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A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy

Active Not RecruitingNA

Sponsor: University of Maryland, Baltimore

Conditions: Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

Interventions: Remote monitoring

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 a new oral or subcutaneous treatment for IBD
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

Exclusion Criteria:

1. Inability to speak and read English
2. Inability to comply with the study protocol
3. Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis
4. Patients initiating oral corticosteroids only (without concurrent use of an oral or subcutaneous maintenance therapy)
5. Imminent surgery (within the next 60 days)
6. History of short bowel syndrome
7. 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)

Locations (5)

Baltimore, Maryland, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Nashville, Tennessee, United States