{"doc_desc":{"title":"Longitudinal study of schizophrenic patients: factors influencing social autonomy","idno":"FRESH-PEF73225-en","producers":[{"name":"Isabelle GASQUET","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73225-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73225"},{"agency":"FReSH","code":"FRESH-PEF73225"}]},"title":"Longitudinal study of schizophrenic patients: factors influencing social autonomy","alternate_title":"ESPASS"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Jean-Michel;AZORIN","PILabo":"H\u00f4pital Sainte-Marguerite AP-HM","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"029037271","role":"pi id"},{"title":"SIREN","uri":"261300081","role":"organisation id"},{"title":"RNSR","uri":"200616357H","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Isabelle;GASQUET","PILabo":"H\u00f4pital Cochin AP-HP \/ INSERM U669","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"072469218","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"RNSR","uri":"200616357H","role":"labo id"}],"email":"isabelle.gasquet@aphp.fr","isContact":"Yes"},{"type":"investigator","name":"Denis;LEGUAY","PILabo":"CE.SA.ME, Angers","affiliationName":"CESAME CTRE DE SANTE MENTALE ANGEVIN","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"074636006","role":"pi id"},{"title":"SIREN","uri":"264900614","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"denis.leguay@free.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229"},{"title":"SIREN","uri":"380059956"}]},{"name":"OTSUKA PHARMACEUTICAL FRANCE SAS","extlink":[{"title":"SIREN","uri":"453720336"}]}]},"distribution_statement":{"contact":[{"name":"Isabelle;GASQUET","email":"isabelle.gasquet@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Denis;LEGUAY","email":"denis.leguay@free.fr","type":"contact","affiliationName":"CESAME CTRE DE SANTE MENTALE ANGEVIN","contactPointLabo":"","extlink":[{"uri":"264900614","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"schizophrenia"},{"keyword":"care"},{"keyword":"social life"},{"keyword":"satisfaction"}],"topics":[{"topic":"Psychiatry","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]},{"topic":"Schizophrenia","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1683919430","title":"CIM-11"}]},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The objective of the ESPASS pharmacoepidemiological study is to evaluate the impact at 6 months of the change or the introduction of the main antipsychotic treatment on the social autonomy of patients with schizophrenia according to the possible pathway to autonomy put in place.","abstract":"","coll_dates":[{"start":"","end":""}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients were required to meet the DSM-IV TR diagnostic criteria for schizophrenia, requiring an initiation of or change in antipsychotic therapy for any reason, they should not meet the criteria of an acute psychotic episode and should not require a normothymic drug\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"6165"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"10-09-2015","lastUpdatedAuto":null,"lastUpdatedManual":"14-09-2017","isContributorPI":"No","contributorName":"Isabelle GASQUET","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.icta.fr\/media\/14094\/ICTA_2008_Poster_ESPASS_n5.pdf"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry","Industry"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}