Telemedical management of symptomatic Covid-19 outpatients

Aenne S von Falkenhausen, Scott Geipel, Antonia Gail, Clemens Scherer, Sven Stockhausen, Lauren E Sams, Finn Becker, Philipp M Doldi, Eric Lemmermöhle, Paul de Villèle, Michael Schleef, Marc Becker, Moritz Lauterbach, Steffen Massberg, Stefan Kääb, Moritz F Sinner
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Abstract

Covid-19 remains a challenge to individual health and health care resources worldwide. Telemedical surveillance might minimize hospitalization and direct patient-physician-contacts. Yet, randomized clinical trials evaluating telemedical management of Covid-19 patients are lacking.COVID SMART is a randomized, open label, controlled clinical trial investigating whether telemedicine reduces the primary endpoint of hospitalization or any unscheduled utilization of an emergency medical service within 30 days of follow-up. Key secondary endpoints included mortality and primary endpoint components. We enrolled acutely infected SARS-CoV2 patients suitable for outpatient care. All presented with ≥1 risk factor for an adverse Covid-19 course. Patients were randomized 1:1 into a control group receiving standard of care and an intervention group receiving smartphone-based assessment of oxygen saturation, heart rate and electrocardiogram, and telemedical counsellingviaa 24/7 emergency hotline.Of 607 enrolled patients (mean age 46.7±13.5 years), 304 were randomized into the intervention and 303 into the control group. The primary endpoint occurred in 6.9% (n=21) of the intervention and in 9.6% (n=29) of the control group (hazard ratio 0.72, 95% confidence interval 0.41–1.26; p=0.24). No deaths occurred during follow-up. Fewer intervention group participants utilized outpatient-based emergency medical services (hazard ratio 0.43, 95% confidence interval 0.20–0.90; p=0.03).COVID SMART is the first randomized clinical trial assessing the benefit of telemedicine in an acute respiratory infectious disease. Whereas telemedical management did not reduce the primary endpoint of hospitalization, fewer intervention group patients used outpatient-based emergency services, suggesting a potential benefit for less-acutely infected individuals.clinicaltrials.gov (NCT04471636)
对有症状的 Covid-19 门诊病人进行远程医疗管理
Covid-19 仍是全球个人健康和医疗资源面临的一项挑战。远程医疗监控可以最大限度地减少住院治疗和患者与医生的直接接触。COVID SMART 是一项随机、开放标签、对照临床试验,旨在研究远程医疗是否能减少主要终点--住院治疗或随访 30 天内任何非计划使用紧急医疗服务的情况。主要次要终点包括死亡率和主要终点组成部分。我们招募了适合门诊治疗的急性感染 SARS-CoV2 患者。所有患者都有≥1个导致Covid-19不良病程的危险因素。患者按 1:1 随机分为对照组和干预组,对照组接受标准护理,干预组接受基于智能手机的血氧饱和度、心率和心电图评估,并通过 24/7 紧急热线接受远程医疗咨询。在 607 名入选患者(平均年龄为 46.7±13.5 岁)中,304 人被随机分配到干预组,303 人被分配到对照组。6.9%的干预组患者(21人)和9.6%的对照组患者(29人)出现了主要终点(危险比为0.72,95%置信区间为0.41-1.26;P=0.24)。随访期间无死亡病例发生。COVID SMART 是首个评估远程医疗对急性呼吸道传染病益处的随机临床试验。虽然远程医疗管理并未降低住院治疗的主要终点,但干预组患者使用门诊急诊服务的人数较少,这表明对急性感染较轻的患者有潜在益处。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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