{"doc_desc":{"title":"\u00c9tude longitudinale sur la relation entre craving et temps de r\u00e9action dans la d\u00e9sintoxication \u00e0 l'alcool. : utilisation de l\u2019Evaluation Ecologique Momentan\u00e9e","idno":"FRESH-PEF4508-fr","producers":[{"name":"Bruno FALISSARD","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF4508-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"4508"},{"agency":"FReSH","code":"FRESH-PEF4508"}]},"title":"\u00c9tude longitudinale sur la relation entre craving et temps de r\u00e9action dans la d\u00e9sintoxication \u00e0 l'alcool. : utilisation de l\u2019Evaluation Ecologique Momentan\u00e9e","alternate_title":"EMA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Michael;LUKASIEWICZ","firstname":"Michael","lastname":"LUKASIEWICZ","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"michael.lukasiewicz@roche.com","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"Hopital Paul Brousse","isContact":true},{"name":"Bruno;FALISSARD","firstname":"Bruno","lastname":"FALISSARD","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"bruno.falissard@universite-paris-saclay.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"Inserm \/ Inserm U1018 - Centre de Recherche en \u00c9pid\u00e9miologie et Sant\u00e9 des Populations \u00c9quipe: Genre, Sant\u00e9 sexuelle et Reproductive","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":""}]},"distribution_statement":{"contact":[{"name":"Michael;LUKASIEWICZ","lastname":"LUKASIEWICZ","firstname":"Michael","type":"contact","email":"michael.lukasiewicz@roche.com","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":"Bruno;FALISSARD","lastname":"FALISSARD","firstname":"Bruno","type":"contact","email":"bruno.falissard@universite-paris-saclay.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":"d\u00e9sintoxication"},{"keyword":"temps de r\u00e9action"},{"keyword":"Evaluation Ecologique Momentan\u00e9e (EMA)"},{"keyword":"craving"},{"keyword":"enregistrement donn\u00e9es"},{"keyword":"addiction"},{"keyword":"alcool"},{"keyword":"\u00e9valuation"},{"keyword":"difficult\u00e9s"}],"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":"Addictologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/42d645e0-f58d-40ed-9917-5b227ff41a92"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000073316"}]},{"topic":"D\u00e9pendance \u00e0 l'alcool","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1580466198","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Utiliser l'EMA (Evaluation Ecologique Momentan\u00e9e) pour tester la relation entre le temps de r\u00e9action et le craving pendant la d\u00e9sintoxication alcoolique. D\u00e9crire l'intensit\u00e9, la fr\u00e9quence et les facteurs pr\u00e9dictifs de craving, avec un enregistrement simultan\u00e9 d'autres \u00e9tats affectifs.","abstract":"","coll_dates":[{"start":"2005-01-01","end":"2005-12-31"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"D\u00e9pendance \u00e0 l'alcool (\u00e9valuation DSM-IV), hospitalisation pour d\u00e9sintoxication \u00e0 l'alcool, \u00e2ge compris entre 18 et 65 ans. \",\n    \"clusion_E\": \"autres abus de substances (\u00e0 l'exception du tabac), diagnostic psychiatrique ou  handicaps physiques incompatibles avec l'utilisation \\\/ compr\u00e9hension de l'EMA, et l'absence de consentement verbal\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\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&#x27;exercice lib\u00e9ral']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Recording\",\"vocab\":\"CESSDA\"},\"value\":\"Enregistrement (audio, vid\u00e9o, \u00e9lectrophysiologique, imagerie)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"14 patients (n = 1767 mesures\/mesurements)"},"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":"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":"19-10-2012","lastUpdatedAuto":null,"lastUpdatedManual":"11-09-2017","isContributorPI":false,"contributorName":"Bruno FALISSARD","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/16385183"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"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":"Cette proc\u00e9dure comporte l\u2019utilisation d\u2019un ordinateur que les participants emportent avec eux et dans lequel ils peuvent enregistrer le craving soit au moment m\u00eame o\u00f9 il survient soit imm\u00e9diatement apr\u00e8s. Ils y enregistrent leurs \u00e9motions, leurs sensations, les pens\u00e9es concomitantes au moment pr\u00e9cis o\u00f9 survient le craving. Les enregistrement se font 8 \u00e0 12 fois par jour durant les 3 semaines suivant la d\u00e9sintoxication.Un technicien vient r\u00e9cup\u00e9rer les donn\u00e9es une fois par semaine au domicile du patient. De plus, il v\u00e9rifie la batterie de l'appareil d'enregistrement.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Consultation hebdomadaire par un m\u00e9decin senior (Paris)"},"dataTypes":{"clinicalDataDetails":"\u00e9tat clinique, le diagnostic psychiatrique et somatique, ant\u00e9c\u00e9dents d'alcoolisme avec le nombre de processus pass\u00e9s de d\u00e9sintoxication, la consommation de tabac, traitement. \u00c9valuation du craving (Obsessive Craving Drinking Scale), de la d\u00e9pression et de l'anxi\u00e9t\u00e9 (Beck Depression Inventory and Symptom Check list)","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"}