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

BACKGROUND: Inflammatory bowel diseases (IBD), 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 1 year 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 2 years 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 12 months.

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.