Telemedicine in Outpatient Covid-19 Patients
COVID-SMART
Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients
1 other identifier
interventional
607
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Sep 2020
Longer than P75 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2020
CompletedFirst Posted
Study publicly available on registry
July 15, 2020
CompletedStudy Start
First participant enrolled
September 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJune 28, 2022
June 1, 2022
1.8 years
July 9, 2020
June 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service
Occurrence of any of the above during follow-up
30 days
Secondary Outcomes (4)
Rate of participants hospitalized
30 days
Rate of participants with unplanned use of hospital emergency department or emergency medical service
30 days
Rate of participants experiencing death of any cause
30 days
Rate of participants experiencing death of Covid-19
30 days
Study Arms (2)
Telemedicine Care
EXPERIMENTALPatients 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.
Control
NO INTERVENTIONPatients 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.
Interventions
The smart watch is capable of recording SpO2, ECG, and heart rate.
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- Participation in concurrent clinical trial
- indication for hospitalization at study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LMU Klinikum
Munich, Bavaria, 81377, Germany
Related Publications (1)
von Falkenhausen AS, Gail A, Geipel S, Scherer C, Stockhausen S, Sams LE, Becker F, Massberg S, Kaab S, Sinner MF. Symptoms of Depression and Anxiety After COVID-19 Despite Systematic Telemedical Care: Results From the Prospective COVID-SMART Study. Depress Anxiety. 2025 Apr 13;2025:9989990. doi: 10.1155/da/9989990. eCollection 2025.
PMID: 40259893DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steffen Massberg, MD
Department Head
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 9, 2020
First Posted
July 15, 2020
Study Start
September 18, 2020
Primary Completion
June 27, 2022
Study Completion
June 30, 2023
Last Updated
June 28, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share