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Testing Measurement-Based Care for Veterans with Inflammatory Bowel Disease

This study is testing a new approach called Measurement-Based Care (MBC-IBD) for Veterans with Inflammatory Bowel Disease (IBD). IBD is a long-term condition that affects over 60,000 Veterans. MBC-IBD aims to improve how your IBD is monitored between doctor visits by regularly collecting and using your health information. You might receive MBC-IBD or standard care with educational materials. The study wants to see if MBC-IBD can improve your quality of life related to your health over 12 months. To join, you must be a Veteran receiving IBD care at one of the four study sites, report a lower quality of life due to IBD, and be willing to participate. The study is currently unclear on its recruitment status and plans to enroll 250 Veterans.

Study design
This is an interventional study that will randomly assign 250 Veterans to either the MBC-IBD intervention or enhanced standard care.
What's involved
If you are in the MBC-IBD group, you will participate for 12 months and complete surveys at the start, 6 months, and 12 months. If you are in the enhanced standard care group, you will receive typical care and educational videos/fact sheets.
Compensation
Not stated in the trial record.
Follow-up
Your health-related quality of life will be measured at the beginning of the study and again at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07210580

Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease

Recruiting
NAAges 18+InterventionalHealth services
VA Office of Research and Development
~250 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:MBC-IBD InterventionEnhanced Treatment as Usual (E-TAU)

At a glance

Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient-reported Health-related Quality of Life
Measured over Baseline compared to 12 month follow-up.

Conditions

Inflammatory Bowel Disease

Explore related trials

Inflammatory Bowel Disease

Where it's being run

4 sites across 4 states
Georgia1
Michigan1
Oregon1
Texas1

Study leadership

  • Shirley Cohen-Mekelburg, MD MS · PRINCIPAL_INVESTIGATOR · VA Ann Arbor Healthcare System, Ann Arbor, MI

Who to contact

Shirley Cohen-Mekelburg, MD MS
[email protected]
(734) 845-5082
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
relevant clinic staff (gastroenterologists, advanced practice providers, nurses) involved in MBC in IBD at the four study sites (Ann Arbor, Atlanta, Houston, Portland).

Exclusion

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 without any experience with MBC in IBD.

What this trial measures

  • Patient-reported Health-related Quality of LifeBaseline compared to 12 month follow-up.

    Test the effectiveness of MBC vs. E-TAU on key patient outcomes, specifically looking at IBD-specific patient reported HRQOL (primary outcome). Assess IBD-specific HRQOL compared to E-TAU at 12-months follow-up. The investigators will first graphically explore the longitudinal data over time between the MBC and E-TAU groups. As the primary analytic model, the investigators will use an analysis of covariance (ANCOVA), fit using a linear regression model with SIBDQ score at 12 months as the dependent variable to estimate between-group differences in the primary endpoint. The model will include an indicator for treatment group (MBC vs. E-TAU) to estimate the 12-month treatment effect and adjust for baseline SIBDQ scores as a covariate and the stratification factors used for randomization (site, age, IBD type).