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

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ClinicalTrials.gov Identifier: NCT04331171
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : April 17, 2020
Sponsor:
Collaborators:
Institut Pasteur
Assistance Publique - Hôpitaux de Paris
DOCAPOST
Direction Générale de l'Offre de Soins
Information provided by (Responsible Party):
Weprom

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
COVID-19 Device: Web application users

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Epidemiological Observation From a Smartphone Self-monitoring Application for Suspected COVID-19 Patients' Triage
Actual Study Start Date : March 17, 2020
Actual Primary Completion Date : March 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. To assess the evolution over time of the COVID 19 epidemic [ Time Frame: 3 months ]
    the symptoms collected by the application

  2. 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. To assess symptoms [ Time Frame: 3 months ]
    Descriptive analysis of symptoms collected by web-application

  4. To assess the users population [ Time Frame: 3 months ]
    Descriptive analysis of data collected by web-application



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All users of the https://www.maladiecoronavirus.fr/ application over the age of 18
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331171


Contacts
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Contact: Fabrice DENIS, MD 241682940 ext 0033 f.denis@cjb72.org

Locations
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France
All French Emergency services Recruiting
Le Mans, France
Contact: Fabrice DENIS, MD         
Principal Investigator: Fabrice DENIS, MD         
Sponsors and Collaborators
Weprom
Institut Pasteur
Assistance Publique - Hôpitaux de Paris
DOCAPOST
Direction Générale de l'Offre de Soins
Investigators
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Study Director: Fabrice DENIS, MD Jean Bernard Center - LE MANS

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Responsible Party: Weprom
ClinicalTrials.gov Identifier: NCT04331171    
Other Study ID Numbers: WP-2020-02
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weprom:
M-health
COVID-19
Self-assessment application
epidemiology
symptoms