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
{"title":"Telemedical management of symptomatic Covid-19 outpatients","authors":"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","doi":"10.1183/23120541.00277-2024","DOIUrl":null,"url":null,"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)","PeriodicalId":504874,"journal":{"name":"ERJ Open Research","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"ERJ Open Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1183/23120541.00277-2024","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
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)