{"study_desc":{"title_statement":{"idno":"FRESH-PEF90-en","IDno":{"metadata_no":[{"agency":"PEF","code":"90"},{"agency":"FReSH","code":"FRESH-PEF90"}]},"title":"National Observatory on the therapeutic management in general practice of patients aged 65 and over with type 2 diabetes, chronic pain or atrial fibrillation","alternate_title":"Les S.AGES"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"name":"Franck;VIGNAL","firstname":"Franck","lastname":"VIGNAL","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837","role":"organisation id"},{"title":"SIREN","uri":"395030844","role":"organisation id"}],"email":"franck.vignal@sanofi.com","affiliationName":"SANOFI (FRANCE)","PILabo":"Sanofi Aventis","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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\/01kv58h76"},{"title":"SIREN","uri":"180089385"}]}]},"distribution_statement":{"contact":[{"name":"Franck;VIGNAL","lastname":"VIGNAL","firstname":"Franck","type":"contact","email":"franck.vignal@sanofi.com","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":"Elderly subject observatories"}],"topics":[{"topic":"Type 2 diabetes mellitus","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/119724091","title":"CIM-11"}]},{"topic":"Atrial fibrillation","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/171698302","title":"CIM-11"}]},{"topic":"Chronic pain","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1581976053","title":"CIM-11"}]}],"purpose":"Describe the therapeutic care in general practice of patients aged 65 years and older having type-2 diabetes, chronic pain or atrial fibrillation.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2014-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Aged (65 to 79 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Aged, 80 and over (80 years and more)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Patients population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"\u25aa Man or woman ages 65 years and older residing in metropolitan  \u25aa Affiliated with a social security scheme or beneficiary of an equivalent scheme \u2022 Accepting to participate in the study and who have signed the consent form \u25aa Having type-2 diabetes treated by oral diabetes medication and\/or injectable diabetes medication (for the Diabetes observatory) \u25aa Having or who has had in the 12 months preceding inclusion, a documented atrial fibrillation (AF) (by ECG or Holter ECG) regardless of the rhythm on the day of inclusion (for the Atrial Fibrillation observatory) \u25aa Having a pain that has been evolving for more than 3 months, requiring care (for the Chronic Pain observatory)\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Paraclinical data (non-biological)','Paraclinical data (non-biological) : Other','Biological data','Socio-demographic data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)','Through independent healthcare practitioners']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"in progress"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}","notes":""},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"14-12-2010","lastUpdatedManual":"18-01-2013","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industry"],"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":"Collection of data for each of the visits, by the general practitioner, on an internet website devoted to each of the observatories.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"- Creatinine - HBA1C for the Diabetes observation","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}