Telemedical management of symptomatic COVID-19 outpatients.


Journal

ERJ open research
ISSN: 2312-0541
Titre abrégé: ERJ Open Res
Pays: England
ID NLM: 101671641

Informations de publication

Date de publication:
Jul 2024
Historique:
received: 23 03 2024
accepted: 16 04 2024
medline: 13 8 2024
pubmed: 13 8 2024
entrez: 13 8 2024
Statut: epublish

Résumé

COVID-19 remains a challenge to individual health and healthcare resources worldwide. Telemedical surveillance might minimise hospitalisation and direct patient-physician contacts. Yet, randomised clinical trials evaluating telemedical management of COVID-19 patients are lacking. COVID-SMART is a randomised, open-label, controlled clinical trial investigating whether telemedicine reduces the primary end-point of hospitalisation or any unscheduled utilisation of an emergency medical service within 30 days of follow-up. Key secondary end-points included mortality and primary end-point components. We enrolled acutely infected SARS-CoV-2 patients suitable for outpatient care. All presented with ≥1 risk factor for an adverse COVID-19 course. Patients were randomised 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 counselling Of 607 enrolled patients (mean±sd age 46.7±13.5 years), 304 were randomised into the intervention and 303 into the control group. The primary end-point occurred in 6.9% (n=21) of the intervention and in 9.6% (n=29) of the control group (hazard ratio (HR) 0.72, 95% confidence interval (CI) 0.41-1.26; p=0.24). No deaths occurred during follow-up. Fewer intervention group participants utilised outpatient-based emergency medical services (HR 0.43, 95% CI 0.20-0.90; p=0.03). COVID-SMART is the first randomised clinical trial assessing the benefit of telemedicine in an acute respiratory infectious disease. Whereas telemedical management did not reduce the primary end-point of hospitalisation, fewer intervention group patients used outpatient-based emergency services, suggesting a potential benefit for less-acutely infected individuals.

Sections du résumé

Background UNASSIGNED
COVID-19 remains a challenge to individual health and healthcare resources worldwide. Telemedical surveillance might minimise hospitalisation and direct patient-physician contacts. Yet, randomised clinical trials evaluating telemedical management of COVID-19 patients are lacking.
Methods UNASSIGNED
COVID-SMART is a randomised, open-label, controlled clinical trial investigating whether telemedicine reduces the primary end-point of hospitalisation or any unscheduled utilisation of an emergency medical service within 30 days of follow-up. Key secondary end-points included mortality and primary end-point components. We enrolled acutely infected SARS-CoV-2 patients suitable for outpatient care. All presented with ≥1 risk factor for an adverse COVID-19 course. Patients were randomised 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 counselling
Results UNASSIGNED
Of 607 enrolled patients (mean±sd age 46.7±13.5 years), 304 were randomised into the intervention and 303 into the control group. The primary end-point occurred in 6.9% (n=21) of the intervention and in 9.6% (n=29) of the control group (hazard ratio (HR) 0.72, 95% confidence interval (CI) 0.41-1.26; p=0.24). No deaths occurred during follow-up. Fewer intervention group participants utilised outpatient-based emergency medical services (HR 0.43, 95% CI 0.20-0.90; p=0.03).
Conclusions UNASSIGNED
COVID-SMART is the first randomised clinical trial assessing the benefit of telemedicine in an acute respiratory infectious disease. Whereas telemedical management did not reduce the primary end-point of hospitalisation, fewer intervention group patients used outpatient-based emergency services, suggesting a potential benefit for less-acutely infected individuals.

Identifiants

pubmed: 39135664
doi: 10.1183/23120541.00277-2024
pii: 00277-2024
pmc: PMC11317893
pii:
doi:

Types de publication

Journal Article

Langues

eng

Informations de copyright

Copyright ©The authors 2024.

Déclaration de conflit d'intérêts

Conflict of interest: A.S. von Falkenhausen declares to be granted support from the German Research Foundation. Conflict of interest: C. Scherer reports speaker honoraria from AstraZeneca outside the submitted work. Conflict of interest: P. de Villèle reports being an employee of Withings, the manufacturer of Scanwatch, the smart watch that was used in this trial. Conflict of interest: M.F. Sinner declares being granted support from the German Centre for Cardiovascular Research and with travel support from Biotronik. Conflict of interest: All other authors declare no potential conflict of interest.

Auteurs

Aenne S von Falkenhausen (AS)

Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.
German Centre for Cardiovascular Research (DZHK), partner site: Munich Heart Alliance, Munich, Germany.

Scott Geipel (S)

Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.

Antonia Gail (A)

Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.

Clemens Scherer (C)

Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.
German Centre for Cardiovascular Research (DZHK), partner site: Munich Heart Alliance, Munich, Germany.

Sven Stockhausen (S)

Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.
German Centre for Cardiovascular Research (DZHK), partner site: Munich Heart Alliance, Munich, Germany.

Lauren E Sams (LE)

Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.
German Centre for Cardiovascular Research (DZHK), partner site: Munich Heart Alliance, Munich, Germany.

Finn Becker (F)

Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.
German Centre for Cardiovascular Research (DZHK), partner site: Munich Heart Alliance, Munich, Germany.

Philipp M Doldi (PM)

Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.
German Centre for Cardiovascular Research (DZHK), partner site: Munich Heart Alliance, Munich, Germany.

Eric Lemmermöhle (E)

Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.

Paul de Villèle (P)

Withings, Issy-les-Moulineaux, France.

Michael Schleef (M)

MVZ Sonnen-Gesundheitszentrum, Munich, Germany.

Marc Becker (M)

Labor Becker, Munich, Germany.

Moritz Lauterbach (M)

SaniPlus Apotheken, Munich, Germany.

Steffen Massberg (S)

Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.
German Centre for Cardiovascular Research (DZHK), partner site: Munich Heart Alliance, Munich, Germany.

Stefan Kääb (S)

Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.
German Centre for Cardiovascular Research (DZHK), partner site: Munich Heart Alliance, Munich, Germany.
These authors share senior authorship.

Moritz F Sinner (MF)

Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.
German Centre for Cardiovascular Research (DZHK), partner site: Munich Heart Alliance, Munich, Germany.
These authors share senior authorship.

Classifications MeSH