Rapid-Cycle Re-Implementation of TRAining Facilities in Norway (TRAiN)
This study tests the randomized re-opening of training facilities in Norway in relation to the COVID-19 pandemic. The investigators will use the recently developed concept of rapid-cycle randomized implementation to assure fast and safe re-introduction of training facilities by randomized testing of access restriction and measure virus exposure and immunity as well as clinical disease during the intervention to enable safe and timely downgrading of COVID-19 restrictions.
Members of training facilities in Norway age 18 to 64 years without COVID-19 related comorbidity will after informed consent be randomised to either access to training or no access in a first 2-week cycle. Testing for COVID-19 and ascertainment of clinical disease will be performed after the first cycle. If there is no clinically meaningful difference between the arms, new cycles may be implemented subsequently, e.g. with less distancing restrictions or wider age groups.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Oslo、ノルウェー、0218
- SATS Training
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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
説明
Inclusion Criteria:
all members of participating training facilities age 18 years or older who are not at increased risk for severe COVID-19 disease (see www.fhi.no for criteria) are eligible for participation if they
- plan to use the training facility regularly during the project period
- are willing to adhere to training policies during the project
- accept assessment of project endpoints
- approve handling of data for the project
Exclusion Criteria:
- COVId-19 related comorbidity
- Age below 18 years or above 64 years
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
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Training
Access to training at membership training facility
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Access to training facility under national regulations for COVID control
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介入なし：No training
No access to training at membership training facility
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
COVID-19 RNA test positivity
時間枠：At the end of Cycle 1 (cycle length is 14 days)
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Percentage of COVID-19 RNA positive individuals
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At the end of Cycle 1 (cycle length is 14 days)
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Hospital admission for COVID-19
時間枠：7 days after the end of Cycle 1 (cycle length is 14 days)
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Percentage of people admitted to hospital for COVID-19
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7 days after the end of Cycle 1 (cycle length is 14 days)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
individuals with COVID-19 antibodies
時間枠：14 to 20 days after the end of Cycle 1 (cycle length is 14 days)
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Percentage of individuals with COVID-19 antibodies by blood sampling
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14 to 20 days after the end of Cycle 1 (cycle length is 14 days)
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Percentage of individuals with health care contacts
時間枠：7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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Percentage of people who had any contacs with primary or secondary health care services
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7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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Need of ventilator treatment after hospital admission for COVID-19
時間枠：7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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Percentage of people in need of ventilator after hosital admission for COVID-19
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7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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ICU admission for COVID-19
時間枠：7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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Percentage of people admitted to the ICU for COVID-19
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7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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Cause-specific death
時間枠：7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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Percentage of people who died, with cause of death (including underlying cause of death)
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7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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COVID-19 RNA test positivity in employees at training centres
時間枠：At the end of Cycle 1 (cycle length is 14 days)
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Percentage of COVID-19 RNA positive employees who worked at the training centres during the intervention
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At the end of Cycle 1 (cycle length is 14 days)
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協力者と研究者
捜査官
- 主任研究者：Magnus Løberg, MD PhD、University of Oslo
- 主任研究者：Mette Kalager, MD PhD、University of Oslo
出版物と役立つリンク
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
その他の研究ID番号
- REK 143984
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。
Access to training facilityの臨床試験
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University of MinnesotaNational Institute on Aging (NIA)完了