Recruiting

Self-Management Program

Sponsor:

University of Michigan

Code:

NCT07456566

Conditions

Inflammatory Bowel Diseases

Ulcerative Colitis

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital self-management program

Standard Care

Study Details

Brief 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

Conditions

Inflammatory Bowel Diseases

Ulcerative Colitis

Crohn Disease

Study ID

NCT07456566

Start date

Jul 20, 2026

Status verified date

Jul, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard care

Care as usual

experimental: Standard Care plus digital self-management program

24-week digital self-management program

Interventions

Digital self-management program

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

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.

Primary outcome measure

  • Participant recruitment rate [ Time Frame: 2 years (during the recruitment period) ]
  • The proportion of enrolled participants that complete the study without dropout [ Time Frame: 24 weeks ]
  • The proportion of study assessments completed by the participant [ Time Frame: 24 weeks ]
  • Qualitative interviews - self-management program group [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Shirley Cohen-Mekelburg, MD, MS

734-845-5735shcohen@med.umich.edu

Locations

University of Micigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Shirley Cohen-Mekelburg, MD, MS

734-845-5735shcohen@med.umich.edu

Principal Investigator:

Shirley Cohen-Mekelburg, MD, MS

More Information

Sponsor

University of Michigan

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Digital self-management program
  • Standard of care
  • Randomization
  • Questionnaires

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-23.