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

Conditions

• Inflammatory Bowel Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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 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.
• 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.

Study Details

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.

Key Dates

Start date

Mar 9, 2026

Status verified

Mar 2026

Primary completion

Dec 29, 2028

Completion

Sep 30, 2029

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: MBC-IBD
  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. These assessments require completion of self-report questionnaires 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.
• Active Comparator: E-TAU
  Enhanced Treatment as Usual (E-TAU). Participants assigned to E-TAU will receive standard of care, including monitoring and treatment as directed at the discretion of their gastroenterologist. Standard of care is based on current evidence-based professional guidelines, including routine inflammatory biomarker assessments (e.g., annual fecal calprotectin), therapy plans, scheduled and as-needed clinic visits, and scheduled and as-needed telephone calls. Participants will also receive educational videos and fact sheets on various IBD-specific topics.

Primary Outcome Measure

Patient-reported Health-related Quality of Life [ Time Frame: Baseline compared to 12 month follow-up. ]

Central Contacts

• Shirley Cohen-Mekelburg, MD MS
  (734) 845-5082
  [email protected]
• Nicolle Marinec, MPH
  (734) 845-3653
  [email protected]

Locations (4)

Find similar trials in Decatur, GA

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