Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease
Not applicable · Testing Digital self-management program and Standard Care · 1 site · University of Michigan
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Digital self-management program (a behavioral program) and Standard Care (a behavioral program) as a possible treatment. Condition(s) listed: Inflammatory Bowel Diseases, Ulcerative Colitis and Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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)
Plus 2 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2026-07-20.
- Main results expected around 2028-03 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Participant recruitment rate (2 years (during the recruitment period))
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease |
| Lead sponsor | University of Michigan |
| Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Enrollment | 40 (estimated) |
| Start date | 2026-07-20 |
| Primary completion (est.) | 2028-03 |
| First posted | 2026-03-06 |
| Last updated | 2026-07-23 |
| Official title | Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial |
| ClinicalTrials.gov ID | NCT07456566 |
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 skil… - 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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Micigan | Ann Arbor, Michigan | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.