Telemedicine in Outpatient Covid-19 Patients (COVID-SMART)

Ludwig Maximilian University of Munich

Status: Active, not recruiting

Conditions: Covid-19; Cardiovascular Risk Factor

Treatments: Device: Withings ScanWatch

Study type: Interventional

Funder types: Other

Identifiers

NCT04471636

20-448

Details and patient eligibility

About

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.

Enrollment: 607 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

607 participants in 2 patient groups

Telemedicine Care

Experimental group

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.

Treatment:

Device: Withings ScanWatch

Control

No Intervention group

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.