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

NCT ID: NCT04331171

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-17

Study Completion Date

2020-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Web-application users

questionnaire of comorbidity and symptomes completed by the user on his smartphone

Web application users

Intervention Type DEVICE

questionnaire of comorbidity and symptoms completed by the patient on his smartphone

Interventions

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Web application users

questionnaire of comorbidity and symptoms completed by the patient on his smartphone

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* not applicable
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Pasteur

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

DOCAPOST

UNKNOWN

Sponsor Role collaborator

Direction Générale de l'Offre de Soins

OTHER_GOV

Sponsor Role collaborator

Weprom

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice DENIS, MD

Role: STUDY_DIRECTOR

Jean Bernard Center - LE MANS

Locations

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All French Emergency services

Le Mans, , France

Site Status

Countries

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France

References

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Denis F, Fontanet A, Le Douarin YM, Le Goff F, Jeanneau S, Lescure FX. A Self-Assessment Web-Based App to Assess Trends of the COVID-19 Pandemic in France: Observational Study. J Med Internet Res. 2021 Mar 12;23(3):e26182. doi: 10.2196/26182.

Reference Type DERIVED
PMID: 33709945 (View on PubMed)

Galmiche S, Rahbe E, Fontanet A, Dinh A, Benezit F, Lescure FX, Denis F. Implementation of a Self-Triage Web Application for Suspected COVID-19 and Its Impact on Emergency Call Centers: Observational Study. J Med Internet Res. 2020 Nov 23;22(11):e22924. doi: 10.2196/22924.

Reference Type DERIVED
PMID: 33147165 (View on PubMed)

Denis F, Galmiche S, Dinh A, Fontanet A, Scherpereel A, Benezit F, Lescure FX. Epidemiological Observations on the Association Between Anosmia and COVID-19 Infection: Analysis of Data From a Self-Assessment Web Application. J Med Internet Res. 2020 Jun 11;22(6):e19855. doi: 10.2196/19855.

Reference Type DERIVED
PMID: 32496206 (View on PubMed)

Other Identifiers

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WP-2020-02

Identifier Type: -

Identifier Source: org_study_id

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