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COVID-SMART: Telemedicine in Outpatient Covid-19 Patients

Sponsor
Ludwig-Maximilians - University of Munich (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04471636
Collaborator
Gesundheitsreferat (GSR), Landeshauptstadt München (Other), Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) (Other)
607
Enrollment
1
Location
2
Arms
33.3
Anticipated Duration (Months)
18.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Withings ScanWatch
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
607 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients
Actual Study Start Date :
Sep 18, 2020
Actual Primary Completion Date :
Jun 27, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service [30 days]

    Occurrence of any of the above during follow-up

Secondary Outcome Measures

  1. Rate of participants hospitalized [30 days]

    Occurrence of hospitalization during follow-up

  2. Rate of participants with unplanned use of hospital emergency department or emergency medical service [30 days]

    Occurrence of any of the above during follow-up

  3. Rate of participants experiencing death of any cause [30 days]

    Occurrence of death of any cause during follow-up

  4. Rate of participants experiencing death of Covid-19 [30 days]

    Occurence of daeth of Covid-19 during follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 LMU Klinikum Munich BY Germany 81377

Sponsors and Collaborators

  • Ludwig-Maximilians - University of Munich
  • Gesundheitsreferat (GSR), Landeshauptstadt München
  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Investigators

  • Study Director: Steffen Massberg, MD, Department Head

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Moritz F. Sinner, Assistant Professor, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT04471636
Other Study ID Numbers:
  • 20-448
First Posted:
Jul 15, 2020
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Moritz F. Sinner, Assistant Professor, Ludwig-Maximilians - University of Munich
SARS-CoV2
Covid-19
cardiovascular disease
telemedicine
ECG
SpO2
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jun 28, 2022