{"doc_desc":{"title":"Etude longitudinale sur des patients atteints de troubles bipolaires","idno":"FRESH-PEF73233-fr","producers":[{"name":"Chantal HENRY","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73233-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73233"},{"agency":"FReSH","code":"FRESH-PEF73233"}]},"title":"Etude longitudinale sur des patients atteints de troubles bipolaires","alternate_title":"FACE-BD"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"name":"Chantal;HENRY","firstname":"Chantal","lastname":"HENRY","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"ch.henry@ghu-paris.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSERM","isContact":true}],"oth_id":[{"name":"La Fondation FondaMental","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"FONDATION FONDAMENTAL","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rrhf939","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"MINISTERE DE L\u2019ENSEIGNEMENT SUPERIEUR, DE LA RECHERCHE ET DE L\u2019ESPACE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03sjk9a61"},{"title":"SIREN","uri":"110044013"}]}]},"distribution_statement":{"contact":[{"name":"Chantal;HENRY","lastname":"HENRY","firstname":"Chantal","type":"contact","email":"ch.henry@ghu-paris.fr","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":"Troubles bipolaires"},{"keyword":"impulsivit\u00e9"},{"keyword":"humeur"},{"keyword":"traitement"},{"keyword":"pratiques cliniques"}],"topics":[{"topic":"Psychiatrie","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":"Troubles bipolaires ou apparent\u00e9s","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/613065957","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Les objectifs sont : \u2022d'acc\u00e9l\u00e9rer l'acc\u00e8s \u00e0 des sp\u00e9cialistes pour tous les cas de troubles bipolaires \u2022 r\u00e9duire les d\u00e9lais entre l'apparition des maladies, un diagnostic pr\u00e9cis et l'introduction d'un traitement appropri\u00e9 \u2022 am\u00e9liorer la concordance entre les directives de m\u00e9decine factuelle et la pratique clinique \u2022 connaissances et comp\u00e9tences sur les nouvelles strat\u00e9gies th\u00e9rapeutiques diffuser \u2022 promouvoir une approche de m\u00e9decine personnalis\u00e9e en : \u25cb \u00e9tudiant la physiopathologie sous-jacente des troubles bipolaires et de ses sous-types \u25cb am\u00e9liorant la d\u00e9tection et la pr\u00e9vention de comorbidit\u00e9 somatique et les troubles psychiatriques \u25cb \u00e9valuant prospectivement l'impact des traitements recommand\u00e9s pour l'individu ainsi que les facteurs de protection et de risque de rechute.","abstract":"","coll_dates":[{"start":"2007-01-01"}],"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    \"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\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients victimes de troubles bipolaires dans un des 8 centres de la Fondation FondaMental\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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":"","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\":\"MeasurementsAndTests.Psychological\",\"vocab\":\"CESSDA\"},\"value\":\"Tests psychologiques\/\u00e9chelles cliniques (d\u00e9pression, cognition, qualit\u00e9 de vie...)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"839"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"Pour les membres du R\u00e9seau FondaMental qui souhaitent acc\u00e9der aux donn\u00e9es de la base FACE, voici la proc\u00e9dure \u00e0 suivre : 1. Remplir une fiche de demande de sommaire et de th\u00e9saurus de la base FACE et l'envoyer \u00e0 face@fondation-fondamental.org. 2. Suite \u00e0 cet envoi, deux documents vous seront transmis: le th\u00e9saurus FACE (liste de toutes les variables disponibles) et le sommaire FACE (Donn\u00e9es class\u00e9es par grandes th\u00e9matiques) sp\u00e9cifiques \u00e0 la pathologie sp\u00e9cifi\u00e9e. 3. Pour faire une demande d'extraction, le dossier complet \u00e0 fournir comprend 3 \u00e9l\u00e9ments qui sont les suivants: - le formulaire de demande d\u2019extraction de donn\u00e9es de la base FACE (compl\u00e9t\u00e9 et sign\u00e9) - la lettre d'engagement (compl\u00e9t\u00e9e et sign\u00e9e) - le th\u00e9saurus (avec les variables demand\u00e9es coch\u00e9es) Ce dossier est \u00e0 envoyer \u00e0 : face@fondation-fondamental.org","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":"29-09-2015","lastUpdatedAuto":null,"lastUpdatedManual":"14-09-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=FACE-BD"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"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":"Evaluation compl\u00e8te est effectu\u00e9e par les membres d'une \u00e9quipe multidisciplinaire sp\u00e9cialis\u00e9e: une infirmi\u00e8re, un psychologue clinique, un neuro-psychologue, un psychiatre et un travailleur social","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Diagnostic (SCID) , symptomes, traitement, \u00e9tats d'humeur actuels et sympt\u00f4mes r\u00e9siduels : d\u00e9pression (MADRS), anxi\u00e9t\u00e9 (STAY-A), fonctionnement et la gravit\u00e9 des troubles (Global Assessment of Functioning scale (GAF), Functioning Assessment Short Test (FAST), Clinical Global Impressions Scale (CGI)), les comorbidit\u00e9s psychiatriques et des traumatismes (SCID, Wender Utah Rating Scale (WURS), Childhood Trauma Questionnaire (CTQ), Suicide Intent Scale (SIS), Risk Rescue Rating Scale, Measure of suicidal Ideation (ISF)), les facteurs de risque et de fardeau m\u00e9dical (Fagestrom questionnaire), examination physique, bilan biochimique, trouble du sommeil (Pittsburgh Sleep Quality Index (PSQI) , Epworth Vigilance Scale), \u00e9valuation inter-\u00e9pisode (Affect Intensity Measure (AIM), Affective Lability Scale (ALS) ),","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}