{"doc_desc":{"title":"Etude longitudinale sur la \"D\u00e9pression, anxi\u00e9t\u00e9 et handicap\" : suivi de sujets en m\u00e9decine g\u00e9n\u00e9rale","idno":"FRESH-PEF178-fr","producers":[{"name":"Christine TRUCHI","affiliation":"LUNDBECK SAS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF178-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"178"},{"agency":"FReSH","code":"FRESH-PEF178"}]},"title":"Etude longitudinale sur la \"D\u00e9pression, anxi\u00e9t\u00e9 et handicap\" : suivi de sujets en m\u00e9decine g\u00e9n\u00e9rale","alternate_title":"D\u00e9PasS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Anne;CROCHARD","firstname":"Anne","lastname":"CROCHARD","type":"investigator","extlink":[{"title":"SIREN","uri":"552123200","role":"organisation id"}],"email":"","affiliationName":"LUNDBECK SAS","PILabo":"Lundbeck","isContact":false}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"LUNDBECK SAS","extlink":[{"title":"SIREN","uri":"552123200","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"LUNDBECK SAS","extlink":[{"title":"SIREN","uri":"552123200"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"troubles anxieux"},{"keyword":"Sheehan"},{"keyword":"d\u00e9pression"},{"keyword":"retentissement fonctionnel"},{"keyword":"m\u00e9decine g\u00e9n\u00e9rale"},{"keyword":"antid\u00e9presseur"}],"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":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Evaluer l\u2019\u00e9volution \u00e0 3 mois du niveau de Handicap personnel, professionnel et social par l\u2019\u00e9chelle de Sheehan, des patients pr\u00e9sentant l\u2019une des cinq pathologies psychiatriques suivantes : \u00e9pisode d\u00e9pressif majeur c'est-\u00e0-dire caract\u00e9ris\u00e9, trouble anxi\u00e9t\u00e9 g\u00e9n\u00e9ralis\u00e9e, trouble anxi\u00e9t\u00e9 sociale, trouble panique avec ou sans agoraphobie et troubles obsessionnels compulsifs, et pour laquelle un nouveau traitement par antid\u00e9presseur vient d\u2019\u00eatre initi\u00e9.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2010-01-01"}],"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\": \"Patient \u00e2g\u00e9 d\u2019au moins 18 ans Patient pr\u00e9sentant au moins l\u2019un des 5 diagnostics suivants :      Episode d\u00e9pressifmajeur (c'est-\u00e0-dire caract\u00e9ris\u00e9)      Trouble anxi\u00e9t\u00e9 g\u00e9n\u00e9ralis\u00e9e      Trouble anxi\u00e9t\u00e9 sociale      Trouble panique avec ou sans agoraphobie      Troubles obsessionnels compulsifs Patient initiant un nouveau traitement par antid\u00e9presseur Patient en \u00e9tat de communiquer et d\u2019\u00e9valuer sa qualit\u00e9 de vie Patient ayant re\u00e7u une information \u00e9crite sur l\u2019utilisation de donn\u00e9es m\u00e9dicales le concernant dans le cadre de l\u2019\u00e9tude.\",\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\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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'exercice lib\u00e9ral']"}},"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":"[1000-10000[ individus","response_rate":"8 029"},"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":"","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":"16-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":false,"contributorName":"Christine TRUCHI","contributorAffiliation":"LUNDBECK SAS","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/Hal-DEPASS"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Le recueil des donn\u00e9es sera r\u00e9alis\u00e9 lors de chaque visite de fa\u00e7on volontaire et anonyme.Les donn\u00e9es seront recueillies au cours des visites habituelles du patient : au moment de la visite d\u2019inclusion,\u00e0 environ 6 semaines puis 3 mois apr\u00e8s cette visite. Les visites ne sont pas impos\u00e9es, elles correspondent \u00e0 des visites effectu\u00e9es en routine.La mesure du handicap sera effectu\u00e9e \u00e0 chaque visite par le biais de l\u2019auto-questionnaire de Sheehan aupr\u00e8sdu patient.La symptomatologie du patient est \u00e9galement renseign\u00e9e par le patient lui-m\u00eame au moyen de l\u2019autoquestionnaire HAD \u00e0 chacun des trois temps de recueil pr\u00e9vus dans l\u2019\u00e9tude.Les autres donn\u00e9es sont renseign\u00e9es par le m\u00e9decin lui-m\u00eame.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","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"}