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

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 Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Device: Connected devices measurements

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Auvergne-Rhône-Alpes
    • Grenoble, Auvergne-Rhône-Alpes, France, 38043
      • CHU Grenoble-Alpes
  • Hauts-de-France
    • Amiens, Hauts-de-France, France, 80054
      • CHU d'Amiens
  • Ile De France
    • Saint-Mandé, Ile De France, France, 94160
      • Hôpital d'Instruction des Armées Begin
  • Ile-de-France
    • Clamart, Ile-de-France, France, 92140
      • Hôpital d'Instruction des Armées PERCY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Covid19 Patients; Patients diagnosed as COVID-19 positive and managed on an outpatient basis.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Withings

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): January 12, 2021
• Study Completion (Actual): May 12, 2021

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-A00981-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No