Data_Sheet_1_TELERA—Asynchronous TELEmedicine for Patients With Rheumatoid Arthritis: Study Protocol for a Prospective, Multi-Center, Randomized Controlled Trial.docx

Innovative strategies are needed to adequately assess and monitor disease activity of patients with rheumatoid arthritis (RA) in times of scarce appointments. The aim of the TELERA study is to evaluate the feasibility and performance of asynchronous telemedicine visits based on patient-generated data and patient's drug history. RA patients use a medical app, ABATON, that captures the results of a self-performed quick CRP-test, joint-count, and electronic patient-reported outcomes in between visits. This is a prospective, multi-center, randomized controlled trial performed in four German university centers. The estimated sample size is 120 patients. The main outcome is the agreement of rheumatologists' treatment decisions based on asynchronous telemedicine patient-generated data with traditional in-person rheumatology clinic-based decisions and with patient suggestions. The TELERA trial will provide evidence regarding the implementation of remote care in rheumatology.
Clinical Trial Registration: This clinical trial was registered at German Registry for Clinical Trials (DRKS). http://www.drks.de/DRKS00016350, identifier: DRKS00024928.

在门诊预约紧张的背景下，亟需创新策略以充分评估与监测类风湿关节炎（Rheumatoid Arthritis, RA）患者的疾病活动度。TELERA研究旨在评估基于患者自主上报数据与用药史的异步远程门诊的可行性与应用效果。类风湿关节炎患者可使用名为ABATON的医疗应用程序，在两次门诊之间完成快速C反应蛋白（C-reactive protein, CRP）自测、关节计数以及电子患者报告结局的录入，该程序将自动采集上述数据。本研究为一项前瞻性多中心随机对照试验，在德国4所大学医学中心开展，计划纳入120例患者。本研究的主要结局为：基于异步远程门诊患者自主上报数据的风湿科医师治疗决策，与传统线下风湿科门诊决策及患者自身诉求的一致性。TELERA试验将为风湿科远程医疗的临床落地提供循证依据。临床试验注册：本临床试验已在德国临床试验注册库（German Registry for Clinical Trials, DRKS）完成注册，注册网址为http://www.drks.de/DRKS00016350，注册编号为DRKS00024928。