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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Digital self-management program
  • Standard Care

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Michigan

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator