Condition: Inflammatory Bowel Disease (IBD) · Crohn's Disease · Ulcerative Colitis · Sponsor: Mercy Medical Center
The goal of this observational study is to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization in patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, and inflammatory bowel disease type undetermined) initiating therapy with vedolizumab (Entvyio). The main questions it aims to answer are: 1. Assess and compare adherence to intravenous (IV) and subcutaneous vedolizumab maintenance therapy in patients with IBD using a novel remote monitoring system. 2. Assess symptom response to vedolizumab post induction (week 6-8) and during maintenance therapy (week 22) using a novel remote monitoring system. 3. Assess time to response to vedolizumab during induction (weeks 0-6) using a novel remote monitoring system. Researchers will compare medication adherence between participants using IV and subcutaneous vedolizumab maintenance therapy to see if adherence is lower with self-administration. Participants will be asked to register adherence to medication using the novel remote monitoring system each time they take a dose of vedolizumab and to respond to two questions about bowel symptoms weekly for the first 6 weeks after starting vedolizumab then monthly thereafter for 6 months. Additionally, participants will be asked to enter information regarding demographics and social determinants of health at baseline and other variables listed below at baseline and at weeks 2, …
This description comes directly from the study's public registry record.
Liyah Courageux, MS · 4103329356 · lcourage@mdmercy.com
Makena Trout, BS · 4103329356 · mtrout@mdmercy.com
Always discuss trial participation with your own doctor first.
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| New York University | New York, New York, United States | Recruiting |
| University of North Carolina | Chapel Hill, North Carolina, United States | Recruiting |
| University of Cincinnati | Cincinnati, Ohio, United States | Not Yet Recruiting |
| Vanderbilt University | Nashville, Tennessee, United States | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06750731