NCT05124145

Brief Summary

As few data are available on the epidemiology of the COVID-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the French region Auvergne-Rhône-Alpes (Aura), able to monitor the evolution of the current epidemic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

November 16, 2021

Last Update Submit

November 17, 2021

Conditions

Primary Care : Suspected and Confirmed Cases of COVID-19Primary Health CareCOVID-19 Pandemic

Keywords

COVID-19Primary careClinical epidemiologyPractice assessment

Outcome Measures

Primary Outcomes (1)

  • Estimation of the weekly incidence of COVID-19 confirmed cases

    Confirmed cases will be defined by the positivity of the detection of SARS-CoV-2 in RT-PCR and possibly by serology (for patients in whom a test is performed). The incidence rate of confirmed cases will be estimated from the number of new cases confirmed by a positive biological test reported in the patient population of the participating facilities.

    30 days after the COVID-19 suspected

Study Arms (1)

surveillance network

The surveillance network is made of 200 health professionals from 85 practices

Other: No intervention (surveillance system)

Interventions

No intervention (surveillance system)OTHER

The surveillance network will collect data on all consecutive COVID-19 cases

surveillance network

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting a health professional in primary care in the AURA region, by physical encounter, visio-consultation or telephone call, during the COVID-19 epidemics period

You may qualify if:

  • Suspect or confirmed COVID-19 case consulting in primary care in the Aura region

You may not qualify if:

  • Patient with a COVID-19 diagnosis excluded after clinical examination or investigation.
  • Patient refusing to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RESHAPE

Lyon, 69373, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Laurent LETRILLART, MD, PhD

    Research on Healthcare Performance Lab U1290

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 17, 2021

Study Start

April 1, 2020

Primary Completion

November 2, 2020

Study Completion

November 5, 2021

Last Updated

November 26, 2021

Record last verified: 2021-11

Locations

FR(1)