Status:
ACTIVE_NOT_RECRUITING
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Vanderbilt University Medical Center
Conditions:
Inflammatory Bowel Diseases
Crohn Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 h...
Detailed Description
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 h...
Eligibility Criteria
Inclusion
- 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
- 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)
- Imminent surgery (within the next 60 days)
- 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)
Key Trial Info
Start Date :
September 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT05316584
Start Date
September 6 2022
End Date
December 31 2025
Last Update
December 23 2025
Active Locations (5)
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1
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
2
New York University
New York, New York, United States, 10016
3
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7080
4
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267