Secure Self-monitoring Through a Combination of Connected Objects: Implementation in COVID-19 Patients Monitored at Home

Study Overview
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Brief Summary
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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.

Official Title
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Secure Self-monitoring Through a Combination of Connected Objects: Implementation in COVID-19 Patients Monitored at Home

Conditions
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Covid19

Intervention / Treatment
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* Device: Connected devices measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid19 Patients<br>Patients diagnosed as COVID-19 positive and managed on an outpatient basis. | Device: Connected devices measurements<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the evolution of daily patient parameters without aggravation over time | Slope of daily patient parameters without aggravation over time. | 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 -). | 1 year |