{"doc_desc":{"title":"Fragilit\u00e9 chez les personnes vivant avec le VIH \u00e2g\u00e9es de 70 ans et plus : faisabilit\u00e9 du d\u00e9pistage de la fragilit\u00e9, pr\u00e9valence, facteurs de risque et impact sur la survenue d\u2019\u00e9v\u00e9nements p\u00e9joratifs de sant\u00e9","idno":"FRESH-PEF73421-fr","producers":[{"name":"Mariem RAHO","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73421-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73421"},{"agency":"FReSH","code":"FRESH-PEF73421"}]},"title":"Fragilit\u00e9 chez les personnes vivant avec le VIH \u00e2g\u00e9es de 70 ans et plus : faisabilit\u00e9 du d\u00e9pistage de la fragilit\u00e9, pr\u00e9valence, facteurs de risque et impact sur la survenue d\u2019\u00e9v\u00e9nements p\u00e9joratifs de sant\u00e9","alternate_title":"ANRS EP66 SEPTAVIH"},"study_authorization":{"agency":[{"name":"CPP"},{"name":"Autre"}]},"authoring_entity":[{"name":"Laurence;SLAMA","firstname":"Laurence","lastname":"SLAMA","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"laurence.meyer@aphp.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"","isContact":true},{"name":"Hubert;BLAIN","firstname":"Hubert","lastname":"BLAIN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00mthsf17","role":"organisation id"},{"title":"SIREN","uri":"263400160","role":"organisation id"}],"email":"h-blain@chu-montpellier.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER 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(INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]},{"name":"Mariem;RAHO-MOUSSA","lastname":"RAHO-MOUSSA","firstname":"Mariem","type":"contact","email":"mariem.raho@clin4all.com","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"}]}]},"study_info":{"keywords":[{"keyword":"Infection par le VIH"},{"keyword":"fragilit\u00e9"},{"keyword":"g\u00e9riatrie"}],"topics":[{"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":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"M\u00e9decine interne","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/0d45044a-74d5-4bd7-b920-b92af3388576"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f0844378-9f30-4873-b19b-5bff8c184a36"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D007388"}]},{"topic":"Maladie par le virus de l'immunod\u00e9ficience humaine sans mention de tuberculose ni de paludisme","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1508081745","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Evaluer la pr\u00e9valence de la fragilit\u00e9 selon les crit\u00e8res de Fried chez des personnes vivant avec le VIH de 70 ans et plus. Objectifs secondaires : Etudier et d\u00e9crire la fragilit\u00e9 chez des PVVIH \u00e2g\u00e9es de 70 ans et plus selon les diff\u00e9rents index : Fried, Index de d\u00e9ficits cumul\u00e9s, score HAS, VACS index Etudier l'association entre fragilit\u00e9 et diff\u00e9rents param\u00e8tres sp\u00e9cifiques de l'infection VIH et d'autres param\u00e8tres non sp\u00e9cifiques Identifier les facteurs associ\u00e9s \u00e0 la fragilit\u00e9 \u00e0 M0 et \u00e0 l'\u00e9volution ou la r\u00e9gression de la fragilit\u00e9 durant les 12 mois de suivi Etudier la survenue d'\u00e9bv\u00e8nements p\u00e9joratifs de sant\u00e9 dans les 12 mois de suivi (chutes, passages aux urgences, hospitalisations, institutionnalisation, perte d'un point d'iADL, d\u00e9c\u00e8s) Eva:luer la pr\u00e9valence de la sarcop\u00e9nie et de l'ost\u00e9oporose D\u00e9crire la population (caract\u00e9ristiques socio-d\u00e9mographiques, niveau socio-\u00e9conomique, historique infection VIH et traitements, comorbidit\u00e9s, polym\u00e9dication, sant\u00e9 mentale, qualit\u00e9 de vie, etc) Etudier les marqueurs inflammatoires et d'immuno-s\u00e9nescence \u00e0 M0","abstract":"","coll_dates":[{"start":"2019-01-01","end":"2021-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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\": \"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\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Principaux crit\u00e8res d'inclusion :  - Age >= 70 ans - infection par le VIH-1 - traitement antir\u00e9troviral depuis au moins 12 mois  \",\n    \"clusion_E\": \"toujours en cours lors de l'inclusion  - personne sous protection juridique ou priv\u00e9e de libert\u00e9 - infection isol\u00e9e par le VIH-2 - pronostic vital <6mois D\u00e9but des inclusions = 15\\\/05\\\/20219  Fin des inclusions = 24\\\/01\\\/2020\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"['ATC m\u00e9dicaments , CIM10 cause de d\u00e9c\u00e8s']","committee":"","governance":""}],"other_quality_statement":"['monitorage bas\u00e9 sur les risques (sur site et \u00e0 distance), proc\u00e9dures de datamanagement planifi\u00e9']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation 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 des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"512"},"method_notes":"Etude observationnelle","study_class":"Inconnu","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,"status":"imported","creationDate":"----","lastUpdatedAuto":null,"lastUpdatedManual":"29-10-2020","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industrie","Industrie","Industrie"],"otherFundingAgentType":["","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"prospectif","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"16 centres participants en France : M\u00e9decine Interne H\u00f4p de Bic\u00eatre APHP, M\u00e9decine Interne Antoine B\u00e9cl\u00e8re APHP, Immunologie Clinique H\u00f4tel Dieu APHP, Maladies Infectieuses Piti\u00e9 Salp\u00e9tri\u00e8re APHP, Maladies Infectieuses CHU de Martinique, HDJ Infectiologie H\u00f4p St Andr\u00e9 Bordeaux, Maladies Infectieuses H\u00f4p Pellegrin Bordeaux, Maladies Infectieuses CHU de Montpellier, Infectiologie CHU de Nantes, Infectiologie CHU de Nice , Maladies Infectieuses CHU Pontchaillou Rennes, Centre de soins VIH CHU de Strasbourg, Maladies Infectieuses CHU de Grenoble Alpes, Centre de Diagnostic et de Th\u00e9rapeutique H\u00f4tel Dieu Paris AP-HP"},"dataTypes":{"clinicalDataDetails":"Historique Infection VIH\/ SIDA et traitements antir\u00e9troviraux, Ant\u00e9c\u00e9dents m\u00e9dicaux, comorbidit\u00e9s, traitements concomittents, biom\u00e9trie, evaluation g\u00e9riatrique simplifi\u00e9e M0 et M12 : tests physiques (SPPB, TUG, \u00e9quilibre unipodal, force de pr\u00e9hension), test cognitif (MoCA), ADL, iADL, score de fragilit\u00e9 HAS, index VACS. Recueil des \u00e9v\u00e8nements de sant\u00e9 \u00e0 toutes les visites : chutes graves, chutes \u00e0 r\u00e9p\u00e9tition, passages aux urgences, hospitalisations non programm\u00e9es, institutionnalisation, perte d'une activit\u00e9 de la vie quotidienne, d\u00e9c\u00e8s","biologicalDataDetails":"Bilan Immuno-virologique, h\u00e9matologique, biochimique et m\u00e9tabolique","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}