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| Name | Class |
|---|---|
| Gesundheitsreferat (GSR), Landeshauptstadt München | UNKNOWN |
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine Care | Experimental | 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. |
|
| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Withings ScanWatch | Device | The smart watch is capable of recording SpO2, ECG, and heart rate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of participants hospitalized | Occurrence of hospitalization during follow-up | 30 days |
| Rate of participants with unplanned use of hospital emergency department or emergency medical service |
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Inclusion Criteria:
Confirmed SARS-CoV2 infection and clinical Covid-19 disease
age ≥18 years
Presence of ≥1 relevan cardiovascular condition, defined as (or):
availability of smartphone and sufficient internet connectivity at home
ability to use smartwatch
informed consent to study participation and data protection concept
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steffen Massberg, MD | Department Head | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMU Klinikum | Munich | Bavaria | 81377 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40259893 | Derived | von Falkenhausen AS, Gail A, Geipel S, Scherer C, Stockhausen S, Sams LE, Becker F, Massberg S, Kaab S, Sinner MF. Symptoms of Depression and Anxiety After COVID-19 Despite Systematic Telemedical Care: Results From the Prospective COVID-SMART Study. Depress Anxiety. 2025 Apr 13;2025:9989990. doi: 10.1155/da/9989990. eCollection 2025. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Occurrence of any of the above during follow-up
| 30 days |
| Rate of participants experiencing death of any cause | Occurrence of death of any cause during follow-up | 30 days |
| Rate of participants experiencing death of Covid-19 | Occurence of daeth of Covid-19 during follow-up | 30 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |