{"doc_desc":{"title":"Etude transversale sur des patients diab\u00e9tiques de type 2 ob\u00e8ses : \u00e9laboration d'un score clinique pr\u00e9dictif de l'adh\u00e9sion aux modifications de leur prise en charge th\u00e9rapeutique et de leur hygi\u00e8ne de vie","idno":"FRESH-PEF91-fr","producers":[{"name":"Franck VIGNAL","affiliation":"SANOFI (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF91-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"91"},{"agency":"FReSH","code":"FRESH-PEF91"}]},"title":"Etude transversale sur des patients diab\u00e9tiques de type 2 ob\u00e8ses : \u00e9laboration d'un score clinique pr\u00e9dictif de l'adh\u00e9sion aux modifications de leur prise en charge th\u00e9rapeutique et de leur hygi\u00e8ne de vie","alternate_title":"MELODIE"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Franck;VIGNAL","PILabo":"Sanofi Aventis","affiliationName":"SANOFI (FRANCE)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"395030844","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"franck.vignal@sanofi.com","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"SANOFI (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837","role":"sponsor id"},{"title":"SIREN","uri":"395030844","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837"},{"title":"SIREN","uri":"395030844"}]}]},"distribution_statement":{"contact":[{"name":"Franck;VIGNAL","email":"franck.vignal@sanofi.com","type":"contact","affiliationName":"SANOFI (FRANCE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02n6c9837","role":"organisation id","title":"ROR"},{"uri":"395030844","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"score pr\u00e9dictif"},{"keyword":"adh\u00e9sion aux modifications de prise en charge th\u00e9rapeutique de leur hygi\u00e8ne de vie"}],"topics":[{"topic":"Endocrinologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"Diab\u00e8te sucr\u00e9 de type 2","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/119724091","title":"CIM-11"}]},{"topic":"Ob\u00e9sit\u00e9","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/149403041","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"A partir des facteurs de risque cardiovasculaire des patients ob\u00e8ses diab\u00e9tiques de type 2 non \u00e9quilibr\u00e9s, \u00e9laborer un score clinique pr\u00e9dictif de l\u2019adh\u00e9sion des patients aux modifications de leur prise en charge th\u00e9rapeutique et\/ou de leur hygi\u00e8ne de vie qui leur sont prescrites","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2008-12-31"}],"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Homme ou femme \u00e2g\u00e9(e) de plus de 18 ans ; Diab\u00e9tique de type 2 trait\u00e9 par monoth\u00e9rapie antidiab\u00e9tique orale ; HbA1c sup ou \u00e9gale \u00e0 6,5 %; IMC sup ou \u00e9gale \u00e0 30 kg\\\/m2; ob\u00e9sit\u00e9 abdominale d\u00e9finie selon les crit\u00e8res NCEP \\\/ ATPIII \u2013 2001 : p\u00e9rim\u00e8tre abdominal sup \u00e0 88 cm pour les femmes et 102 cm pour les hommes.\",\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"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}","{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"5040"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"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":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2018","isContributorPI":"Non","contributorName":"Franck VIGNAL","contributorAffiliation":"SANOFI 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