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