Epidemiological Observation From a Smartphone Self-monitoring Application for Suspected COVID-19 Patients' Triage (COVID CALL 15)

April 6, 2021 updated by: Weprom

A coronavirus pandemic began on 12/31/2020 with the first Chinese patient. As of 3/16/2020, the epidemic affects more than 100 countries with 169,000 official infections and 6,500 deaths. This virus causes a pathology ranging from simple flu symptoms in 80% of cases to acute respiratory distress syndromes requiring resuscitation in 5% of cases and a death rate of 1.4 to 4% of cases.

The arrival in France on 02/25/2020 with an exponential development of the infection (more than 5,000 cases on 03/15/2020) was accompanied by an unprecedented number of calls to the French emergency service call number (15) of worried patients with overload and sometimes saturation of the service that can impact calls and the care of patients really recovering from an emergency.

We previously developed a Moovcare® web application which showed a 7 months survival benefit by early detection of relapsed lung cancer based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 trial randomized. Another application for detecting and monitoring chemo-induced febrile aplasia appears to show a reduction in the number of hospitalizations for sepsis. Finally, Smokecheck, a self-assessment application for symptoms by smokers, has shown that it improves the detection of symptomatic operable bronchial cancers (9 to 24%, p = 0.04).

The web application https://www.maladiecoronavirus.fr/ was developed with a group of physicians from the Institut Pasteur, Hospitals group of Paris, Hospitals of Lille and Rennes and the ILC Jean Bernard in Le Mans. It makes it possible to guide symptomatic patients and patients who wishing to know what to do (call their general practitioner, teleconsultation, or call emergency service) based on symptoms and predictive factors of severity.

Following the availability of this new tool, we want to assess the impact of the application on the number and relevance of calls to emergency service.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Mans, France
        • All French Emergency services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All users of the https://www.maladiecoronavirus.fr/ application over the age of 18

Description

Inclusion Criteria:

  • All users of the https://www.maladiecoronavirus.fr/ application over the age of 18

Exclusion Criteria:

  • not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Web-application users
questionnaire of comorbidity and symptomes completed by the user on his smartphone
Device: Web application users
questionnaire of comorbidity and symptoms completed by the patient on his smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess of the evolution of the number of calls to Emergency service within 12 days after the launch of the application https://www.maladiecoronavirus.fr/
Time Frame: 12 days
Number of calls to Emergency service after the launch of web application comparded to the days before
12 days
To assess of the evolution of the proportion of relevant calls to Emergency service within 12 days after the launch of the application https://www.maladiecoronavirus.fr/
Time Frame: 12 days
Number of relevants calls to Emergency service after the launch of web application comparded to the days before
12 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the evolution over time of the COVID 19 epidemic
Time Frame: 3 months
the symptoms collected by the application
3 months
To assess the evolution over space of the COVID 19 epidemic
Time Frame: 3 months
the symptoms collected by the application according to ZIP code
3 months
To assess symptoms
Time Frame: 3 months
Descriptive analysis of symptoms collected by web-application
3 months
To assess the users population
Time Frame: 3 months
Descriptive analysis of data collected by web-application
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weprom

Collaborators

Assistance Publique - Hôpitaux de Paris
Institut Pasteur
DOCAPOST
Direction Générale de l'Offre de Soins

Investigators

  • Study Director: Fabrice DENIS, MD, Jean Bernard Center - LE MANS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2020

Primary Completion (Actual)

November 15, 2020

Study Completion (Actual)

November 15, 2020

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WP-2020-02

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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