NCT05316584Active, not recruiting
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With Inflammatory Bowel DiSease Therapy-ASSIST Study
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 123 (estimated)
- First submitted
- 17 Mar 2022
- Start date
- 6 Sept 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05316584
What you commit to
- Study type: Interventional
- Planned participants: 123
- From 6 Sept 2022 to the primary completion date, 31 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients initiating oral corticosteroids only (without concurrent use of an oral or subcutaneous maintenance therapy)
- Imminent surgery (within the next 60 days)
Other illness
- History of short bowel syndrome
- Uncontrolled medical or psychiatric disease at the opinion of the investigator
- Degenerative neurologic condition
- Unstable angina
- Symptomatic peripheral vascular disease
- Malignancy within the last 2 years (excluding squamous or basal cell cancers of the skin)
- Poorly controlled depression, mania, and schizophrenia
- Serious active infection requiring antimicrobial therapy (excluding CD patients with perianal CD on antibiotics)
Other
- Inability to speak and read English
- Inability to comply with the study protocol
- Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis
Who the study is looking for
- At least 18 years of age or older
- Have documented IBD based on usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology
- Initiating treatment with a new oral or subcutaneous treatment for IBD
- Have access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access
- Ability to understand the protocol and provide informed consent in English
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland School of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| University of Cincinnati College of Medicine Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| New York University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.