Telemedicine in Outpatient Covid-19 Patients
- Conditions
- Covid-19Cardiovascular Risk Factor
- Interventions
- Device: Withings ScanWatch
- Registration Number
- NCT04471636
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 607
-
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
- Participation in concurrent clinical trial
- indication for hospitalization at study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemedicine Care Withings ScanWatch 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
LMU Klinikum
🇩🇪Munich, BY, Germany