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RECRUITING
NCT07210580
NA

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

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-03-09

Completion Date

2029-09-30

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

BEHAVIORAL

MBC-IBD Intervention

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 questionnaires (PROs) which will be completed by phone or electronically using VA REDCap. MBC in IBD will not replace but rather provide care continuity between clinic visits. Patients allocated to MBC in IBD will receive automated reminders to complete weekly questionnaires. Further, patients will receive quarterly reports of their PRO data trends.

OTHER

Enhanced Treatment as Usual (E-TAU)

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.

Locations (4)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States