A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy (NCT05316584)
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With Inflammatory Bowel DiSease Therapy-ASSIST Study
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Maryland School of Medicine โ Baltimore, Maryland
Age range: 18 Years to 80 Years
๐งช Interventions in This Study
- Remote monitoring (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (5 Sites)
- University of Maryland School of Medicine โ Baltimore, Maryland
- New York University โ New York, New York
- University of North Carolina at Chapel Hill โ Chapel Hill, North Carolina
- University of Cincinnati College of Medicine โ Cincinnati, Ohio
- Vanderbilt University Medical Center โ Nashville, Tennessee
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Inflammatory Bowel Diseases
- Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care โ Vancouver, British Columbia
- PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFฮฑ Crohn's Disease ThErapy in Children: The PROMOTE Trial โ Ottawa, Ontario
- Outpatient VR (Virtual Reality)-Brain-gut Behavioral Therapies (BGBT) in Inflammatory Bowel Disease (IBD) โ Ann Arbor, Michigan
- A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease โ Lancaster, California
- A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC โ Sun City, Arizona
Explore by condition: All Inflammatory Bowel Diseases clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.