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.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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-
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Oslo, Noorwegen, 0218
- SATS Training
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Geen tussenkomst: No training
No access to training at membership training facility
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
COVID-19 RNA test positivity
Tijdsspanne: 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
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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individuals with COVID-19 antibodies
Tijdsspanne: 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
Tijdsspanne: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
|
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Magnus Løberg, MD PhD, University of Oslo
- Hoofdonderzoeker: Mette Kalager, MD PhD, University of Oslo
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- REK 143984
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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