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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble-Alpes, Grenoble, Auvergne-Rhône-Alpes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Connected devices measurements

Device

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.

Primary outcomes

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

Secondary outcomes

Study the evolution of daily patient parameters without aggravation over time

Time frame: 1 year

Slope of daily patient parameters without aggravation over time.
Subjective assessment of the connected devices

Time frame: 1 year

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 -).

Sponsors and collaborators

Lead sponsor

Withings

Industry

Registry information

Acronym: SECURADOM

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Sep 23, 2020
Registry last updated: May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed