Clinical trial NCT04560855: Secure Self-monitoring Through a Combination of Connected Objects: Implementation in COVID-19 Patients Monitored at Home
Official title: Secure Self-monitoring Through a Combination of Connected Objects: Implementation in COVID-19 Patients Monitored at Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Withings
Sponsor class: INDUSTRY
First posted: 2020-09-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and Specificity of the patient's aggravation with a logistic regression model
timeFrame: 1 year
measure: Sensitivity and Specificity of the patient's aggravation with a cluster model
timeFrame: 1 year
Secondary outcomes:
measure: Study the evolution of daily patient parameters without aggravation over time
timeFrame: 1 year
measure: Subjective assessment of the connected devices
timeFrame: 1 year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
state: Auvergne-Rhône-Alpes
city: Amiens
country: France
facility: CHU d'Amiens
state: Hauts-de-France
city: Saint-Mandé
country: France
facility: Hôpital d'Instruction des Armées Bégin
state: Ile De France
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
state: Ile-de-France
Study officials:
affiliation: CHU Grenoble Alpes
name: Jean-Louis Pépin, Pr
role: PRINCIPAL_INVESTIGATOR
References: