Secure Self-monitoring Through a Combination of Connected Objects: Implementation in COVID-19 Patients Monitored at Home
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Withings
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- Sensitivity and Specificity of the patient's aggravation with a cluster model
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Study the evolution of daily patient parameters without aggravation over time(1 year)
- Subjective assessment of the connected devices(1 year)