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NCT05316584 · ClinicalTrials.gov record · last posted 2026-08-20

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy

Study acronym: ASSIST
StatusActive, Not Recruiting
PhaseNot applicable
Started2022-09-06
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from the ClinicalTrials.gov record
The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease initiating oral or subcutaneous treatment. The investigators are conducting a 12-month, multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization. The investigators will address the following specific aims: 1. Compare adherence as measured by the medication possession ratio in participants using a remote monitoring digital health system compared to standard of care. 2. Compare clinical outcomes and healthcare utilization in participants using a remote monitoring digital health system compared to standard of care.

Protocol amendment history 2 changes detected by DataLookout

2026-08-21
Primary completion pushed: 2026-03-31 → 2026-12-31
2026-08-21
Completion pushed: 2026-03-31 → 2026-12-31
Trial Details
NCT Number NCT05316584
Lead Sponsor University of Maryland, Baltimore
Collaborators: University of North Carolina, Chapel Hill, Vanderbilt University Medical Center, New York University, University of Cincinnati
Conditions Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
Enrollment 123 participants
Start Date 2022-09-06
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-20