Covid-19COVID-SMARTNCT04471636
Telemedicine in Outpatient Covid-19 Patients
A study testing Withings ScanWatch in people with Covid-19 and Cardiovascular Risk Factor, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Cardiovascular Risk Factor
- What is being tested?
- Withings ScanWatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 1 siteGermany
- Study dates
- 18 Sep 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 16Show fewer
- 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
Who cannot join
- Participation in concurrent clinical trial
- indication for hospitalization at study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Covid-19, Cardiovascular Risk Factor
- Being tested
- Withings ScanWatch
- Keywords
- SARS-CoV2, Covid-19, cardiovascular disease, telemedicine, ECG, SpO2
- Medical subject headings
- COVID-19, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withings ScanWatchDevice
The smart watch is capable of recording SpO2, ECG, and heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Care | Experimental | 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. Receives: Device: Withings ScanWatch |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (4)
Rate of participants hospitalized
Occurrence of hospitalization during follow-up
Measured: 30 days
Rate of participants with unplanned use of hospital emergency department or emergency medical service
Occurrence of any of the above during follow-up
Measured: 30 days
Rate of participants experiencing death of any cause
Occurrence of death of any cause during follow-up
Measured: 30 days
Rate of participants experiencing death of Covid-19
Occurence of daeth of Covid-19 during follow-up
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start18 Sep 2020
- Primary completion27 Jun 2022
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Gesundheitsreferat (GSR), Landeshauptstadt München, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Principal investigator, Moritz F. Sinner, Ludwig-Maximilians - University of Munich
- Investigators
- Steffen Massberg, MD, Study director, Department Head
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471636
- Sponsor's protocol ID
- 20-448
- Acronym
- COVID-SMART
- Status last verified
- Jun 2022
- First submitted
- 9 Jul 2020
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40259893
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients
- ClinicalTrials.gov ID
- NCT04471636
- Acronym / sponsor ID
- COVID-SMART / 20-448
- Conditions
- Covid-19, Cardiovascular Risk Factor
- Keywords
- SARS-CoV2, Covid-19, cardiovascular disease, telemedicine, ECG, SpO2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 607 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Gesundheitsreferat (GSR), Landeshauptstadt München, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Care | Experimental | Device: Withings ScanWatchPatients 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 intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Confirmed SARS-CoV2 infection and clinical Covid-19 disease
- age ≥18 years
- Presence of ≥1 relevan cardiovascular condition, defined as (or):
- availability of smartphone and sufficient internet connectivity at home
- ability to use smartwatch
Key exclusion criteria (2 listed)
- Participation in concurrent clinical trial
- indication for hospitalization at study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withings ScanWatchThe smart watch is capable of recording SpO2, ECG, and heart rate. | Device | Telemedicine Care |
Primary outcome
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
4 secondary outcomes
Rate of participants hospitalized
Time frame: 30 days
Rate of participants with unplanned use of hospital emergency department or emergency medical service
Time frame: 30 days
Rate of participants experiencing death of any cause
Time frame: 30 days
Rate of participants experiencing death of Covid-19
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Derived from this study: PubMed 40259893von 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Massberg, MD study director
Department Head
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withings ScanWatch in people with Covid-19 and Cardiovascular Risk Factor, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.