Cardiovascular Risk Factor, Covid-19
Conditions
Keywords
SARS-CoV2, Covid-19, cardiovascular disease, telemedicine, ECG, SpO2
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.
Interventions
DEVICEWithings ScanWatch
The smart watch is capable of recording SpO2, ECG, and heart rate.
Sponsors
Gesundheitsreferat (GSR), Landeshauptstadt München
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of participants hospitalized | 30 days | Occurrence of hospitalization during follow-up |
| 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 |
| Rate of participants experiencing death of any cause | 30 days | Occurrence of death of any cause during follow-up |
| Rate of participants experiencing death of Covid-19 | 30 days | Occurence of daeth of Covid-19 during follow-up |
Countries
Germany
Outcome results
None listed