NCT07210580 Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease
| NCT ID | NCT07210580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Inflammatory Bowel Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2028-12-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2026-03-09 with a primary completion date of 2028-12-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Shirley Cohen-Mekelburg, MD MS
PRINCIPAL INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Frequently Asked Questions
Who can join the NCT07210580 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07210580 currently recruiting?
Yes, NCT07210580 is actively recruiting participants. Contact the research team at Shirley.Cohen-Mekelburg@va.gov for enrollment information.
Where is the NCT07210580 trial being conducted?
This trial is being conducted at Decatur, United States, Ann Arbor, United States, Portland, United States, Houston, United States.
Who is sponsoring the NCT07210580 clinical trial?
NCT07210580 is sponsored by VA Office of Research and Development. The principal investigator is Shirley Cohen-Mekelburg, MD MS at VA Ann Arbor Healthcare System, Ann Arbor, MI. The trial plans to enroll 250 participants.