{"doc_desc":{"title":"R\u00e9union, Confinement, In\u00e9galit\u00e9s Sociales de Sant\u00e9","idno":"FRESH-PEF73833-fr","producers":[{"name":"Adrian FIANU","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73833-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73833"},{"agency":"FReSH","code":"FRESH-PEF73833"}]},"title":"R\u00e9union, Confinement, In\u00e9galit\u00e9s Sociales de Sant\u00e9","alternate_title":"R\u00e9-Conf-ISS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Patrick;GERARDIN","PILabo":"","affiliationName":"UNIVERSITE DE LA REUNION","extlink":[{"title":"ORCID","uri":"0000-0002-3276-5919","role":"pi id"},{"title":"IdRef","uri":"071614257","role":"pi id"},{"title":"SIREN","uri":"199744780","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"patrick.gerardin@chu-reunion.fr","isContact":"Oui"}],"oth_id":[{"name":"Ce projet de recherche en sant\u00e9 publique a fait l'objet d'un partenariat scientifique avec l\u2019\u00e9quipe EQUITY de l'UMR1295 \u00e0 Toulouse (CERPOP - Centre d'Epid\u00e9miologie et de Recherche en sant\u00e9 des POPulations) et l\u2019Observatoire R\u00e9gional de la Sant\u00e9 (ORS) de La R\u00e9union.","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","role":"sponsor","extlink":{"title":"ROR","uri":"https:\/\/ror.org\/004dan487","role":"sponsor id"}}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"}}]},"distribution_statement":{"contact":[{"name":"Nad\u00e8ge;NATY","email":"nadege.naty@chu-reunion.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/004dan487","role":"organisation id","title":"ROR"},{"uri":"200030013","role":"organisation id","title":"SIREN"}]},{"name":"Adrian;FIANU","email":"adrian.fianu@chu-reunion.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]},{"name":"Emmanuelle;RACHOU","email":"e.rachou@orsoi.net","type":"contact","affiliationName":"OBSERVATOIRE REGIONAL DE LA SANTE DE LA REUNION (ORS REUNION)","contactPointLabo":"","extlink":[{"uri":"393656137","role":"organisation id","title":"SIREN"}]},{"name":"Patrick;GERARDIN","email":"patrick.gerardin@chu-reunion.fr","type":"contact","affiliationName":"UNIVERSITE DE LA REUNION","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/005ypkf75","role":"organisation id","title":"ROR"},{"uri":"199744780","role":"organisation id","title":"SIREN"}]},{"name":"Cyrille;DELPIERRE","email":"cyrille.delpierre@inserm.fr","type":"contact","affiliationName":"UNIVERSITE DE TOULOUSE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01ahyrz84","role":"organisation id","title":"ROR"},{"uri":"938271392","role":"organisation id","title":"SIREN"}]},{"name":"Michelle;KELLY-IRVING","email":"michelle.kelly@inserm.fr","type":"contact","affiliationName":"UNIVERSITE DE TOULOUSE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01ahyrz84","role":"organisation id","title":"ROR"},{"uri":"938271392","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"conditions de logement"},{"keyword":"sant\u00e9 d\u00e9clar\u00e9e"},{"keyword":"\u00e9pid\u00e9miologie g\u00e9ographique et sociale"},{"keyword":"\u00eele de la R\u00e9union"},{"keyword":"contexte \u00e9pid\u00e9mique Covid-19"},{"keyword":"enqu\u00eate t\u00e9l\u00e9phonique"},{"keyword":"pr\u00e9carit\u00e9 du quartier de r\u00e9sidence"}],"topics":[{"topic":"Gastroent\u00e9rologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005762"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"}],"purpose":"Objectif principal : D\u00e9crire, au d\u00e9cours du confinement mis en place pour lutter contre l\u2019\u00e9pid\u00e9mie de SARS-CoV-2, l\u2019\u00e9tat de sant\u00e9 d\u00e9clar\u00e9 de la population r\u00e9unionnaise selon le niveau de pr\u00e9carit\u00e9 du quartier de r\u00e9sidence. Objectifs secondaires : - D\u00e9crire, au d\u00e9cours du confinement, l\u2019\u00e9tat de sant\u00e9 d\u00e9clar\u00e9 de la population r\u00e9unionnaise selon les conditions de logement pendant le confinement. - D\u00e9crire, au d\u00e9cours du confinement, l\u2019\u00e9tat de sant\u00e9 d\u00e9clar\u00e9 de la population r\u00e9unionnaise selon les caract\u00e9ristiques socio-\u00e9conomiques individuelles : classes d\u2019\u00e2ge et genre, statut par rapport \u00e0 l\u2019emploi et cat\u00e9gorie socio-professionnelle, niveau d\u2019\u00e9tude. - Comparer le niveau de stress g\u00e9n\u00e9ral d\u00e9clar\u00e9 dans les \u00e9tudes r\u00e9gionales men\u00e9es \u00e0 la R\u00e9union, pendant le confinement (\u00e9tude Confin-Aou) versus au d\u00e9cours du confinement (\u00e9tude R\u00e9-Conf-ISS). - Comparer l\u2019impact psychologique du confinement entre la m\u00e9tropole et la R\u00e9union \u00e0 partir des r\u00e9sultats de l\u2019enqu\u00eate nationale Epidemic et ceux de l\u2019enqu\u00eate r\u00e9gionale R\u00e9-Conf-ISS.","abstract":"","coll_dates":[{"start":"2020-01-01","end":"2020-12-31"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['La R\u00e9union']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        },\n        {\n            \"value\": \"Autre\",\n            \"concept\": {\n                \"vocab\": [],\n                \"vocabURI\": []\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": [\n        \"Population g\u00e9n\u00e9rale\"\n    ],\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Majeur (\u00e2ge\u2265 18 ans) - R\u00e9sidant sur l\u2019\u00eele avant le 17 mars 2020 - Ayant v\u00e9cu la totalit\u00e9 de l\u2019\u00e9pisode du confinement (entre le 17 mars et le 11 mai 2020) sur le territoire r\u00e9unionnais - Sans curatelle\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"['Nomenclatures communes : grand quartier, typologie de la pr\u00e9carit\u00e9 des grands quartiers r\u00e9unionnais et cat\u00e9gorie socioprofessionnelle selon l\\'Insee. Nomenclatures particuli\u00e8res : pour favoriser la comparaison des r\u00e9sultats entre \u00e9tudes \u00e9pid\u00e9miologiques, des items ont \u00e9t\u00e9 choisis pour \u00eatre communs avec ceux de recherches nationale (Epidemic) et r\u00e9gionale (Confin-Aou) : sociod\u00e9mographie, conditions de vie et de travail pendant le confinement, exposition \u00e0 l\\'\u00e9pid\u00e9mie de SARS-CoV-2, retentissement psychologique et conduites addictives.']","committee":"","governance":""}],"other_quality_statement":"['Cette \u00e9tude a \u00e9t\u00e9 con\u00e7ue et conduite par le centre d\\'investigation clinique de La R\u00e9union (CIC1410). Le recueil de donn\u00e9es t\u00e9l\u00e9phoniques reposait sur sa plateforme d\\'enqu\u00eate comprenant 3 secr\u00e9taires d\\'enqu\u00eate cr\u00e9olophones. Cette plateforme a \u00e9t\u00e9 renforc\u00e9e par le recrutement de 2 vacataires. Le montage de la base de donn\u00e9es a \u00e9t\u00e9 effectu\u00e9 par un data-manager de l\\'\u00e9quipe avec le logiciel Ennov Clinical\u00ae. L\u2019h\u00e9bergement des donn\u00e9es \u00e9tait certifi\u00e9 ISO 9001:2008. Dans le d\u00e9tail, Ennov h\u00e9berge les applicatifs de ses clients au sein d\u2019un datacenter localis\u00e9 sur deux sites miroirs (Poitiers et Roubaix) offrant des conditions de s\u00e9curit\u00e9 optimales. L\u2019acc\u00e8s aux locaux et aux baies de stockage est strictement contr\u00f4l\u00e9, l\u2019alimentation \u00e9lectrique est garantie sans interruption au moyen d\u2019onduleurs, les conditions climatiques sont ma\u00eetris\u00e9es et un syst\u00e8me de s\u00e9curit\u00e9 incendie est en place (toutes ces dispositions faisant l\u2019objet d\u2019audits r\u00e9guliers). Les serveurs sont prot\u00e9g\u00e9s par un firewall et un anti-virus, r\u00e9guli\u00e8rement mis \u00e0 jour. Les donn\u00e9es des clients sont g\u00e9r\u00e9es dans le strict respect des r\u00e8gles de confidentialit\u00e9, l\u2019acc\u00e8s est contr\u00f4l\u00e9 par certificat SSL et tous les \u00e9changes sont crypt\u00e9s. Ennov Clinical\u00ae respecte les recommandations de la FDA en ce qui concerne les Syst\u00e8mes Informatis\u00e9s pour la gestion des essais cliniques (\u00ab Guidance for computerized systems used in clinical trials \u00bb) et la signature \u00e9lectronique (\u00ab 21 CFR Part 11\u2033) et des normes internationales r\u00e9gissant le domaine de la sant\u00e9. Dans l\u2019\u00e9tude R\u00e9-Conf-ISS, l\u2019acc\u00e8s \u00e0 la base de donn\u00e9es \u00e9tait s\u00e9curis\u00e9 (acc\u00e8s par identifiant et mot de passe personnels) avec des niveaux de s\u00e9curit\u00e9 diff\u00e9rents en fonction des r\u00f4les attribu\u00e9s. Les donn\u00e9es ont \u00e9t\u00e9 saisies sur l\u2019eCRF (module CS Online du logiciel Ennov Clinical\u00ae) par des op\u00e9rateurs de saisie du CIC. Un guide de saisie des donn\u00e9es a \u00e9t\u00e9 mis \u00e0 disposition des op\u00e9rateurs. Un plan de validation des donn\u00e9es, d\u00e9fini conjointement entre l\u2019investigateur coordinateur et le Centre de M\u00e9thodologie et de Gestion des donn\u00e9es, a \u00e9t\u00e9 \u00e9labor\u00e9 et d\u00e9crivait de mani\u00e8re d\u00e9taill\u00e9e les contr\u00f4les \u00e0 ex\u00e9cuter pour chaque variable. Le contr\u00f4le qualit\u00e9 des donn\u00e9es en cours de saisie \u00e9tait exhaustif. Une fois la saisie effectu\u00e9e, la coh\u00e9rence des donn\u00e9es a \u00e9t\u00e9 v\u00e9rifi\u00e9e, les erreurs omissions ou incoh\u00e9rences \u00e9taient mentionn\u00e9es (module CS Tests). Le processus de gel\/d\u00e9gel des donn\u00e9es a \u00e9t\u00e9 r\u00e9alis\u00e9 conform\u00e9ment \u00e0 la proc\u00e9dure mise en place dans le Centre de M\u00e9thodologie et de Gestion des donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nConsommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Nonprobability.Quota\",\"vocab\":\"CESSDA\"},\"value\":\"Non probabiliste : quota\"}']","sample_frame":{"frame_unit":{"unit_type":"['Base de population \u00e0 finalit\u00e9 statistique']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[[]],"target_sample_size":"[500-1000[ individus","response_rate":"900"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"creationDate":"04-12-2020","lastUpdatedAuto":null,"lastUpdatedManual":"02-06-2025","isContributorPI":"Non","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Non","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Au d\u00e9cours du d\u00e9confinement progressif, une enqu\u00eate transversale t\u00e9l\u00e9phonique ponctuelle, conduite sur un \u00e9chantillon de pr\u00e8s de 900 adultes issus de la population r\u00e9unionnaise, a \u00e9t\u00e9 mise en \u0153uvre, \u00e0 partir du 13 mai 2020, pour d\u00e9crire l\u2019\u00e9tat de sant\u00e9 des participants selon leurs caract\u00e9ristiques socio-\u00e9conomiques.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Recrutement de pr\u00e8s de 900 participants au sein des 114 grands quartiers r\u00e9unionnais tels que d\u00e9finis par l'Insee R\u00e9union-Mayotte en 2018"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}