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A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
NCT05316584 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- BEHAVIORAL Remote monitoring
Study Locations (5)
Maryland
- University of Maryland School of Medicine — Baltimore
New York
- New York University — New York
North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill
Ohio
- University of Cincinnati College of Medicine — Cincinnati
Tennessee
- Vanderbilt University Medical Center — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2022-09-06 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05316584
The ClinicalTrials.gov registry entry for NCT05316584 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 559 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention — of which Remote monitoring is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05316584 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Maryland, New York, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05316584 about?
NCT05316584 is a clinical study titled "A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy". 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 init...
What is the current status of trial NCT05316584?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 123 participants. The study started on 2022-09-06. Estimated completion is 2026-03-31.
What conditions does trial NCT05316584 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn Disease, Inflammatory Bowel Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05316584?
The interventions under investigation include: Remote monitoring (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05316584?
This trial is sponsored by University of Maryland, Baltimore, which has 559 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05316584 being conducted?
This trial has 5 study locations across Maryland, New York, North Carolina, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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