Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease
Not applicable · Testing MBC-IBD Intervention and Enhanced Treatment as Usual (E-TAU) · 4 sites · VA Office of Research and Development
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing MBC-IBD Intervention (a behavioral program) and Enhanced Treatment as Usual (E-TAU) to improve how care is delivered. Condition(s) listed: Inflammatory Bowel 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:
- receiving IBD care at one of the four sites
- reporting an impaired IBD-specific HRQOL using the Short IBD Questionnaire (SIBDQ<60, as used by others)
- willingness and ability to participate in study procedures
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 250 participants are expected to take part.
- Start date: 2026-03-09.
- Main results expected around 2028-12-29 (estimate from the record).
- 4 study sites listed (1 marked recruiting) in United States.
Main thing being measured
- Patient-reported Health-related Quality of Life (Baseline compared to 12 month follow-up.)
In the researchers’ words
This research study is addressing issues related to Inflammatory bowel disease (IBD), which is a chronic autoimmune disorder that affects over 60,000 Veterans. With close monitoring and timely treatment adjustment, the investigators can stop the natural progression of IBD, improving health-related quality of life (HRQOL) and reducing flares and hospitalizations.
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 Disease |
| Lead sponsor | VA Office of Research and Development |
| Enrollment | 250 (estimated) |
| Start date | 2026-03-09 |
| Primary completion (est.) | 2028-12-29 |
| First posted | 2025-10-07 |
| Last updated | 2026-03-11 |
| Official title | Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease: A Hybrid Effectiveness-Implementation Study |
| ClinicalTrials.gov ID | NCT07210580 |
Interventions
- MBC-IBD Intervention (Behavioral)
Measurement Based Care for Inflammatory Bowel Disease - Intervention group. Veteran participants who are randomized to 12-months of MBC-IBD will be enrolled for 12 months. They will each complete surveys at baseline, 6-months, and 12-months post-randomization. After baseline completion, participants will be asked to complete weekly surveys. These assessments require completion of self-report quest… - Enhanced Treatment as Usual (E-TAU) (Other)
E-TAU will receive standard of care, including monitoring and treatment as directed at the discretion of their gastroenterologist. Participants will also receive educational videos and fact sheets on various IBD-specific topics.
Full eligibility criteria (from the record)
Inclusion Criteria: Inclusion criteria for Veteran patients include: * receiving IBD care at one of the four sites * reporting an impaired IBD-specific HRQOL using the Short IBD Questionnaire (SIBDQ<60, as used by others) * willingness and ability to participate in study procedures Clinic staff criteria: * relevant clinic staff (gastroenterologists, advanced practice providers, nurses) involved in MBC in IBD at the four study sites (Ann Arbor, Atlanta, Houston, Portland). Exclusion Criteria: Veteran Patient Exclusion criteria: * Presence of an ostomy or ileal-pouch anal anastomosis * Severe comorbid medical condition that can confound PRO scores and treatment priorities (e.g., cancer, transplant). * Exclusions can be readily determined from chart review and a baseline patient assessment Clinic staff exclusion criteria: * Clinic staff without any experience with MBC in IBD.
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur, Georgia | United States | Not yet recruiting |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor, Michigan | United States | Recruiting |
| VA Portland Health Care System, Portland, OR | Portland, Oregon | United States | Not yet recruiting |
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston, Texas | United States | Not yet 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.