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โ† Trials
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Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention

Recruitingn/aAges 18 Years - anyAllMercy Medical Center
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. At least 18 years of age or older 2. Have documented IBD based on usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology 3. Initiating treatment with vedolizumab 4. Have access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access 5. Ability to understand the protocol and provide informed consent in English or Spanish Exclusion Criteria: 1. Inability to speak and read English or Spanish 2. Unable to comply with the study protocol including inability to access the internet and/or inadequate access to a smart device 3. Unable to access vedolizumab due to insurance restrictions 4. Unable to follow up at respective sites due to insurance restrictions or other barriers (i.e., distance from patient's home to study site) 5. Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis 6. Imminent surgery (within the next 60 days) 7. History of short bowel syndrome 8. Uncontrolled medical or psychiatric disease at the opinion of the investigator 1. Degenerative neurologic condition 2. Unstable angina 3. Symptomatic peripheral vascular disease 4. Malignancy within the last 2 years (excluding squamous or basal cell cancers of the skin) 5. Poorly controlled depression, mania, and schizophrenia 6. Serious active infection requiring antimicrobial therapy (excluding CD patients with perianal CD on antibiotics)
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What it tests

  • Tappt
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Where

6 sites
Tulane University
New Orleans, United States
Capital Digestive Care
Chevy Chase, United States
NYU Langone Health
New York, United States
University of North Carolina
Chapel Hill, United States
University of Cincinnati
Cincinnati, United States
Vanderbilt University
Nashville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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