{"study_desc":{"title_statement":{"idno":"FRESH-PEF74005-en","IDno":{"metadata_no":[{"agency":"PEF","code":"74005"},{"agency":"FReSH","code":"FRESH-PEF74005"}]},"title":"Functional and respiratory rehabilitation and nutritional support for patients with COVID-19","alternate_title":"RECOVER-19"},"study_authorization":{"agency":[{"name":"CPP"},{"name":"ANSM"}]},"authoring_entity":[{"name":"Lilian;ALIX","firstname":"Lilian","lastname":"ALIX","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05qec5a53","role":"organisation id"},{"uri":"160855349","role":"pi id","title":"IdRef"}],"email":"lilian.alix@chu-rennes.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES","PILabo":"","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"Centre Hospitalier Universitaire de Rennes","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05qec5a53","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Lilian;ALIX","lastname":"ALIX","firstname":"Lilian","type":"contact","email":"lilian.alix@chu-rennes.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qec5a53","role":"organisation id","title":"ROR"}]}]},"study_info":{"keywords":[{"keyword":"COVID-19"},{"keyword":"retraining"},{"keyword":"physiotherapy"},{"keyword":"rehabilitation"}],"topics":[{"topic":"Infectious disease medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"D055552"}]},{"topic":"Internal medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/0d45044a-74d5-4bd7-b920-b92af3388576 | http:\/\/data.europa.eu\/8mn\/euroscivoc\/f0844378-9f30-4873-b19b-5bff8c184a36"},{"title":"MeSH","uri":"D007388"}]},{"topic":"Physical and Rehabilitation Medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/38e57437-b2cc-4d26-a46e-c5b639c01e5f"},{"title":"MeSH","uri":"D010810"}]},{"topic":"Pulmonary medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"D015272"}]},{"topic":"Certain infectious or parasitic diseases","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1435254666","title":"CIM-11"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"Determine the efficacy of the individually tailored multidisciplinary healthcare path (including exercise rehabilitation, pulmonary rehabilitation, if necessary, and a nutritional therapeutic strategy) on quality of life (physical component of the SF-36) of patients with COVID-19.","abstract":"","coll_dates":[{"start":"2020-01-01","end":"2021-01-01"}],"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\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"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\":\"Adult patient defined as a confirmed COVID-19 case who may or may not have been admitted to hospital for COVID-19  -Date of onset of the first COVID-19 symptoms \u2265 4\u00a0weeks and < 4\u00a0months  -Patients with functional and\/or respiratory deficiency and\/or asthenia and\/or undernutrition, persisting for more than 4 weeks from the first symptoms of COVID-19: o Increase in the dyspnoea score \u2265 1 as per the mMRC scale from the month prior to COVID-19 and after the first 4 weeks post-COVID-19 and\/or o Asthenia score > 22 according to the Pichot scale after the first 4 weeks post-COVID-19, in the absence of asthenia in the month prior to COVID-19 (asthenia score <8 as per the Pichot scale) and\/or o Reported weight loss > 5% in less than 6 months, comparing the patient\u2019s minimum weight in the month prior to COVID-19 and their weight after the first 4 weeks post-COVID-19 and\/or o Current BMI < 20 (if aged < 70 years) or < 22 (if aged \u2265 70 years) if BMI was \u2265 20 (if aged < 70 years) or \u2265 22 (if aged \u2265 70 years) in the month prior to COVID-19\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Biological data','Socio-demographic data','Economic data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"","sources":[],"target_sample_size":"< 500 individuals","response_rate":"160"},"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":"23-03-2021","lastUpdatedManual":"02-06-2021","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"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":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}