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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Oslo, Norvège, 0218
- SATS Training
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Training
Access to training at membership training facility
|
Access to training facility under national regulations for COVID control
|
|
Aucune intervention: No training
No access to training at membership training facility
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
COVID-19 RNA test positivity
Délai: At the end of Cycle 1 (cycle length is 14 days)
|
Percentage of COVID-19 RNA positive individuals
|
At the end of Cycle 1 (cycle length is 14 days)
|
|
Hospital admission for COVID-19
Délai: 7 days after the end of Cycle 1 (cycle length is 14 days)
|
Percentage of people admitted to hospital for COVID-19
|
7 days after the end of Cycle 1 (cycle length is 14 days)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
individuals with COVID-19 antibodies
Délai: 14 to 20 days after the end of Cycle 1 (cycle length is 14 days)
|
Percentage of individuals with COVID-19 antibodies by blood sampling
|
14 to 20 days after the end of Cycle 1 (cycle length is 14 days)
|
|
Percentage of individuals with health care contacts
Délai: 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
|
7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
|
|
Need of ventilator treatment after hospital admission for COVID-19
Délai: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
|
Percentage of people in need of ventilator after hosital admission for COVID-19
|
7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
|
|
ICU admission for COVID-19
Délai: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
|
Percentage of people admitted to the ICU for COVID-19
|
7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
|
|
Cause-specific death
Délai: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
|
Percentage of people who died, with cause of death (including underlying cause of death)
|
7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
|
|
COVID-19 RNA test positivity in employees at training centres
Délai: At the end of Cycle 1 (cycle length is 14 days)
|
Percentage of COVID-19 RNA positive employees who worked at the training centres during the intervention
|
At the end of Cycle 1 (cycle length is 14 days)
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Magnus Løberg, MD PhD, University of Oslo
- Chercheur principal: Mette Kalager, MD PhD, University of Oslo
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- REK 143984
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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