Telemedicine in Outpatient Covid-19 Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid-19, Cardiovascular Risk Factor

Intervention / Treatment
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* Device: Withings ScanWatch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine Care<br>Patients receive assessment at baseline and at 30 day follow up. Patient receive a smart watch capeable of recording SpO2, ECG, and heart rate. Patients also receive access to 24/7 medical hotline for telemedical care. All public services of the health care system remain available. | Device: Withings ScanWatch<br>* The smart watch is capable of recording SpO2, ECG, and heart rate.<br>|
| No Intervention: Control<br>Patients receive assessment at baseline and at 30 day follow up. Patient have access to all services of the health care system, but do not receive a smart watch or medical hotline access. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service | Occurrence of any of the above during follow-up | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants hospitalized | Occurrence of hospitalization during follow-up | 30 days | 
| Rate of participants with unplanned use of hospital emergency department or emergency medical service | Occurrence of any of the above during follow-up | 30 days | 
| Rate of participants experiencing death of any cause | Occurrence of death of any cause during follow-up | 30 days | 
| Rate of participants experiencing death of Covid-19 | Occurence of daeth of Covid-19 during follow-up | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG, SARS-CoV2, Covid-19, cardiovascular disease, telemedicine, SpO2