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

Primary Purpose

Covid-19, Cardiovascular Risk Factor

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Withings ScanWatch
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring SARS-CoV2, Covid-19, cardiovascular disease, telemedicine, ECG, SpO2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LMU Klinikum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemedicine Care

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of participants hospitalized
Occurrence of hospitalization during follow-up
Rate of participants with unplanned use of hospital emergency department or emergency medical service
Occurrence of any of the above during follow-up
Rate of participants experiencing death of any cause
Occurrence of death of any cause during follow-up
Rate of participants experiencing death of Covid-19
Occurence of daeth of Covid-19 during follow-up

Full Information

First Posted
July 9, 2020
Last Updated
June 27, 2022
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Gesundheitsreferat (GSR), Landeshauptstadt München, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
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1. Study Identification

Unique Protocol Identification Number
NCT04471636
Brief Title
Telemedicine in Outpatient Covid-19 Patients
Acronym
COVID-SMART
Official Title
Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
June 27, 2022 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Gesundheitsreferat (GSR), Landeshauptstadt München, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, Cardiovascular Risk Factor
Keywords
SARS-CoV2, Covid-19, cardiovascular disease, telemedicine, ECG, SpO2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
607 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine Care
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Withings ScanWatch
Intervention Description
The smart watch is capable of recording SpO2, ECG, and heart rate.
Primary Outcome Measure Information:
Title
Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service
Description
Occurrence of any of the above during follow-up
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate of participants hospitalized
Description
Occurrence of hospitalization during follow-up
Time Frame
30 days
Title
Rate of participants with unplanned use of hospital emergency department or emergency medical service
Description
Occurrence of any of the above during follow-up
Time Frame
30 days
Title
Rate of participants experiencing death of any cause
Description
Occurrence of death of any cause during follow-up
Time Frame
30 days
Title
Rate of participants experiencing death of Covid-19
Description
Occurence of daeth of Covid-19 during follow-up
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Massberg, MD
Organizational Affiliation
Department Head
Official's Role
Study Director
Facility Information:
Facility Name
LMU Klinikum
City
Munich
State/Province
BY
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Telemedicine in Outpatient Covid-19 Patients

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