ann Arbor, MI

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