{"doc_desc":{"title":"R\u00e9habilitation fonctionnelle et respiratoire et soin nutritionnel des patients atteints de la COVID-19","idno":"FRESH-PEF74005-fr","producers":[{"name":"","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74005-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74005"},{"agency":"FReSH","code":"FRESH-PEF74005"}]},"title":"R\u00e9habilitation fonctionnelle et respiratoire et soin nutritionnel des patients atteints de la COVID-19","alternate_title":"RECOVER-19"},"study_authorization":{"agency":[{"name":"CPP"},{"name":"ANSM"}]},"authoring_entity":[{"type":"investigator","name":"Lilian;ALIX","PILabo":"","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"160855349","role":"pi id"},{"title":"ROR","uri":"https:\/\/ror.org\/05qec5a53","role":"organisation id"},{"title":"","uri":"","role":"labo 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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":"Certaines maladies infectieuses ou parasitaires","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":"D\u00e9terminer l\u2019efficacit\u00e9 d\u2019un parcours de soins multidisciplinaire personnalis\u00e9 (comportant une r\u00e9adaptation \u00e0 l\u2019effort, une r\u00e9habilitation respiratoire si n\u00e9cessaire et une strat\u00e9gie th\u00e9rapeutique nutritionnelle) sur la qualit\u00e9 de vie (composante physique du SF-36) des patients atteints de la 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":"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\": \"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\": \"Patient majeur d\u00e9fini comme cas confirm\u00e9 de la COVID-19 ayant \u00e9t\u00e9 hospitalis\u00e9 ou non pour COVID-19  -Date du d\u00e9but des premiers sympt\u00f4mes de la COVID-19 \u2265 4 semaines et < 4 mois  -Patients pr\u00e9sentant un d\u00e9ficit fonctionnel et\\\/ou respiratoire et\\\/ou une asth\u00e9nie et\\\/ou une d\u00e9nutrition, persistant(s) au del\u00e0 de 4 semaines des premiers sympt\u00f4mes de la COVID-19 : o Augmentation du score de dyspn\u00e9e de l\u2019\u00e9chelle mMRC \u2265 1 entre le mois pr\u00e9c\u00e9dant la COVID-19 et au-del\u00e0 des 4 premi\u00e8res semaines post-COVID-19 et\\\/ou o Score d\u2019asth\u00e9nie > 22 selon l\u2019\u00e9chelle de Pichot au-del\u00e0 des 4 premi\u00e8res semaines post-COVID-19, en l\u2019absence d\u2019asth\u00e9nie pr\u00e9sente dans le mois pr\u00e9c\u00e9dant la COVID-19 (score d\u2019asth\u00e9nie selon l\u2019\u00e9chelle de Pichot <8) et\\\/ou o Perte de poids d\u00e9clar\u00e9e > 5% en moins de 6 mois, en comparant le poids minimum du patient au cours du mois pr\u00e9c\u00e9dant la COVID-19 et son poids au-del\u00e0 des 4 premi\u00e8res semaines post-COVID-19 et\\\/ou o IMC actuel < 20 (si \u00e2ge < 70 ans) ou < 22 (si \u00e2ge \u2265 70 ans) si l\u2019IMC \u00e9tait \u2265 20 (si \u00e2ge < 70 ans) ou \u2265 22 (si \u00e2ge \u2265 70 ans) au cours du mois pr\u00e9c\u00e9dant la COVID-19\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es \u00e9conomiques']","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\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"","sources":[],"target_sample_size":"< 500 individus","response_rate":"160"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude 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