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

NCT05316584 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-02-24

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Remote monitoring

See prior description of the intervention.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • New York University

    collaborator OTHER

  • University of Cincinnati

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05316584 on ClinicalTrials.gov