Ré-Conf-ISS - Réunion Island, Lockdown, Social Inequalities in Health

Head :
FIANU Adrian, CIC1410 / EQUITY (CERPOP)

Last update : 11/02/2022 | Version : 1 | ID : 73833

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Réunion Island, Lockdown, Social Inequalities in Health
Sign or acronym Ré-Conf-ISS
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation RNIPH, MR-004, INDS (MR 5219300420)
General Aspects
Medical area Psychology and psychiatry
Study in connection with Covid-19 Yes
Health determinants Geography
Social and psychosocial factors
Keywords housing conditions, self-reported health, social and geographic epidemiology, Réunion island, phone survey, Covid-19 epidemic context, residential district deprivation level
Scientific investigator(s) (Contact)
Name of the director FIANU
Surname Adrian
Address CIC de la Réunion - CHU Sud Réunion BP350 97748 St-Pierre Cedex
Phone +262 (0) 262 35 90 00
Email adrian.fianu@chu-reunion.fr
Unit CIC1410 / EQUITY (CERPOP)
Organization INSERM / CHU de la Réunion
Collaborations
Participation in projects, networks and consortia No
Others This public health research project involves a scientific partnership both with the EQUITY team from the UMR1295 in Toulouse (CERPOP - Centre d'Epidémiologie et de Recherche en santé des POPulations) and the Indian Ocean Regional Observatory of Health (ORS).
Funding
Funding status Public
Details ANR Recherche-Action Covid-19 (wave 8)
Governance of the database
Sponsor(s) or organisation(s) responsible CHU de la Réunion
Organisation status Public
Presence of scientific or steering committees Yes
Labelling and database evaluation The research project Ré-Conf-ISS was validated by the Covid-19 Scientific Restricted Board of the Réunion's CHU on 30th April 2020. The same day, the study was registered on the public directory of the INDS under the number MR 5219300420, and on the internal directory of the Data Protection Officer (DPO) of the Réunion's CHU. These regulatory proceedings were done with the help of the project manager of the Réunion's CHU DRCI.
Additional contact
Name of the contact GERARDIN
Surname Patrick (co-investigateur)
Address CIC de la Réunion - CHU Sud Réunion BP350 97748 St-Pierre Cedex
Email patrick.gerardin@chu-reunion.fr
Unit CIC1410
Organization INSERM / CHU de la Réunion
Name of the contact NATY
Surname Nadège (responsable de la plateforme d'enquête du CIC1410)
Address CIC de la Réunion - CHU Sud Réunion BP350 97748 St-Pierre Cedex
Email nadege.naty@chu-reunion.fr
Unit CIC1410
Organization INSERM / CHU de la Réunion
Name of the contact DELPIERRE
Surname Cyrille (partenaire scientifique)
Address Faculté de Médecine, Université Paul Sabatier, 37 Allées Jules Guesde, Toulouse 31000 France
Email cyrille.delpierre@inserm.fr
Unit EQUITY (CERPOP)
Organization Université de Toulouse - Paul Sabatier Toulouse 3 / INSERM
Name of the contact KELLY-IRVING
Surname Michelle (partenaire scientifique)
Address Faculté de Médecine, Université Paul Sabatier, 37 Allées Jules Guesde, Toulouse 31000 France
Email michelle.kelly@inserm.fr
Unit EQUITY (CERPOP)
Organization Université de Toulouse - Paul Sabatier Toulouse 3 / INSERM
Name of the contact RACHOU
Surname Emmanuelle (partenaire scientifique)
Address Observatoire Régional de La Santé Océan Indien, 12 Rue Colbert - 97 400 Saint-Denis
Email e.rachou@orsoi.net
Unit ORS-OI
Organization ORS-OI
Main features
Type of database
Type of database Study databases
Study databases (details) Not-repeated cross-sectional studies (except case control studies)
Database recruitment is carried out by an intermediary A population file
Database recruitment is is made on the basis of: Another treatment or procedure
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. The Ré-Conf-ISS study planed to enroll a statistical sample of 900 adult persons selected via the telephone directory within the 114 major Réunion districts as defined by the Insee Réunion-Mayotte, following the quotas of adult inhabitants for these main districts and their deprivation level (Besson 2018).
Database objective
Main objective Primary objective:

To describe, just after the lockdown implemented for tackling SARS-Cov-2 epidemic, the self-reported state of health of the Reunionese population according to the residential district deprivation level.

Secondary objectives:

- To describe, just after the lockdown event, the self-reported state of health of the Reunionese population according to the housing conditions experienced during the lockdown.

- To describe, just after the lockdown event, the self-reported state of health of the Reunionese population according to the individual socioeconomic characteristics: age class and gender, employment status and socioprofessional category, education level.

- To compare the self-reported general stress level between the regional studies conducted on Réunion island: during the lockdown event (Confin-Aou study) versus after the lockdown event (Ré-Conf-ISS study).

- To compare the psychologic impact of the lockdown event between France main land and Réunion island using the results from the Epidemic national survey and the Ré-Conf-ISS regional survey respectively.
Inclusion criteria - Major (aged 18 years and older)
- Living on the island before 17 March 2020
- Stayed on the Réunion territory within all through the lockdown event (between March 17th and May 11th)
- Without curatorship
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered General population
Pathology
Gender Male
Woman
Other
Geography area Regional
French regions covered by the database La Réunion
Detail of the geography area Enrollment of the 900 participants within the 114 reunionese major districts as defined by the Insee Réunion-Mayotte in 2018
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 05/2020
Date of last collection (YYYY or MM/YYYY) 07/2020
Size of the database
Size of the database (number of individuals) [500-1000[ individuals
Details of the number of individuals 900
Data
Database activity Data collection completed
Type of data collected Declarative data
Administrative data
Declarative data (detail) Phone interview
Details of collected declarative data The questionnaire used for the phone interview have 115 items. It comprises 7 general chapters: the individual socio-economic characteristics (education level, employment status, socioprofessional category, financial difficulties during lockdown), housing, equipment, environment close to the habitat occupied during the lockdown, the exposure to the epidemic, the psychological state (stress, anxiety, social relationships and activities during lockdown), the addictive behaviors and lifestyle, nutritional status and physical activity, as well as the healthcare use. Two specific chapters deal with potentially vulnerable sub-populations: the children health reported by the co-enrolled parent and intimate partner violence. The study main outcome is the level of stress since the beginning of the confinement period measured on a scale from 0 (total absence of stress) to 10 (maximum imaginable stress).
Administrative data (detail) Commune, postcode and residential major district
Presence of a biobank No
Health parameters studied Health event/morbidity
Health care consumption and services
Care consumption (detail) Medical/paramedical consultation
Procedures
Data collection method In the course of progressive deconfinement, a one-shot telephonic cross-sectional survey conducted on a 900 individuals sample drawned from the Reunionese population has been implemented since May 13, 2020, to describe the participants state of health according to their socioeconomic characteristics.
Classifications used Common nomenclatures: major district, typology of reunionese major districts deprivation level and socioprofessional category by the Insee. Special nomenclatures: to promote the comparison of findings between epidemiological studies, shared items were chosen from national research (Epidemic) and regional research (Confin-Aou): sociodemography, living and working conditions during the lockdown event, exposure to the SARS-Cov-2 epidemic, psychologic impact and addictive behaviours.
Quality procedure(s) used This study was designed and conducted by the clinical investigation center of la Réunion (CIC1410). Phone data collection layed on its survey platform comprising 3 creole-speaking investigators. This platform was reinforced by the enrollment of 2 temporary workers. The database development was done by a datamanager of the team using the Ennov Clinical ® software. Data hosting is ISO 9001:2008 certified. It integrates its customers' applications in a datacenter located on two mirror sites (Poitiers and Roubaix) offering optimal security conditions. Access to the datacenter is strictly controlled, uninterrupted power supply is guaranteed, weather conditions are controlled and a fire safety system is included (regularly updated and checked). The servers are protected by a firewall and an updated anti-virus system. Customer data is managed in strict compliance with the rules of confidentiality, access is controlled by SSL certificate and all exchanges are encrypted. Ennov Clinical® complies with FDA recommendations regarding "Guidance for computerized systems used in clinical trials", electronic signature ( 21 CFR Part 11?) and international standards for health data hosting. In the Ré-Conf-ISS study, access to the database is secured (personal identifier and password) with different levels of security depending on the roles assigned to users. The data are entered on the eCRF (CS Online module Ennov Clinical® software) by data entry operators of the CIC. A data entry guide is made available to operators. A data validation plan, jointly defined between the coordinating investigator and the Methodology and Data Management center, will be developed and will describe in detail the controls to be executed for each variable. The quality control of data being entered will be exhaustive. Once the entry is made, the consistency of the data will be checked, errors, omissions or inconsistencies will be mentioned (CS Tests module). The data freeze / thaw process will be performed in accordance with the procedure implemented in the Center for Methodology and Data Management.
Participant monitoring No
Followed pathology
Links to administrative sources No
Promotion and access
Promotion
Link to the document Note-de-synthese_Re-Conf-ISS_vf.pdf
Description Preliminary results of the Re-Conf-ISS study: Summary note
Link to the document ijerph-19-13932-v2.pdf
Description Main article of the study for international valorisation
Access
Presence of document that lists variables and coding procedures Yes
Terms of data access (charter for data provision, format of data, availability delay) To define
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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