Official Title
Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients
Brief Summary

Covid-19, a commonly severe respiratory tract infection caused by the SARS-CoV2Coronavirus, poses an increasing threat to individual health and health care systems. Theindividual disease course ranges from mild to life threatening, the pandemic spread leadsto a shortage of health care resources including intensive care availability. It shouldbe the overarching goal to allocate sparse health care resources to those most at needand to simultaneously avoid unnecessary blocking of resources by clinically unjustifiedhospitalizations.Individuals with preexisting cardiovascular conditions are at the highest risk of healthdeterioration, even at younger age. Objective criteria for hospitalization are notimmediately available in a outpatient settings. Hence, hospitalization and emergencymedical contact is often triggered by subjectively interpreted symptoms. The goal of thisproject is thus to improve the availability of objective measurements in the outpatientsetting by means of an innovative, smartwatch mediated telemedicine approach.To achieve this goal, the investigators will conduct a randomized clinical trialcomparing a smartwatch based telemedicine intervention with standard of care. Theintervention group will receive regular objective measurements of heart rate, ECG, andSpO2 and will get access to a 24/7 medical care hotline for consultation. Theinvestigators hypothesize that the intervention group will benefit by a significantreduction in unnecessary hospitalizations and unplanned emergency medicine contacts.

Unknown status
COVID-19
Cardiovascular Risk Factor

Device: Withings ScanWatch

The smart watch is capable of recording SpO2, ECG, and heart rate.

Eligibility Criteria

Inclusion Criteria:

- Confirmed SARS-CoV2 infection and clinical Covid-19 disease

- age ≥18 years

- Presence of ≥1 relevan cardiovascular condition, defined as (or):

- atrial fibrillation

- systolic or diastolic heart failure

- LV ejection fraction <50%

- coronary artery disease with past PCI or CABG

- Past myocardial infarction

- diabetes mellitus

- arterial hypertension (treated or untreated)

- active smoking

- chronic obstructive lung disease

- obesity (BMI ≥30kg/m2)

- availability of smartphone and sufficient internet connectivity at home

- ability to use smartwatch

- informed consent to study participation and data protection concept

Exclusion Criteria:

- Participation in concurrent clinical trial

- indication for hospitalization at study entry

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Locations

LMU Klinikum
Munich, BY, Germany

Steffen Massberg, MD, Study Director
Department Head

Ludwig-Maximilians - University of Munich
NCT Number
Keywords
SARS-CoV2
Covid-19
Cardiovascular disease
telemedicine
ECG
SpO2
MeSH Terms
COVID-19