Abstract

TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD): Design and implementation of randomized clinical trial

Cross RK1, Jambaulikar G2, Langenberg P3, Tracy JK3, Collins JF4, Katz J5, Regueiro M6, Schwartz DA7, Quinn CC3. Contemp Clin Trials. 2015 Mar 24. pii: S1551-7144(15)00061-0. doi: 10.1016/j.cct.2015.03.006. [Epub ahead of print]
 
     
Author information

1University of Maryland, Baltimore, Department of Medicine, Division of Gastroenterology and Hepatology, Baltimore, MD, United States. Electronic address: rcross@medicine.umaryland.edu. 2University of Maryland, Baltimore, Department of Medicine, Division of Gastroenterology and Hepatology, Baltimore, MD, United States. 3University of Maryland, Baltimore, Department of Epidemiology and Public Health, Baltimore, MD, United States. 4University of Maryland, Baltimore, Department of Epidemiology and Public Health, Baltimore, MD, United States; Veterans Affairs Cooperative Studies Program, Perry Point, MD, United States. 5MedAdherence LLC, Norwalk, CT, United States. 6University of Pittsburgh, Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Pittsburgh, PA, United States. 7Vanderbilt University, Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Nashville, TN, United States.

Abstract

BACKGROUND: Inflammatory bowel diseases (IBDs), comprised of ulcerative colitis and Crohn's disease, are chronic disorders characterized by worsening of symptoms followed by symptom-free periods. Symptoms have a profound negative impact on quality of life and are associated with increased health care utilization. Despite effective treatments, outcomes are suboptimal secondary to nonadherence, medication intolerance, inconsistent monitoring, poor patient knowledge and limited access to care.

OBJECTIVES: Compare disease activity and quality of life over 1year in a randomized trial of IBD patients receiving standard care versus telemedicine.

METHODS: Patients evaluated at 3 IBD referral centers with worsening symptoms within the last 2years are eligible for randomization to one of two interventions or standard care. The interventions consist of either every other week or weekly assessment of symptoms, side effects, weight and delivery of medication prompts and education via texts to the participant's mobile phone. Individualized alerts and action plans are created on a secure portal. Participants in the standard care group undergo routine and urgent follow-up visits and telephone calls. The primary outcomes group comparisons of changes in disease activity and quality of life scores from baseline to 6 and 12months.

CONCLUSIONS: Methods such as telemedicine are needed to improve monitoring, adherence, self-efficacy, and patient knowledge in IBD. If effective, telemedicine should decrease symptoms, improve quality of life, and decrease health care utilization. The burden associated with use of telemedicine for patients and providers needs to be assessed. The trial is ongoing and will be completed in July 2016.

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