{"doc_desc":{"title":"Etude longitudinale sur des patients atteints de polyarthrite rhumato\u00efde ou de purpura thrombocytop\u00e9nique : \u00e9valuation de l'outil Sanoia (dossiers de sant\u00e9 \u00e9lectroniques)","idno":"FRESH-PEF5201-fr","producers":[{"name":"Laurent CHICHE","affiliation":"HOPITAL EUROPEEN MARSEILLE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5201-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5201"},{"agency":"FReSH","code":"FRESH-PEF5201"}]},"title":"Etude longitudinale sur des patients atteints de polyarthrite rhumato\u00efde ou de purpura thrombocytop\u00e9nique : \u00e9valuation de l'outil Sanoia (dossiers de sant\u00e9 \u00e9lectroniques)","alternate_title":"SANOIA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Adam;SELAMNIA","firstname":"Adam","lastname":"SELAMNIA","type":"investigator","extlink":[{"title":"","uri":"","role":"organisation id"}],"email":"mselamnia@sanoia.com","affiliationName":"AIMSU - ASSOCIATION POUR L'INFORMATION MEDICALE EN SITUATIONS D'URGENCES","PILabo":"AIMSU - Association pour l'Information M\u00e9dicale en Situations d'Urgences -","isContact":true},{"name":"Herv\u00e9;SERVY","firstname":"Herv\u00e9","lastname":"SERVY","type":"investigator","extlink":[{"title":"","uri":"","role":"organisation id"}],"email":"hservy@sanoia.com","affiliationName":"AIMSU - ASSOCIATION POUR L'INFORMATION MEDICALE EN SITUATIONS D'URGENCES","PILabo":"AIMSU - Association pour l'Information M\u00e9dicale en Situations d'Urgences -","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"E-HEALTH SERVICES SANOIA","extlink":[{"title":"SIREN","uri":"528233190","role":"sponsor id"}],"role":"sponsor"},{"name":"","role":"sponsor"}],"funding_agencies":[{"name":"AMGEN","extlink":[{"title":"SIREN","uri":"377998679"}]},{"name":"CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE (CNRS)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02feahw73"},{"title":"SIREN","uri":"180089013"}]},{"name":"UCB PHARMA (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01n6t9x28"},{"title":"SIREN","uri":"562079046"}]}]},"distribution_statement":{"contact":[{"name":"Adam;SELAMNIA","lastname":"SELAMNIA","firstname":"Adam","type":"contact","email":"mselamnia@sanoia.com","affiliationName":"AIMSU - ASSOCIATION POUR L'INFORMATION MEDICALE EN SITUATIONS D'URGENCES","contactPointLabo":"","extlink":[]},{"name":"Herv\u00e9;SERVY","lastname":"SERVY","firstname":"Herv\u00e9","type":"contact","email":"hservy@sanoia.com","affiliationName":"AIMSU - ASSOCIATION POUR L'INFORMATION MEDICALE EN SITUATIONS D'URGENCES","contactPointLabo":"","extlink":[]}]},"study_info":{"keywords":[{"keyword":"rhumatologie"},{"keyword":"\u00e9v\u00e8nements rapport\u00e9s par le patient (PRO)"},{"keyword":"traitements"},{"keyword":"score RAID"},{"keyword":"score RAPID-3"},{"keyword":"qualit\u00e9 de vie"},{"keyword":"donn\u00e9es de sant\u00e9 \u00e9lectroniques"}],"topics":[{"topic":"H\u00e9matologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006402"}]},{"topic":"Rhumatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D012219"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"La Soci\u00e9t\u00e9 Fran\u00e7aise de Rhumatologie (SFR) et l\u2019association de patients ANDAR ont \u00e9tabli un partenariat depuis d\u00e9but 2012, visant \u00e0 diffuser un nouvel outil (Sanoia) permettant aux patients de noter et suivre leurs donn\u00e9es personnelles contribuant \u00e0 leur suivi. Cet outil comporte un attendu important en termes d\u2019\u00e9pid\u00e9miologie. En effet les informations saisies anonymement par le patient, quant \u00e0 sa situation m\u00e9dicale et le ressenti de la maladie, sont agr\u00e9geables pour la recherche. L'outil apr\u00e8s une phase d'\u00e9valuation, est actuellement d\u00e9ploy\u00e9 sur deux pathologies: Enqu\u00eate 1: Evaluer la faisabilit\u00e9 et l'adoption de SANOIA, un dossier de sant\u00e9 personnel librement accessible, pour les patients atteints de polyarthrite rhumato\u00efde. A d\u00e9cembre 2012, ce sont 2902 patients qui l'avaient adopt\u00e9. Enqu\u00eate 2: Evaluer la faisabilit\u00e9 et l'adoption de SANOIA, un carnet de sant\u00e9 personnel librement accessible, qui a \u00e9t\u00e9 adapt\u00e9 pour les patients atteints d'une maladie rare: le purpura thrombocytop\u00e9nique.\"","abstract":"","coll_dates":[{"start":"2010-01-01"}],"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\": \"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            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients avec une polyarthrite rhumatoide, adultes remplissant les crit\u00e8res ACR de classification (1987, American College of Rheumatology) ayant un acc\u00e8s internet (Enqu\u00eate 1) Patients \u00e2g\u00e9s entre 18 et 75 ans, avec un diagnostic de purpura thrombocytop\u00e9nique chronique selon les directives internationales, avec acc\u00e8s permanent au Web, et sans probl\u00e8me psychiatrique (Enqu\u00eate 2)\",\n    \"clusion_E\": \"\"\n}","data_kind":"['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\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\":\"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":"n = 56 for RA Patients. Extended to 2,902 patients in December 2012n = 72 for ITP Patients"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"Ouvert \u00e0 tout organisme de Recherche, priv\u00e9 ou publique, mais soumis \u00e0 instruction pour avis \u00e9thique aupr\u00e8s de la Soci\u00e9t\u00e9 Fran\u00e7aise de Rhumatologie.","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":"21-12-2012","lastUpdatedAuto":null,"lastUpdatedManual":"08-02-2013","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"List of publications in Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=%28Servy+H[author]+OR+Selamnia+A[author]%29+AND+SANOIA"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie","Public (France)","Industrie"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Industrie","Priv\u00e9 \u00e0 but non lucratif"],"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":"Enqu\u00eate 1: Le contenu de la fiche Sanoia des patients de l'\u00e9tude -remplie par leurs soins avec une assistance variable selon le groupe d'affectation- a \u00e9t\u00e9 confront\u00e9 \u00e0 3 mois au contenu de leur dossier m\u00e9dical -d\u00e9tenu par leur m\u00e9decin rhumatologue- selon l'exhaustivit\u00e9 des informations relatives aux traitements, aux commorbidit\u00e9s et aux ant\u00e9c\u00e9dents.Enqu\u00eate 2: Les donn\u00e9es d\u00e9mographiques et m\u00e9dicales, ainsi que l'\u00e9valuation de la qualit\u00e9 de vie li\u00e9e \u00e0 la sant\u00e9 en utilisant le dossier \u00e9lectronique Sanoia ont \u00e9t\u00e9 \u00e9valu\u00e9s \u00e0 l'inclusion et \u00e0 1, 3 et 6 mois par courrier postal. L'utilisation du dossier Sanoia a \u00e9t\u00e9 \u00e9valu\u00e9e par un questionnaire sp\u00e9cifique et en mesurant la fr\u00e9quence des connexions de chaque patient.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","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"}