Telemedicine in Outpatient Covid-19 Patients
Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients
| Sponsors |
Lead Sponsor: Ludwig-Maximilians - University of Munich Collaborator:
Gesundheitsreferat (GSR), Landeshauptstadt München
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| Source | Ludwig-Maximilians - University of Munich |
| 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. |
| Overall Status | Recruiting | ||||||||||
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| Start Date | 2020-09-18 | ||||||||||
| Completion Date | 2021-12-01 | ||||||||||
| Primary Completion Date | 2021-11-01 | ||||||||||
| Phase | N/A | ||||||||||
| Study Type | Interventional | ||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 600 |
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| Intervention |
Intervention Type: Device Intervention Name: Withings ScanWatch Description: The smart watch is capable of recording SpO2, ECG, and heart rate. Arm Group Label: Telemedicine Care |
| 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) - 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 Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
| Overall Official |
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| Overall Contact |
Last Name: Moritz F Sinner, MD, MPH Phone: +49-89-4400-76159 Email: [email protected] |
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| Location |
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| Location Countries |
Germany |
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| Verification Date |
2021-04-01 |
| Responsible Party |
Type: Principal Investigator Investigator Affiliation: Ludwig-Maximilians - University of Munich Investigator Full Name: Moritz F. Sinner Investigator Title: Assistant Professor |
| Keywords | |
| Has Expanded Access | No |
| Number Of Arms | 2 |
| Arm Group |
Label: Telemedicine Care Type: Experimental Description: 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. Label: Control Type: No Intervention Description: 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. |
| Acronym | COVID-SMART |
| Patient Data | No |
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: None (Open Label) |
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