Collaborative Network for Generating Scientific Evidence in COVID-19 For the Unified Health System in Brazil - RECOVER SUS-BRASIL (Recoversus)
Rede Colaborativa Para Geração de Evidência Científica em COVID-19 Para o Sistema Único de Saúde no Brasil - RECOVER SUS-BRASIL
調査の概要
詳細な説明
Study 1 procedures are clinical and sociodemographic data collected through interview at admission and results of complementary exams performed during hospitalization. Data will be collected during the participant's inclusion visit (Day 0,equivalent to the date of hospital admission) and subsequently according to in-hospital visits untill discharge moment.
The team of researchers will have access to the electronic medical record or, as the case, to the paper medical record for the collection of data and variables of the study interest, and questionnaires with specific questions from participants or family members.
A visit in 31-60 days will be made, by telephone contact, for the application by a health professional of a questionnaire on mental health and verification of the occurrence of death or hospital readmission. The mental health questionnaire includes tracking disorders, such as: depression, anxiety, post-traumatic stress disorder, suicidal ideation and insomnia [questionnaires PHQ-9, GAD-7, Abbreviated PCL-C and Index Severity of Insomnia], in addition to a questionnaire on social support [MSPSS]. Patients identified with health disorders over the telephone will be referred to specialized care by a psychiatrist. Study 2 - Data from information systems drug dispensation (SICLOM - http://www.aids.gov.br/pt-br/gestores/sistemas-de-informacao/sistema-de-controle-logistico-demedicamentos-siclom), laboratory tests (SISCEL - http : //www.aids.gov.br/pt-br/sistema-de-informacao/sistema-de-controle-de-exameslaboratoriais-da-rede-nacional-de-contagem-de), information on mortality (SIM - http://sim.saude.gov.br/) and COVID-19 case notification database will be released to the Ministry of Health, with data identified with patient name, mother's name and date of birth to enable the linkage process. This sensitive data is obtained through specific forms, which include confidentiality clauses of the data. All transport and storage of this data, whether by digital physical means (for example, CD) or via the web, will be done in encrypted form with a strong algorithm. The final database will be de-identified to guarantee the confidentiality of the participants.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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-
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São Paulo、ブラジル、01246-900
- Instituto de Infectologia Emilio Ribas
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Bahia
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Salvador、Bahia、ブラジル、41332-150
- Hospital Couto Maia/SES/BA
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Ceará
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Fortaleza、Ceará、ブラジル、60455-610
- Hospital São José de Doenças Infecciosas - HSJ / Secretaria de Saúde Fortaleza
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Minas Gerais
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Belo Horizonte、Minas Gerais、ブラジル、31270-901
- Universidade Federal De Minas Gerais
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RJ
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Rio de Janeiro、RJ、ブラジル、21040-360
- Instituto Nacional de Infectologia Evandro Chagas (Fiocruz)
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Rio de Janeiro、RJ、ブラジル、20221-161
- Hospital dos Servidores do Estado/RJ
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Rio de Janeiro、RJ、ブラジル、20270-004
- Hospital Universitário Gaffree e Guinle/HUGG/UNIRIO
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Rio de Janeiro、RJ、ブラジル、20551-030
- Hospital Universitário Pedro Ernesto/UERJ
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Rio de Janeiro、RJ、ブラジル、21941-617
- Universidade Federal do Rio de Janeiro
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Rio Grande Do Sul
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Porto Alegre、Rio Grande Do Sul、ブラジル
- Hospital Nossa Senhora da Conceicao
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Santa Maria、Rio Grande Do Sul、ブラジル、97105-900
- Universidade Federal de Santa Maria/ Pró-Reitoria de PósGraduação e Pesquisa
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Santa Catarina
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São José、Santa Catarina、ブラジル、88103-310
- Hospital Regional de São José
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São Paulo
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Sumaré、São Paulo、ブラジル、13174-530
- Hospital Estadual Sumaré Dr. Leandro Francheschini
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:Adults aged 18 years. Hospitalized for suspicious signs and symptoms of COVID-19 infection by the medical care team or confirmed by laboratory tests such as RT-PCR or rapid tests.
Exclusion Criteria:Patient or family member refusal
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Total participants
3500 participants that will have their medical forms checked
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Clinical and sociodemographic data collected through interview at admission and results of complementary tests performed during hospitalization.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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The main outcome of the study is hospital mortality
時間枠：25/05/2021
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25/05/2021
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Length of hospital stay
時間枠：25/05/2021
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25/05/2021
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協力者と研究者
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 32449420.4.1001.5262
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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