Introduction: Inflammatory bowel disease (IBD) is a chronic condition that results in debilitating symptoms. Although effective treatments exist, inadequate monitoring of symptoms and side effects, nonadherence, and poor patient knowledge are barriers to success. Telemedicine has been used in other chronic diseases to improve outcomes;pilot testing of telemedicine demonstrated that it is feasible and accepted in IBD. Our preliminary results from a randomized trial in participants with ulcerative colitis showed significant improvements in quality of life from baseline to one year in the telemanagement group. Study Design: Telemedicine for Patients with Inflammatory Bowel Disease (Tele-IBD) is a 12-month, multicenter, randomized, controlled trial to assess the impact of Tele-IBD compared to standard care in participants with IBD.
The aims of the study are to: (1) assess disease activity in participants with IBD using Tele-IBD compared to participants using standard care, (2) assess quality of life in participants with IBD using Tele-IBD compared to participants using standard care, and (3) estimate differences of person-level rates of utilization of health care resources in participants with IBD using Tele-IBD compared to participants using standard care. Methods: Tele-IBD consists of a web-portal and a weight scale. Participants answer questions about IBD symptoms, side effects and adherence using their home PC or a laptop with wireless Internet access provided to them for the study. A series of educational topics is administered via video messaging every 2-3 weeks. Tele-IBD participants complete self-testing weekly or every other week;the results are immediately available on the web-portal for review. Based on the responses, alerts and action plans are created for each participant. A nurse care coordinator consults the participant's medical provider for management changes if necessary. IBD patients evaluated at the University of Maryland, Baltimore, University of Pittsburgh, and Vanderbilt University will be invited to participate. Interested patients will be randomized in a 1:1:1 fashion to receive Tele- IBD weekly, Tele-IBD every other week, or standard care. Disease activity, quality of life, medical adherence, and utilization of health care resources will be assessed every 6 months for one year. In addition, provider interactions with patients in all three arms will be monitored and recorded. Expected Findings: Tele-IBD will decrease disease activity and improve quality of life through improved adherence and monitoring of symptoms, earlier and more effective implementation of therapy, more frequent patient-provider interactions, and improved patient self-management. Better control of IBD will result in decreased utilization of health care resources. Significance: If Tele-IBD improves outcomes, it is likely to be used to improve IBD care, to contain health care costs, to increase access to care, and to improve adherence with physician performance measures.

Public Health Relevance

Improved methods are needed to monitor patients with inflammatory bowel disease. Telemedicine has shown promise in patients with other chronic diseases;pilot testing in our patients with inflammatory bowel disease demonstrated that the technology was feasible and improved clinical outcomes. The telemedicine system for patients with inflammatory bowel disease (Tele-IBD) should improve outcomes for patients;improve access to care in areas with limited resources, and decrease health care costs.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Project (R01)
Project #
5R01HS018975-02
Application #
8546329
Study Section
Health Care Technology and Decision Science (HTDS)
Program Officer
Chang, Christine Sutine
Project Start
2012-09-30
Project End
2015-07-31
Budget Start
2013-08-01
Budget End
2014-07-31
Support Year
2
Fiscal Year
2013
Total Cost
Indirect Cost
Name
University of Maryland Baltimore
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
188435911
City
Baltimore
State
MD
Country
United States
Zip Code
21201
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McLean, Leon P; Cross, Raymond K; Shea-Donohue, Terez (2013) Combined blockade of IL-17A and IL-17F may prevent the development of experimental colitis. Immunotherapy 5:923-5