{"doc_desc":{"title":"Cohorte prospective multicentrique d\u2019aidants informels en Bourgogne Franche-Comt\u00e9","idno":"FRESH-PEF22906-fr","producers":[{"name":"Virginie NERICH","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF22906-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"22906"},{"agency":"FReSH","code":"FRESH-PEF22906"}]},"title":"Cohorte prospective multicentrique d\u2019aidants informels en Bourgogne Franche-Comt\u00e9","alternate_title":"Cohorte ICE (Informal Carers of Elderly)"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"},{"name":"CESREES"}]},"authoring_entity":[{"type":"investigator","name":"Astrid;POZET","PILabo":"CHU de Besan\u00e7on \/ UMQVC (INSERM 1098)","affiliationName":"CHU BESANCON (CHU)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"262501760","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"apozet@chu-besancon.fr","isContact":"Oui"}],"oth_id":[{"name":"CHU de Besan\u00e7on-CHU de Dijon-Centre Georges Fran\u00e7ois Leclerc-P\u00f4le de G\u00e9rontologie et d'innovation-Universit\u00e9 de Bourgogne-Franche-Comt\u00e9","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CHU BESANCON (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0084te143","role":"sponsor id"},{"title":"SIREN","uri":"804366995","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]},{"name":"CAISSE NATIONALE DE SOLIDARITE POUR L'AUTONOMIE (CNSA)","extlink":[]},{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]},{"name":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rkrv905"},{"title":"SIREN","uri":"775664717"}]}]},"distribution_statement":{"contact":[{"name":"Virginie;NERICH","email":"v1nerich@chu-besancon.fr","type":"contact","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0084te143","role":"organisation id","title":"ROR"},{"uri":"262501760","role":"organisation id","title":"SIREN"}]},{"name":"Astrid;POZET","email":"apozet@chu-besancon.fr","type":"contact","affiliationName":"CHU BESANCON (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0084te143","role":"organisation id","title":"ROR"},{"uri":"262501760","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Aidants informels-Maladie chronique -Personnes \u00e2g\u00e9es- Intervention - Qualit\u00e9 de Vie - Parcours de soins - Travailleur social"}],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"topic":"Cardiologie et m\u00e9decine vasculaire","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D002309"}]},{"topic":"G\u00e9riatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d37e4d8c-a978-40c7-ba4f-eee841851073"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005853"}]},{"topic":"Neurologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Ophtalmologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/621ef1ce-2ebd-43d9-a6c7-ecd962d27269"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009885"}]},{"topic":"Andrologie et urologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7341b8bd-fcb0-44c1-9ca9-8752b542ed59"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d90d8dbf-c4b3-46c0-bf2c-55a4a3d9ba8b"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D033441"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D014572"}]},{"topic":"N\u00e9phrologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009398"}]},{"topic":"Accident vasculaire c\u00e9r\u00e9bral, non pr\u00e9cis\u00e9 comme \u00e9tant h\u00e9morragique ou isch\u00e9mique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1442995018","title":"CIM-11"}]},{"topic":"Insuffisance cardiaque","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1458683894","title":"CIM-11"}]},{"topic":"Syndromes parkinsoniens","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/2024168133","title":"CIM-11"}]},{"topic":"D\u00e9mence due \u00e0 une maladie \u00e0 corps de Lewy","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1777436789","title":"CIM-11"}]},{"topic":"Maladie d'Alzheimer","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1611724421","title":"CIM-11"}]},{"topic":"D\u00e9mence due \u00e0 une maladie c\u00e9r\u00e9brovasculaire","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1365258270","title":"CIM-11"}]},{"topic":"D\u00e9mence frontotemporale","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/831337417","title":"CIM-11"}]},{"topic":"Tumeurs malignes du sein","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1047754165","title":"CIM-11"}]},{"topic":"Tumeurs malignes de la prostate","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1552457716","title":"CIM-11"}]},{"topic":"Tumeurs malignes du c\u00f4lon","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1265576634","title":"CIM-11"}]},{"topic":"Tumeurs malignes du rectum","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1113099195","title":"CIM-11"}]},{"topic":"D\u00e9g\u00e9n\u00e9rescence maculaire li\u00e9e \u00e0 l'\u00e2ge","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1514301548","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"Autre","vocab":"health determinant"}],"purpose":"Le projet fera la place \u00e0 trois types d\u2019\u00e9tudes : une \u00e9tude descriptive, une \u00e9tude interventionnelle et des \u00e9tudes ancillaires. Etude descriptive : Objectif principal : Identifier les profils longitudinaux des aidants de personnes \u00e2g\u00e9es de 60 ans et plus durant les cinq premi\u00e8res ann\u00e9es de leur entr\u00e9e dans ce r\u00f4le, \u00e0 partir de l\u2019\u00e9valuation de leur qualit\u00e9 de vie relative \u00e0 la sant\u00e9 (MOS SF 36, CarGoQol) ; leurs strat\u00e9gies d\u2019adaptation au stress (Questionnaire de Borteyrou, Rascle et Truchot) ; leur anxi\u00e9t\u00e9 \u2013 d\u00e9pression (HADs) ; leur soutien social (SSQ6) et leur charge ressentie (inventaire de Zarit) Objectifs secondaires : \u00ad Evaluer la relation aidant - patient selon une approche qualitative ; \u00ad Identifier la sp\u00e9cificit\u00e9 de l\u2019aide dans les situations o\u00f9 le patient pr\u00e9sente des troubles comportementaux (d\u00e9mences de type Alzheimer en particulier) ; \u00ad Etudier les situations de rupture dans la relation aidant - patient (entr\u00e9e en institution, d\u00e9c\u00e8s, r\u00e9mission du patient). Etude interventionnelle (essai randomis\u00e9 d\u2019intervention) : Objectif principal : Comparer le niveau de qualit\u00e9 de vie (dimensions : sant\u00e9 physique et mentale) du MOS SF36 \u00e0 un an et \u00e0 deux ans selon l\u2019intervention allou\u00e9e par la randomisation. Objectifs secondaires : \u00ad Comparer les autres dimensions de la qualit\u00e9 de vie du MOS SF 36 \u00e0 un an et \u00e0 deux ans selon l\u2019intervention ; \u00ad Comparer longitudinalement l\u2019ensemble des dimensions de qualit\u00e9 de vie du MOS SF36 et du CargoQol (uniquement pour le groupe de pathologies canc\u00e9reuses) selon l\u2019intervention ; \u00ad Comparer longitudinalement les strat\u00e9gies d\u2019adaptation au stress (Questionnaire de Borteyrou, Rascle et Truchot), l\u2019anxi\u00e9t\u00e9-d\u00e9pression (HADs), le soutien social (SSQ6) et la charge ressentie (inventaire de Zarit) selon l\u2019intervention ; \u00ad \u00c9valuer d\u2019un point de vue soci\u00e9tal, l\u2019impact pour l\u2019aidant de l\u2019intervention d\u2019un travailleur social en termes de co\u00fbt (questionnaire \u00e9conomique) et d\u2019utilit\u00e9 (SF-6D et EQ-5D). Par ailleurs, le score d\u2019anxi\u00e9t\u00e9-d\u00e9pression (CES-D) sera estim\u00e9 afin d\u2019\u00e9clairer les r\u00e9sultats obtenus en termes d\u2019utilit\u00e9. Etudes ancillaires : \u00ad Portant sur la qualit\u00e9 de vie -Validation de l\u2019\u00e9chelle sp\u00e9cifique CarGoQol ; -Qualit\u00e9 de vie sexuelle du conjoint et du couple apr\u00e8s traitement \u00e0 vis\u00e9e curative d\u2019un cancer de la prostate localis\u00e9 ; -Comparaison des crit\u00e8res de qualit\u00e9 de vie des patients trait\u00e9s pour une DMLA et de leurs aidants au cours du traitement ; \u00ad Portant sur les facteurs de risque -D\u00e9termination du profil de risque cardio-neuro-vasculaire chez les aidants ; -Evaluation du risque suicidaire chez les aidants ; \u00ad Portant sur la nutrition -Evolution de la qualit\u00e9 nutritionnelle du duo aidant \/ patient de plus de 65 ans ; -Comparaison des r\u00e9gimes alimentaires chez les patients atteints d\u2019une DMLA et de leurs aidants et influence de l\u2019annonce du diagnostic sur ce r\u00e9gime.","abstract":"","coll_dates":[{"start":"2015-01-01","end":"2021-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Bourgogne Franche-Comt\u00e9']","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    \"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\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Pour \u00eatre \u00e9ligible, l\u2019aidant principal doit : \u00adappartenir \u00e0 l\u2019entourage proche de l\u2019aid\u00e9 (famille, amis, voisins) ; \u00adremplir le questionnaire d\u2019auto-d\u00e9signation  ou \u00eatre identifi\u00e9 par le patient  comme \u00ab aidant principal \u00bb gr\u00e2ce \u00e0 un questionnaire de d\u00e9signation de l\u2019aidant principal ; \u00ad\u00eatre \u00e2g\u00e9 d\u2019au moins 18 ans ; \u00adne pas \u00eatre salari\u00e9 d\u2019une structure qui assure l\u2019aide ; \u00ad\u00eatre domicili\u00e9 en r\u00e9gion Bourgogne - Franche-Comt\u00e9 ;         \u00eatre en capacit\u00e9 de r\u00e9pondre \u00e0 des questionnaires.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es \u00e9conomiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Consommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue\r\nAutres"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d&#x27;exercice lib\u00e9ral Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"186"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"12-02-2015","lastUpdatedAuto":null,"lastUpdatedManual":"18-09-2020","isContributorPI":"Non","contributorName":"Virginie NERICH","contributorAffiliation":"UNIVERSITE MARIE ET LOUIS PASTEUR (UMLP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Industrie","Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Auto-questionnaire papier ou \u00e9lectronique","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Bourgogne - Franche-Comt\u00e9"},"dataTypes":{"clinicalDataDetails":"Donn\u00e9es cliniques du patient (date du diagnostic de la pathologie chronique, type de pathologie chronique)","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}