NCT04471636

Telemedicine in Outpatient Covid-19 Patients

Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Covid-19, a commonly severe respiratory tract infection caused by the SARS-CoV2 Coronavirus, poses an increasing threat to individual health and health care systems. The individual disease course ranges from mild to life threatening, the pandemic spread leads to a shortage of health care resources including intensive care availability. It should be the overarching goal to allocate sparse health care resources to those most at need and to simultaneously avoid unnecessary blocking of resources by clinically unjustified hospitalizations. Individuals with preexisting cardiovascular conditions are at the highest risk of health deterioration, even at younger age. Objective criteria for hospitalization are not immediately available in a outpatient settings. Hence, hospitalization and emergency medical contact is often triggered by subjectively interpreted symptoms. The goal of this project is thus to improve the availability of objective measurements in the outpatient setting by means of an innovative, smartwatch mediated telemedicine approach. To achieve this goal, the investigators will conduct a randomized clinical trial comparing a smartwatch based telemedicine intervention with standard of care. The intervention group will receive regular objective measurements of heart rate, ECG, and SpO2 and will get access to a 24/7 medical care hotline for consultation. The investigators hypothesize that the intervention group will benefit by a significant reduction in unnecessary hospitalizations and unplanned emergency medicine contacts.

Conditions

• Covid-19
• Cardiovascular Risk Factor

Interventions

Type	Name	Description
DEVICE	Withings ScanWatch	The smart watch is capable of recording SpO2, ECG, and heart rate.

Timeline

• Start date: 2020-09-18
• Primary completion: 2022-06-27
• Completion: 2023-06-30
• First posted: 2020-07-15
• Last updated: 2022-06-28

Locations

1 site across 1 country: Germany