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NCT07210580 · ClinicalTrials.gov registry record · NA
Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease
A NA study of Inflammatory Bowel Disease, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 4
- Study locations
NCT07210580: Recruiting NA study of Inflammatory Bowel Disease, sponsored by VA Office of Research and Development.
NCT07210580 is a NA study of Inflammatory Bowel Disease that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 250 participants, below the 395-participant average among 28 other Inflammatory Bowel Disease trials with a reported enrollment target (37% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07210580, a NA study of Inflammatory Bowel Disease, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 4
- Study locations
Study Summary
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. However, it is difficult to closely monitor Veterans with IBD between clinic visits. There is a critical need for solutions that support close between visit monitoring of Veterans with IBD. The Measurement-Based Care (MBC) for IBD study will take a systematic approach to collect, share, and act on patient reported outcome (PRO) data that can be used to achieve close monitoring. MBC supports patients' in managing their condition and boosting their confidence in their ability to handle their symptoms and disease, and also supports care teams in early recognition of health issues. The investigators will work with both Veterans and their care teams to understand and assess this program so it can be a model for future initiatives.
Primary Outcome
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 depen
Conditions Studied
Interventions
- BEHAVIORAL MBC-IBD Intervention
- OTHER Enhanced Treatment as Usual (E-TAU)
Study Locations (4)
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
Michigan
- VA Ann Arbor Healthcare System, Ann Arbor, MI - Ann Arbor
Oregon
- VA Portland Health Care System, Portland, OR - Portland
Texas
- Michael E. DeBakey VA Medical Center, Houston, TX - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2026-03-09 |
| Est. Completion | 2029-09-30 |
| Phase | NA |
What NCT07210580 shows while recruiting
NCT07210580 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 395-participant average among 28 other Inflammatory Bowel Disease trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Inflammatory Bowel Disease appearing as the primary indexed condition, and to 2 interventions - of which MBC-IBD Intervention is the first listed.
NCT07210580 reports a single indexed study location in Georgia, Michigan, Oregon.
Frequently Asked Questions
What is clinical trial NCT07210580 about?
NCT07210580 is a clinical study titled "Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease". 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 q...
What is the current status of trial NCT07210580?
This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2026-03-09. Estimated completion is 2029-09-30.
What conditions does trial NCT07210580 study?
This clinical trial studies the following conditions: Inflammatory Bowel Disease.
What interventions are being tested in trial NCT07210580?
The interventions under investigation include: MBC-IBD Intervention (BEHAVIORAL), Enhanced Treatment as Usual (E-TAU) (OTHER).
Who is sponsoring clinical trial NCT07210580?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07210580 being conducted?
This trial has 4 study locations across Georgia, Michigan, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07210580's enrollment target sits among peer trials
250 10th of 28 higher than 18 of 28 other Inflammatory Bowel Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammatory Bowel Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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