{"doc_desc":{"title":"Etude cas-t\u00e9moins sur l'Education TH\u00e9rapeutique Individuelle et Collective du patient \u00e0 risque CARdiovasculaire en m\u00e9decine g\u00e9n\u00e9rale","idno":"FRESH-PEF8543-fr","producers":[{"name":"Bernard GAY","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8543-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8543"},{"agency":"FReSH","code":"FRESH-PEF8543"}]},"title":"Etude cas-t\u00e9moins sur l'Education TH\u00e9rapeutique Individuelle et Collective du patient \u00e0 risque CARdiovasculaire en m\u00e9decine g\u00e9n\u00e9rale","alternate_title":"ETHICCAR"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"name":"Jean-Louis;DEMEAUX","firstname":"Jean-Louis","lastname":"DEMEAUX","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"organisation id"},{"title":"SIREN","uri":"130018351","role":"organisation id"}],"email":"","affiliationName":"UNIVERSITE DE BORDEAUX","PILabo":"Universit\u00e9 de \/ U 897 - D\u00e9partement de M\u00e9decine G\u00e9n\u00e9rale","isContact":false},{"name":"Bernard;GAY","firstname":"Bernard","lastname":"GAY","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"organisation id"},{"title":"SIREN","uri":"130018351","role":"organisation id"}],"email":"bernard.gay@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","PILabo":"Universit\u00e9 de \/ U 897 - D\u00e9partement de M\u00e9decine G\u00e9n\u00e9rale","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"},{"name":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"sponsor id"},{"title":"SIREN","uri":"130018351","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"HAUTE AUTORITE DE SANTE (HAS)","extlink":[{"title":"SIREN","uri":"110000445"}]},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]},{"name":"GROUPEMENT REGIONAL DE SANTE PUBLIQUE"},{"name":""}]},"distribution_statement":{"contact":[{"name":"Bernard;GAY","lastname":"GAY","firstname":"Bernard","type":"contact","email":"bernard.gay@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"\u00c9ducation th\u00e9rapeutique"},{"keyword":"psychosocial"},{"keyword":"individuel"},{"keyword":"collectif."},{"keyword":"risque cardiovasculaire"},{"keyword":"nutrition"},{"keyword":"alcool"},{"keyword":"tabac"},{"keyword":"activit\u00e9 physique"},{"keyword":"profil"}],"topics":[{"topic":"Cardiologie et m\u00e9decine vasculaire","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D002309"}]},{"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":"Hypertension essentielle","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/761947693","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"\u00c9valuer l\u2019efficacit\u00e9 de l\u2019\u00e9ducation th\u00e9rapeutique sur la r\u00e9duction du risque et\/ou de la morbi-mortalit\u00e9 cardiovasculaires des patients hypertendus, par rapport au suivi habituel. Objectifs secondaires : - D\u00e9crire l\u2019\u00e9volution du score de risque cardiovasculaire sur 5 ans dans les trois groupes\u00a0: \u00e9ducation individuelle, \u00e9ducation collective et groupe t\u00e9moin (suivi habituel) ; - Comparer la morbi-mortalit\u00e9 dans les 3 groupes ; - Comparer l\u2019efficacit\u00e9 de l\u2019intervention individuelle ou de l\u2019intervention collective versus le suivi habituel ; - Comparer les r\u00e9sultats de l\u2019intervention individuelle \u00e0 ceux de l\u2019intervention collective ; - Analyser le profil psychosocial des r\u00e9pondeurs \u00e0 l\u2019une ou l\u2019autre des m\u00e9thodes ; - Rep\u00e9rer les \u00e9l\u00e9ments susceptibles de justifier le choix de l\u2019une ou de l\u2019autre m\u00e9thode ou de leur association ; - D\u00e9crire et comparer la qualit\u00e9 de vie des patients dans les 3 groupes.","abstract":"","coll_dates":[{"start":"2009-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Nouvelle-Aquitaine']","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 (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\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Hommes de plus de 50 ans et femmes de plus de 60 ans (\u00e2ge<75ans) - Pr\u00e9sentant une HTA essentielle (pression systolique \u2265140 mmHg, pression diastolique \u226590 mmHg) - Pr\u00e9sentant un autre facteur de risque\u00a0: tabac, diab\u00e8te, dyslipid\u00e9mie (soit au minimum 3 facteurs de risque cardiovasculaire) - Sans ant\u00e9c\u00e9dent d\u2019accident cardiovasculaire (pr\u00e9vention primaire)  \",\n    \"clusion_E\": \"Ant\u00e9c\u00e9dent d\u2019accident cardiovasculaire - Hypertension art\u00e9rielle secondaire - Diab\u00e8te de type 1 - Pathologie susceptible d\u2019engager le pronostic vital \u00e0 court terme - Situation sociale ou culturelle rendant impossible une d\u00e9marche \u00e9ducative - Impossibilit\u00e9 d\u2019un suivi sur au moins deux ans - Patient inclus dans une autre \u00e9tude susceptible de modifier la prise en charge (\u00e9tude de cohorte, essai th\u00e9rapeutique)\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques']","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\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue\r\nAutres"}]},"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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"188 patients inclus : 66 dans le groupe d'intervention collective, 68 dans le groupe d'intervention individuelle et 54 dans le groupe t\u00e9moin."},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Etude cas-t\u00e9moins"]}]},"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":"01-04-2014","lastUpdatedAuto":null,"lastUpdatedManual":"12-05-2015","isContributorPI":false,"contributorName":"Bernard GAY","contributorAffiliation":"UNIVERSITE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.researchgate.net\/publication\/233842679_Education_thrapeutique_du_patient_en_mdecine_gnrale._Ltude_ETHICCAR__faisabilit_et_valuation_chez_le_patient__risque_cardiovasculaire"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","","",""]},"sponsor":{"sponsorType":["Public (France)","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":"J0, J0 + 6 mois, JO + 12 mois, J0 + 24 mois, JO + 36 mois, J0 + 48 mois, J0 + 60 mois.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Aquitaine"},"dataTypes":{"clinicalDataDetails":"\u00c9v\u00e9nements cardiovasculaires, Indice de Masse Corporelle, \u00e9chocardio.","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"}