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

June 27, 2022 updated by: Moritz F. Sinner, Ludwig-Maximilians - University of Munich

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

607

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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
Time Frame: 30 days
Occurrence of any of the above during follow-up
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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