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Randomized, controlled trial of home telemanagement in patients with ulcerative colitis (UC HAT)*

Cross, Raymond K. MD, MS1,2; Cheevers, Nadia RN, BSN2; Rustgi, Ankur MPH2; Langenberg, Patricia PhD3; Finkelstein, Joseph MD, PhD4

doi: 10.1002/ibd.21795
Original Article: Original Clinical Articles

Background:: Outcomes are suboptimal in ulcerative colitis (UC). Telemedicine for UC is feasible and improves outcomes. Our goals were to evaluate a home telemanagement system for UC (UC HAT) on disease activity, quality of life (QoL), and adherence compared to best available care (BAC) in a randomized, controlled trial.

Methods:: Adults with UC were randomly assigned to receive UC HAT or BAC for 12 months. UC HAT recruits answered questions regarding disease activity, adherence, side effects, and measured their weight weekly. An educational curriculum was delivered after each session. Alerts and action plans were generated based on the results. BAC underwent routine follow‐up, received written action plans, and were given educational fact sheets. Seo Index scores, Inflammatory Bowel Disease Questionnaire (IBDQ) scores, and adherence rates were compared between UC HAT and BAC at 1 year.

Results:: Twenty‐five patients were randomized to UC HAT and 22 to BAC. After 12 months, 11 withdrew in UC HAT compared to 5 in BAC. Disease activity, QoL, and adherence were not different between groups at any timepoint postbaseline. Adjusted analyses of trial completers using all available data demonstrated decreased Seo Index (11.9 in UC HAT (P = 0.08) versus 1.2 in BAC (P = 0.84) and increased IBDQ scores (12.5 in UC HAT (P = 0.04) versus to −3.8 in BAC (P = 0.47) from baseline in UC HAT compared to BAC.

Conclusions:: UC HAT did not improve disease activity, QoL, or adherence compared to BAC after 1 year. After adjustment for baseline disease knowledge, UC HAT trial completers experienced significant gains in disease‐specific QoL from baseline compared to BAC trial completers. Our results suggest a potential benefit of UC HAT. Further research is indicated to determine if telemedicine improves outcomes in patients with IBD. (Inflamm Bowel Dis 2012;)

1Veterans Affairs, Maryland Heath Care System, Baltimore, Maryland, University of Maryland School of Medicine, Baltimore, Maryland

2Department of Medicine, Division of Gastroenterology Hepatology, University of Maryland School of Medicine, Baltimore, Maryland

3Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland

4Chronic Disease Informatics Program, Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University, Baltimore, Maryland

100 North Greene St., Lower Level, Baltimore, MD 21201

Email: rcross@medicine.umaryland.edu

Received 2 May 2011; Accepted 16 May 2011

Published online 17 June 2011.

Sponsored by the Broad Medical Research Program (BRMP‐0190), University of Maryland General Clinical Research Center Grant (M01 RR 16500), General Clinical Research Centers Program, National Center for Research Resources (NCRR), NIH, and the Baltimore Education and Research Foundation.

© Crohn's & Colitis Foundation of America, Inc.
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