A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial (Preprint)

Abstract

Background: Telemedicine has been successfully used to provide inflammatory bowel disease (IBD) patients with healthcare services remotely via the implementation of information and communications technology, which uses safe and feasible applications that have been well accepted by patients in remission. However, the design of telemedicine applications in this setting involve difficulties that hinder the adherence of patients to the follow-up plans and the efficacy of these systems to improve disease activity and quality of life Methods:We describe the development of a remote monitoring system and the difficulties encountered in designing the platform. A 3-arm randomized controlled trial was designed to evaluate the effectiveness of this web platform in disease management compared with G_NT and G_Control.Results: According to the schedules established for the medical treatment initiated (corticosteroids, immunosuppressants or biological agents), patients from each group answered periodic questionnaires regarding disease activity, quality of life, therapeutic adherence, adverse effects, satisfaction, work productivity, and social activities. Blood and stool analyses (fecal calprotectin) were performed periodically. Based on the results of these tests in G_TECCU, alerts were generated in a web platform with adapted action plans, including changes in medication and frequency of follow-up. The main issues found were the development of an easy to use web platform, the selection of validated clinical scores and objective biomarkers for remote monitoring and the design of a clinical trial to compare the three main follow-up methods evaluated to date in IBD. Conclusions:The development of a web-based remote management program for safe and adequate control of IBD proved challenging. The results of this clinical trial will advance knowledge regarding the effectiveness of TECCU web for improvement of disease activity, quality of life, and use of health care resources in complex IBD patients.