Covid19SECURADOMNCT04560855
Secure Self-monitoring Through a Combination of Connected Objects: Implementation in COVID-19 Patients Monitored at Home
An observational study of Covid19, run by Withings at 4 sites in France.
Trial summary
Currently, COVID+ infected patients who are on ambulatory home monitoring self-assess their health status simply by completing questionnaires and measuring their temperature twice a day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Connected devices measurements
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 4 sitesFrance
- Study dates
- 14 Sep 2020to 12 May 2021
- Phase
- Observational
- 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
Study population: Patient diagnosed COVID positive with RT-PCR positive or very suggestive symptoms and a contagion (contact with sick subjects) that can be managed on an outpatient basis.
Who may be able to join
- Adults, men and women, 18 y/o or more
- Patient diagnosed COVID positive with RT-PCR positive or very suggestive symptoms and a contagion (contact with sick subjects) that can be managed on an outpatient basis.
- Patient in possession of a smartphone (with Android or iOS) allowing the installation of the Withings Health Mate application
- Patient with access to an internet connection for the use of Withings connected products at the containment site
- Voluntary patient who has not objected to his or her participation
- Patient affiliated to or beneficiary of a social security scheme
Who cannot join
- Pregnant Women
- Patient with severe symptoms requiring hospitalization as recommended by the French Ministry of Health (23/03/2020)
- Patient without social protection or affiliated to the AME (State Medical Aid)
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curatorship) Articles L1121-5 to L1121-8
- Patient who, in the judgment of the investigator, may not be cooperative or respectful of the obligations inherent to participation in the study.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU d'Amiens
Amiens, Hauts-de-France, 80054
Hôpital d'Instruction des Armées Percy
Clamart, Île-de-France Region, 92140
CHU Grenoble-Alpes
Grenoble, Auvergne-Rhône-Alpes, 38043
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, Île-de-France Region, 94160
About this study
Currently, COVID+ infected patients who are on ambulatory home monitoring self-assess their health status simply by completing questionnaires and measuring their temperature twice a day. The SECURADOM project proposes to facilitate the follow-up of COVID+ or suspected COVID+ infected patients, followed at home, by collecting clinical signs on a telephone application and to monitor physiological safety parameters (respiratory rate, heart rate, temperature, blood pressure, activity) using connected objects developed by the company WITHINGS. This daily monitoring, which can be transmitted by patients to the doctors in charge of their surveillance, will improve the quality and safety of home monitoring.
- Conditions
- Covid19
- Being tested
- Connected devices measurements
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected devices measurementsDevice
The patient has to measure everyday several vital parameters like respiration and heart rate during the night with Withings Sleep, temperature with Withings Thermo, arterial pressure with Withings Tensiometer and physical activity with Withings smartwatch.
| Study group | Role | What they receive |
|---|---|---|
| Covid19 Patients | Patients diagnosed as COVID-19 positive and managed on an outpatient basis. Receives: Device: Connected devices measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of the patient's aggravation with a logistic regression model
The sensitivity and specificity of a logistic regression model based on the vital parameters retrieved from the connected devices will be calculated in order to evaluate its performance
Measured: 1 year
Sensitivity and Specificity of the patient's aggravation with a cluster model
The sensitivity and specificity of a cluster model based on the vital parameters retrieved from the connected devices will be calculated in order to evaluate its performance
Measured: 1 year
Secondary outcomes (2)
Study the evolution of daily patient parameters without aggravation over time
Slope of daily patient parameters without aggravation over time.
Measured: 1 year
Subjective assessment of the connected devices
The UX meCUE Scale (User eXperience modular evaluation of key Components of User Experience) questionnaire will be used. It is composed of 16 items where the participant has to answer if he agrees or not with the statement (from 0 - don't agree - to 6 - strongly agree -).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start14 Sep 2020
- Primary completion12 Jan 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pépin, Pr, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560855
- Sponsor's protocol ID
- 2020-A00981-38
- Acronym
- SECURADOM
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 20 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secure Self-monitoring Through a Combination of Connected Objects: Implementation in COVID-19 Patients Monitored at Home
- ClinicalTrials.gov ID
- NCT04560855
- Acronym / sponsor ID
- SECURADOM / 2020-A00981-38
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 23 Sep 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.
Currently, COVID+ infected patients who are on ambulatory home monitoring self-assess their health status simply by completing questionnaires and measuring their temperature twice a day. The SECURADOM project proposes to facilitate the follow-up of COVID+ or suspected COVID+ infected patients, followed at home, by collecting clinical signs on a telephone application and to monitor physiological safety parameters (respiratory rate, heart rate, temperature, blood pressure, activity) using connected objects developed by the company WITHINGS. This daily monitoring, which can be transmitted by patients to the doctors in charge of their surveillance, will improve the quality and safety of home monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid19 Patients | – | Device: Connected devices measurementsPatients diagnosed as COVID-19 positive and managed on an outpatient basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient diagnosed COVID positive with RT-PCR positive or very suggestive symptoms and a contagion (contact with sick subjects) that can be managed on an outpatient basis.
Key inclusion criteria (6 listed)
- Adults, men and women, 18 y/o or more
- Patient diagnosed COVID positive with RT-PCR positive or very suggestive symptoms and a contagion (contact with sick subjects) that can be managed on an outpatient basis.
- Patient in possession of a smartphone (with Android or iOS) allowing the installation of the Withings Health Mate application
- Patient with access to an internet connection for the use of Withings connected products at the containment site
- Voluntary patient who has not objected to his or her participation
Key exclusion criteria (5 listed)
- Pregnant Women
- Patient with severe symptoms requiring hospitalization as recommended by the French Ministry of Health (23/03/2020)
- Patient without social protection or affiliated to the AME (State Medical Aid)
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curatorship) Articles L1121-5 to L1121-8
- Patient who, in the judgment of the investigator, may not be cooperative or respectful of the obligations inherent to participation in the study.
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 |
|---|---|---|
| Connected devices measurementsThe patient has to measure everyday several vital parameters like respiration and heart rate during the night with Withings Sleep, temperature with Withings Thermo, arterial pressure with Withings Tensiometer and physical activity with Withings smartwatch. | Device | Covid19 Patients |
Primary outcome
Sensitivity and Specificity of the patient's aggravation with a logistic regression model
Time frame: 1 year
The sensitivity and specificity of a logistic regression model based on the vital parameters retrieved from the connected devices will be calculated in order to evaluate its performance
Sensitivity and Specificity of the patient's aggravation with a cluster model
Time frame: 1 year
The sensitivity and specificity of a cluster model based on the vital parameters retrieved from the connected devices will be calculated in order to evaluate its performance
2 secondary outcomes
Study the evolution of daily patient parameters without aggravation over time
Time frame: 1 year
Subjective assessment of the connected devices
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- 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.
Jean-Louis Pépin, Pr principal investigator
CHU Grenoble Alpes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Withings at 4 sites in France.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and Specificity of the patient's aggravation with a logistic regression model (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2021.