Clinical trial NCT04331171: Epidemiological Observation From a Smartphone Self-monitoring Application for Suspected COVID-19 Patients' Triage
Official title: Epidemiological Observation From a Smartphone Self-monitoring Application for Suspected COVID-19 Patients' Triage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: M-health
COVID-19
Self-assessment application
epidemiology
symptoms
Lead sponsor: Weprom
Sponsor class: OTHER
Collaborators: name: Institut Pasteur
name: Assistance Publique - Hôpitaux de Paris
name: DOCAPOST
name: Direction Générale de l'Offre de Soins
First posted: 2020-04-02
Enrollment: 12000000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All users of the https://www.maladiecoronavirus.fr/ application over the age of 18

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* not applicable

Primary outcomes:
measure: 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/
timeFrame: 12 days
measure: 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/
timeFrame: 12 days
Secondary outcomes:
measure: To assess the evolution over time of the COVID 19 epidemic
timeFrame: 3 months
measure: To assess the evolution over space of the COVID 19 epidemic
timeFrame: 3 months
measure: To assess symptoms
timeFrame: 3 months
measure: To assess the users population
timeFrame: 3 months
Other outcomes:
Locations:
city: Le Mans
country: France
facility: All French Emergency services
Study officials:
affiliation: Jean Bernard Center - LE MANS
name: Fabrice DENIS, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.