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

NCT04331171 | Completed

• 1 other identifier: WP-2020-02
• Study Type: observational
• Target: 12,000,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

M-health; COVID-19; Self-assessment application; epidemiology; symptoms

Outcome Measures

Primary Outcomes (2)

• 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/

  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/

  Number of relevants calls to Emergency service after the launch of web application comparded to the days before

  12 days

Secondary Outcomes (4)

• To assess the evolution over time of the COVID 19 epidemic

  3 months

• To assess the evolution over space of the COVID 19 epidemic

  3 months

• To assess symptoms

  3 months

• To assess the users population

  3 months

Study Arms (1)

Web-application users

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

Device: Web application users

Interventions

Web application users DEVICE

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

Web-application users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• not applicable

Sponsors & Collaborators

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

Study Sites (1)

All French Emergency services

Le Mans, France

Location

Related Publications (3)

• 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.

  PMID: 33709945 DERIVED

• 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.

  PMID: 33147165 DERIVED

• 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.

  PMID: 32496206 DERIVED

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

• Fabrice DENIS, MD

  Jean Bernard Center - LE MANS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 2, 2020
• Study Start: March 17, 2020
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)