Telemedicine in Outpatient Covid-19 Patients

Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients

Sponsors

Lead Sponsor: Ludwig-Maximilians - University of Munich

Collaborator: Gesundheitsreferat (GSR), Landeshauptstadt München
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Source Ludwig-Maximilians - University of Munich
Brief 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.

Overall Status Recruiting
Start Date 2020-09-18
Completion Date 2021-12-01
Primary Completion Date 2021-11-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service 30 days
Secondary Outcome
Measure Time Frame
Rate of participants hospitalized 30 days
Rate of participants with unplanned use of hospital emergency department or emergency medical service 30 days
Rate of participants experiencing death of any cause 30 days
Rate of participants experiencing death of Covid-19 30 days
Enrollment 600
Condition
Intervention

Intervention Type: Device

Intervention Name: Withings ScanWatch

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

Arm Group Label: Telemedicine Care

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Steffen Massberg, MD Study Director Department Head
Overall Contact

Last Name: Moritz F Sinner, MD, MPH

Phone: +49-89-4400-76159

Email: [email protected]

Location
Facility: Status: Contact: LMU Klinikum Moritz F Sinner, MD, MPH
Location Countries

Germany

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Ludwig-Maximilians - University of Munich

Investigator Full Name: Moritz F. Sinner

Investigator Title: Assistant Professor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Telemedicine Care

Type: Experimental

Description: 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.

Label: Control

Type: No Intervention

Description: 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.

Acronym COVID-SMART
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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