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Clinical Trials/NCT04471636
NCT04471636
Unknown
N/A

Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients

Ludwig-Maximilians - University of Munich1 site in 1 country607 target enrollmentSeptember 18, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Covid-19
Sponsor
Ludwig-Maximilians - University of Munich
Enrollment
607
Locations
1
Primary Endpoint
Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 18, 2020
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Moritz F. Sinner

Assistant Professor

Ludwig-Maximilians - University of Munich

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)

Exclusion Criteria

  • Participation in concurrent clinical trial
  • indication for hospitalization at study entry

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Rate of participants hospitalized(30 days)
  • Rate of participants experiencing death of any cause(30 days)
  • Rate of participants experiencing death of Covid-19(30 days)
  • Rate of participants with unplanned use of hospital emergency department or emergency medical service(30 days)

Study Sites (1)

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