{"doc_desc":{"title":"Organisation of respiratory rehabilitation in post-COVID-19 patients with sequelae. Evaluation and therapeutic indication for remote rehabilitation vs. conventional rehabilitation.","idno":"FRESH-PEF73830-en","producers":[{"name":"","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73830-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73830"},{"agency":"FReSH","code":"FRESH-PEF73830"}]},"title":"Organisation of respiratory rehabilitation in post-COVID-19 patients with sequelae. Evaluation and therapeutic indication for remote rehabilitation vs. conventional rehabilitation.","alternate_title":"REHABCOVID"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Jean-Marc;VALLIER","PILabo":"","affiliationName":null,"extlink":[{"title":"ORCID","uri":"0000-0001-7187-2576","role":"pi id"},{"title":"IdRef","uri":"070464502","role":"pi id"},{"title":"","uri":"","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"vallier@univ-tln.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER INTERCOMMUNAL TOULON \/ LA SEYNE-SUR-MER","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04wqvjr21","role":"sponsor id"},{"title":"SIREN","uri":"268300126","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Jean-Marc;VALLIER","email":"vallier@univ-tln.fr","type":"contact","affiliationName":null,"contactPointLabo":"","extlink":[]}]},"study_info":{"keywords":[],"topics":[{"topic":"Pulmonary medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D015272"}]},{"topic":"Diseases of the respiratory system","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/197934298","title":"CIM-11"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"Compare the efficacy of two respiratory rehabilitation methods on patient physical capacity: a 4-week remote respiratory rehabilitation (RRR) programme vs. a conventional respiratory rehabilitation (RR) programme, for reducing sequelae present in post-COVID-19 patients.","abstract":"","coll_dates":[{"start":"","end":""}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Provence - Alpes - C\u00f4te d\\'Azur']","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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\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\": \"1. Subjects aged over 18\u00a0years. 2. Subjects having contracted COVID-19 determined by a positive RT-PCR test and\\\/or presence of antibodies. 3. Subjects having received a medical prescription for respiratory rehabilitation. 4. Subjects equipped with the necessary computer equipment and network coverage for videoconferencing. 5. Subjects with at least one of the following post-COVID-19 sequelae: - Dyspnoea at rest or on exertion measured using the mMRC (modified Medical Research Council) scale, with a score greater than or equal to 2. (Vestbo et al., 2013) - Hyperventilation measured using the Nijmegen questionnaire, with a score greater than or equal to 23\\\/64 (Van\u00a0Dixhoorn and Duivenvoorden, 1985; Sauty and Prosper, 2008) - Exercise intolerance measured using the 1\u00a0min-STS (1-minute sit-to-stand test) according to the standards based on age and gender, established by Strassmann et al. (2013). - Abnormal fatigue measured using the MFI-20 (Multidimensional Fatigue Inventory), French-language version validated by Gentile et al. (2003) according to the standards based on age and gender, established by Schwarz et al. (2003). - Anxiety and depression status measured using the HADS (Hospital Anxiety and Depression scale), French-language version validated by Roberge et al. (2013) according to the standards based on age and gender, established by Boc\u00e9r\u00e9an and Ducret (2014) 6. Registered with or a beneficiary of a social security scheme.\",\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":[]},"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":"118 subjects (59 patients in the RR group and 59 patients in the RRR group)"},"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\":[]}"},"dataset_use":{"restrictions":"","conditions":"","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":"27-11-2020","lastUpdatedAuto":null,"lastUpdatedManual":"23-04-2021","isContributorPI":"No","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"","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":"No"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}