Telemedicine in Outpatient Covid-19 Patients

Covid-19 Clinical Trial

— COVID-SMART  

Official title:

Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04471636
• Other study ID #: 20-448
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2022
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 607
• Est. completion date: June 30, 2023
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Covid-19

Intervention

Device:
• Withings ScanWatch
The smart watch is capable of recording SpO2, ECG, and heart rate.

Locations

Country	Name	City	State
Germany	LMU Klinikum	Munich	BY

Sponsors (3)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of participants hospitalized	Occurrence of hospitalization during follow-up	30 days
Secondary	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
Secondary	Rate of participants experiencing death of any cause	Occurrence of death of any cause during follow-up	30 days
Secondary	Rate of participants experiencing death of Covid-19	Occurence of daeth of Covid-19 during follow-up	30 days