{"doc_desc":{"title":"Suivi d\u2019une cohorte de sujets pr\u00e9sentant une addiction comportementale et d\u00e9butant des soins dans le service d\u2019Addictologie du CHU de Nantes","idno":"FRESH-PEF73239-fr","producers":[{"name":"Marie GRALL-BRONNEC","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73239-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73239"},{"agency":"FReSH","code":"FRESH-PEF73239"}]},"title":"Suivi d\u2019une cohorte de sujets pr\u00e9sentant une addiction comportementale et d\u00e9butant des soins dans le service d\u2019Addictologie du CHU de Nantes","alternate_title":"EVALADD"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"type":"investigator","name":"Marie;GRALL-BRONNEC","PILabo":"Nantes University Hospital \/ Addiction Treatment and Psychiatry Liaison Department\/Clinical Investigation Unit (CIU) 18 (Nantes University Department): Behavioural Addictions and Complex Mood Disorders; EA 4275 SPHERE: Biostatistics, Pharmacoepidemiology and Subjective Measures in Health Sciences \u2014 Nantes University","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ORCID","uri":"0000-0003-0722-7243","role":"pi id"},{"title":"IdRef","uri":"077685288","role":"pi id"},{"title":"SIREN","uri":"264400136","role":"organisation id"},{"title":"RNSR","uri":"200815512F","role":"labo id"}],"email":"marie.bronnec@chu-nantes.fr","isContact":"Oui"}],"oth_id":[{"name":"EA 4275 SPHERE \"Biostatistique, Pharmaco\u00e9pid\u00e9miologie et Mesures Subjectives en Sant\u00e9\"- universit\u00e9 de Nantes","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"sponsor id"},{"title":"SIREN","uri":"264400136","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Marie;GRALL-BRONNEC","email":"marie.bronnec@chu-nantes.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id","title":"ROR"},{"uri":"264400136","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Addictions comportementales"},{"keyword":"comorbidit\u00e9s psychiatriques"},{"keyword":"personnalit\u00e9"},{"keyword":"impulsivit\u00e9"},{"keyword":"traitement"}],"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\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"}],"purpose":"L\u2019objectif principal est de mieux comprendre les d\u00e9terminants des addictions (facteurs de risque impliqu\u00e9s dans l\u2019initiation du trouble, facteurs pronostiques li\u00e9s \u00e0 l\u2019\u00e9volution du trouble), et ainsi permettre d\u2019am\u00e9liorer les strat\u00e9gies th\u00e9rapeutiques et les actions de pr\u00e9vention. Ainsi nous avons d\u00e9velopp\u00e9 plusieurs axes de recherche, qui s\u2019appuie sur le concept de \u00ab Patient-Centered Outcomes Research \u00bb, pla\u00e7ant le patient \u00e0 chaque \u00e9tape du processus de recherche et qui s\u2019applique particuli\u00e8rement \u00e0 notre domaine d\u2019activit\u00e9 (pr\u00e9f\u00e9rences du patient, qualit\u00e9 de vie, etc.) :","abstract":"","coll_dates":[{"start":"2008-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Pays de la Loire']","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\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"La population concern\u00e9e par la cohorte est compos\u00e9e de patients affili\u00e9s \u00e0 la s\u00e9curit\u00e9 sociale, \u00e2g\u00e9s de 16 ans ou plus, et d\u00e9butant des soins dans le service d\u2019Addictologie et de Psychiatrie de Liaison du CHU de Nantes pour une addiction comportementale. Les patients doivent pr\u00e9senter les crit\u00e8res diagnostiques d\u2019une des addictions comportementales \u00e9tudi\u00e9es et donner leur consentement \u00e9clair\u00e9 pour \u00eatre inclus dans la cohorte. Pour les mineurs et les majeurs prot\u00e9g\u00e9s, le\\\/les repr\u00e9sentant(s) l\u00e9gaux (parents, curateur, etc.) doivent \u00e9galement donner leur consentement. Les patients pr\u00e9sentant des troubles des fonctions sup\u00e9rieures ou des difficult\u00e9s pour la lecture ou l'\u00e9criture de la langue fran\u00e7aise, ainsi que les patients sous tutelle ne sont pas inclus dans 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":"['Le bon remplissage des autoquestionnaires est v\u00e9rifi\u00e9 par l\\'\u00e9valuateur au cours de l\\'\u00e9valuation en face \u00e0 face- La saisie des autoquestionnaires et des h\u00e9t\u00e9roquestionnaires est effectu\u00e9e sur un e-CRF par une secr\u00e9taire. Des tests de coh\u00e9rences sont mis en place dans le e-CRF et une v\u00e9rification de la saisie est effectu\u00e9 sur 10% des dossiers saisis.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\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 des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1440"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques \u00e0 d\u00e9terminer. Utilisation non possible des donn\u00e9es par des industriels.","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":"05-10-2015","lastUpdatedAuto":null,"lastUpdatedManual":"22-10-2018","isContributorPI":"Non","contributorName":"Marie GRALL-BRONNEC","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"Site de l'EA SPHERE qui r\u00e9pertorie l'ensemble des publications des membres de l'EA","link":"http:\/\/je.anaqol.org\/index.php?file=editonecontrat.php"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Non"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Autoquestionnaires papiers compl\u00e9t\u00e9s par les patients pr\u00e9alablement \u00e0 l'entretien en face \u00e0 face- H\u00e9t\u00e9roquestionnaires papiers compl\u00e9t\u00e9s en direct au cours de l'entretien en face \u00e0 face.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Patients en provenance de Nantes et r\u00e9gion Pays de la Loire principalement"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}