Akhmedzyanova Dina A, Shumskaya Yuliya F, Vasilev Yuriy A, Vladzymyrskyy Anton V, Omelyanskaya Olga V, Alymova Yulya A, Mnatsakanyan Marina G, Panferov Alexandr S, Taschyan Olga V, Kuprina Irina V, Yurazh Marta V, Eloev Artur S, Reshetnikov Roman V
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department, Moscow 127051, Russia.
Gastroenterology Department, The First Sechenov Moscow State Medical University (Sechenov University), Moscow 119991, Russia.
J Clin Med. 2024 Dec 18;13(24):7734. doi: 10.3390/jcm13247734.
: 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. 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. : 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.
炎症性肠病（IBD）给患者的生活带来了巨大负担，且日益常见。IBD患者需要持续治疗和终身监测，而远程监测可以实现这一点。事实证明，远程监测对于改善IBD患者的治疗效果是有效的，并且可以为患者提供更便捷的就医途径。然而，证据的确定性仍然较低。本文概述了一项随机对照研究的方法，该研究旨在评估在俄罗斯，与面对面随访相比，远程监测对IBD患者的疗效，假设实施远程监测将在临床、社会和组织领域带来改善。TIGE-Rus研究是一项随机对照试验。该研究包括三个阶段，即选择患者并按1:1的比例随机分为两组，采用远程监测或面对面预约进行随访护理，以及评估和比较两组的随访疗效。在第一阶段，所有患者将接受实验室检查和器械检查，并填写问卷以测量疾病活动度、生活质量、药物依从性、心理健康状况以及对医疗护理的满意度。在第二阶段，对照组将接受标准护理，而远程监测组将可以使用一个网络平台，在该平台上他们可以报告自己的临床活动、填写问卷并与胃肠病学家进行在线咨询。胃肠病学家还将每月给远程监测组的每位患者打电话以监测其进展。在研究的第三阶段，远程监测组和对照组在监测六个月后都将再次住院。将通过实验室检查和器械检查来评估IBD活动度。此外，所有参与者都将完成问卷，以评估两组的疾病活动度、药物依从性、生活质量、心理健康状况以及对医疗护理的满意度。该试验将探索在俄罗斯医疗保健系统的背景下，远程监测在改善IBD患者管理的临床、社会和组织方面是否有效。
