Abstract
Background: Inflammatory bowel diseases (IBD), associated with a significant burden on patients' lives, are becoming increasingly common. Patients with IBD need continuous treatment and lifelong monitoring, which could be achieved by telemonitoring. Telemonitoring has been shown to be effective in improving outcomes for patients with IBD, and can provide a more convenient and accessible way for patients to receive care. However, the certainty of evidence remains low. This article outlines the methodology of a randomized control study that aims to assess the efficacy of telemonitoring compared to face-to-face follow-up for patients with IBD in Russia, hypothesizing that the implementation of telemonitoring will lead to improvement in clinical, social, and organizational areas. Methods: The TIGE-Rus study is a randomized controlled trial. The study consists of three stages, including selection of patients and random assignment into two groups with a ratio of 1:1, follow-up care using telemonitoring or face-to-face appointments, and evaluation and comparison of follow-up efficacy in both groups. In the first stage, all patients will undergo laboratory tests and instrumental examinations, and fill out questionnaires to measure disease activity, quality of life, medication adherence, psychological well-being, and satisfaction with medical care. In the second stage, the control group will receive standard care while the telemonitoring group will have access to a web platform where they can report their clinical activity, fill out questionnaires, and have online consultations with gastroenterologists. The gastroenterologists will also make monthly phone calls to each patient in the telemonitoring group to monitor their progress. In the third stage of the study, both the telemonitoring group and the control group will be re-hospitalized after six months of monitoring. IBD activity will be evaluated through laboratory and instrumental examinations. Additionally, all the participants will complete questionnaires to assess the disease activity, medication adherence, quality of life, psychological well-being, and satisfaction with medical care in both groups. Conclusions: The trial will explore whether telemonitoring is effective in improving clinical, social, and organizational aspects in the management of patients with IBD in the setting of the Russian healthcare system.