Telemedicine in Outpatient Covid-19 Patients (COVID-SMART)

Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid-19; Cardiovascular Risk Factor
• Intervention / Treatment: Device: Withings ScanWatch

• Study Type: Interventional
• Enrollment (Actual): 607
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • BY
    • Munich, BY, Germany, 81377
      • LMU Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemedicine Care; 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; The smart watch is capable of recording SpO2, ECG, and heart rate.
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK); Gesundheitsreferat (GSR), Landeshauptstadt München
• Investigators: Study Director: Steffen Massberg, MD, Department head

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2020
• Primary Completion (Actual): June 27, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Covid-19; cardiovascular disease; telemedicine; SARS-CoV2; ECG; SpO2
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20-448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No