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

Sponsor

Weprom (Other)

Overall Status

Completed

CT.gov ID

NCT04331171

Collaborator

Institut Pasteur (Industry), Assistance Publique - Hôpitaux de Paris (Other), DOCAPOST (Other), Direction Générale de l'Offre de Soins (Other)

12,000,000

Enrollment

Location

Actual Duration (Months)

1503086.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Device: Web application users

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

12000000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 17, 2020

Actual Primary Completion Date :

Nov 15, 2020

Actual Study Completion Date :

Nov 15, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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/ [12 days]
Number of calls to Emergency service after the launch of web application comparded to the days before
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/ [12 days]
Number of relevants calls to Emergency service after the launch of web application comparded to the days before

Secondary Outcome Measures

To assess the evolution over time of the COVID 19 epidemic [3 months]
the symptoms collected by the application
To assess the evolution over space of the COVID 19 epidemic [3 months]
the symptoms collected by the application according to ZIP code
To assess symptoms [3 months]
Descriptive analysis of symptoms collected by web-application
To assess the users population [3 months]
Descriptive analysis of data collected by web-application

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

not applicable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	All French Emergency services	Le Mans		France

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weprom

ClinicalTrials.gov Identifier:

NCT04331171

Other Study ID Numbers:

WP-2020-02

First Posted:

Apr 2, 2020

Last Update Posted:

Apr 8, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Weprom

M-health

COVID-19

Self-assessment application

epidemiology

symptoms

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 8, 2021