A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence Wi… (NCT05316584) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
United States123 participantsStarted 2022-09-06
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Inability to speak and read English
✕. Inability to comply with the study protocol
✕. Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis
✕. Patients initiating oral corticosteroids only (without concurrent use of an oral or subcutaneous maintenance therapy)