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ACTIVE NOT RECRUITING
NCT05316584
NA

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

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

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.

Official title: A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With Inflammatory Bowel DiSease Therapy-ASSIST Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

123

Start Date

2022-09-06

Completion Date

2026-03-31

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

BEHAVIORAL

Remote monitoring

See prior description of the intervention.

Locations (5)

University of Maryland School of Medicine

Baltimore, Maryland, United States

New York University

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States