{"doc_desc":{"title":"Prospective Follow-Up of Population with Parkinson's Disease - COPARK Cohort","idno":"FRESH-PEF60119-en","producers":[{"name":"Olivier RASCOL","affiliation":"UNIVERSITE DE TOULOUSE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60119-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60119"},{"agency":"FReSH","code":"FRESH-PEF60119"}]},"title":"Prospective Follow-Up of Population with Parkinson's Disease - COPARK Cohort","alternate_title":"COPARK"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Olivier;RASCOL","PILabo":"","affiliationName":"UNIVERSITE DE TOULOUSE","extlink":[{"title":"ORCID","uri":"0000-0002-1410-6397","role":"pi id"},{"title":"IdRef","uri":"084129980","role":"pi id"},{"title":"SIREN","uri":"938271392","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"rascol@cict.fr","isContact":"Yes"}],"oth_id":[{"name":"","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"LN PHARMA","extlink":[{"title":"SIREN","uri":"439632241","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109"},{"title":"SIREN","uri":"263100125"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"LN PHARMA","extlink":[{"title":"SIREN","uri":"439632241"}]},{"name":"ASSOCIATION DE MALADES","extlink":[]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Olivier;RASCOL","email":"rascol@cict.fr","type":"contact","affiliationName":"UNIVERSITE DE TOULOUSE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01ahyrz84","role":"organisation id","title":"ROR"},{"uri":"938271392","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Parkinson's symptoms"},{"keyword":"activities"},{"keyword":"daily life"},{"keyword":"Health episodes"},{"keyword":"quality of life"},{"keyword":"treatment"},{"keyword":"mortality"}],"topics":[{"topic":"Neurology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"General objective: The objective of this multi-disciplinary project (neurology, pharmacology, epidemiology etc.) is to prospectively gather data in a population of outpatients with Parkinson's disease identified through a regional network of hospital neurologists and independent physicians, concerning the onset and progression of motor signs (tremor, akinesia, rigidity, motor complications, freezing, falls, dysarthria ...) and non-motor signs (pain, anxiety and depressive symptoms, autonomic dysfunction, sleep disorders, dementia, apathy, fatigue ...) of PD using validated scales. We will also gather data on quality of life, treatment (care sought and consumption of medication), morbidity and mortality within the same population. Secondary objective: To develop a biobank in the second phase based on phenotypic and pharmacological characterisations outlined in the COPARK population","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2013-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Nouvelle-Aquitaine','Occitanie','Hauts-de-France','Pays de la Loire']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Parkinson's patients with idiopathic Parkinson's disease (UKPDBB criteria) Over 18 years of age, non-institutionalised, with no atypical Parkinsonian syndrome, having never undergone neurosurgery, with no cognitive impairment (MMSE <24), with no serious life-threatening pathology, who have given signed informed consent.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical 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"}]},"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.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"467"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Data may be used by academic teams. Data may be used by industrial teams","conditions":"Data access for research members and non-members under contract approved by the cohort Scientific Committee and according to the terms governing the charter between different partners.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"13-08-2014","isContributorPI":"No","contributorName":"Olivier RASCOL","contributorAffiliation":"UNIVERSITE DE TOULOUSE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"List of publications in Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=%28copark+AND+Rascol+O[Author]%29+OR+24839938[uid]"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Industry","Private non-profit","Industry"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Self-administered questionnaire: Entry from a paper questionnaire (Manual input) with double data entry Interview: Entry from paper questionnaire (manual input) with double data entry Clinical Examinations: Handwritten (Manual input) and double data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"4 REGIONS THROUGHOUT FRANCE (MIDI-PYRENEES, AQUITAINE, PAYS DE LOIRE, NORD PAS DE CALAIS)"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}