Clinical trial NCT04471636: Telemedicine in Outpatient Covid-19 Patients
Official title: Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid-19
Cardiovascular Risk Factor
Keywords: SARS-CoV2
Covid-19
cardiovascular disease
telemedicine
ECG
SpO2
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Gesundheitsreferat (GSR), Landeshauptstadt München
name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2020-07-15
Enrollment: 607
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service
timeFrame: 30 days
Secondary outcomes:
measure: Rate of participants hospitalized
timeFrame: 30 days
measure: Rate of participants with unplanned use of hospital emergency department or emergency medical service
timeFrame: 30 days
measure: Rate of participants experiencing death of any cause
timeFrame: 30 days
measure: Rate of participants experiencing death of Covid-19
timeFrame: 30 days
Other outcomes:
Locations:
city: Munich
country: Germany
facility: LMU Klinikum
state: BY
Study officials:
affiliation: Department Head
name: Steffen Massberg, MD
role: STUDY_DIRECTOR
References: