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

NCT04560855 | Completed

• 1 other identifier: 2020-A00981-38
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 4

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Study the evolution of daily patient parameters without aggravation over time

  1 year

• Subjective assessment of the connected devices

  1 year

Study Arms (1)

Covid19 Patients

Patients diagnosed as COVID-19 positive and managed on an outpatient basis.

Device: Connected devices measurements

Interventions

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.

Covid19 Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Withings: lead

Study Sites (4)

CHU Grenoble-Alpes

Grenoble, Auvergne-Rhône-Alpes, 38043, France

Location

CHU d'Amiens

Amiens, Hauts-de-France, 80054, France

Location

Hôpital d'Instruction des Armées Percy

Clamart, Île-de-France Region, 92140, France

Location

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, Île-de-France Region, 94160, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Louis Pépin, Pr

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: September 14, 2020
• Primary Completion: January 12, 2021
• Study Completion: May 12, 2021
• Last Updated: May 20, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)