- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04471636
Telemedicine in Outpatient Covid-19 Patients (COVID-SMART)
Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
Germany
-
BY
-
Munich, BY, Germany, 81377
- LMU Klinikum
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telemedicine Care
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.
|
The smart watch is capable of recording SpO2, ECG, and heart rate.
|
No Intervention: Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service
Time Frame: 30 days
|
Occurrence of any of the above during follow-up
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of participants hospitalized
Time Frame: 30 days
|
Occurrence of hospitalization during follow-up
|
30 days
|
Rate of participants with unplanned use of hospital emergency department or emergency medical service
Time Frame: 30 days
|
Occurrence of any of the above during follow-up
|
30 days
|
Rate of participants experiencing death of any cause
Time Frame: 30 days
|
Occurrence of death of any cause during follow-up
|
30 days
|
Rate of participants experiencing death of Covid-19
Time Frame: 30 days
|
Occurence of daeth of Covid-19 during follow-up
|
30 days
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Steffen Massberg, MD, Department head
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-448
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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