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

Covid19 Clinical Trial

— SECURADOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04560855
• Other study ID #: 2020-A00981-38
• Status: Completed
• Start date: September 14, 2020
• Est. completion date: May 12, 2021

Study information

• Verified date: September 2020
• Source: Withings
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 12, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Device:
• Connected devices measurements
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.

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens	Hauts-de-France
France	Hôpital d'Instruction des Armées Percy	Clamart	Ile-de-France
France	CHU Grenoble-Alpes	Grenoble	Auvergne-Rhône-Alpes
France	Hôpital d'Instruction des Armées Bégin	Saint-Mandé	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Withings

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Study the evolution of daily patient parameters without aggravation over time	Slope of daily patient parameters without aggravation over time.	1 year
Secondary	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