- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04367337
Health Behavior Change During COVID-19 Pandemic
Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Berlin, Allemagne
- Freie Universität Berlin
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Melbourne, Australie
- The University of Melbourne
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Fredericton, Canada
- University of New Brunswick
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Beijing, Chine
- Peking University
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Bordeaux, France
- University of Bordeaux
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Fajara, Gambie
- London School of Hygiene and Tropical Medicine (in collaboration with MRC Unit The Gambia at LSHTM)
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Ramat Gan, Israël
- Bar-Ilan University
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Padova, Italie
- University of Padova
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Lisbon, Le Portugal
- University of Lisbon
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Serdang, Malaisie
- Perdana University
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Lower Silezia
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Wroclaw, Lower Silezia, Pologne, 53-328
- SWPS University of Social Sciences and Humanities
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Cluj-Napoca, Roumanie
- Babes-Bolyai Unversity
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Singapore, Singapour
- Nanyang Technological University
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Zürich, Suisse
- University of Zurich
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- adults (from general population) who provided informed consent to participate
Exclusion Criteria:
- younger than <18 years old
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Poland
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Australia
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Canada
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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China
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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France
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Gambia
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Germany
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Israel
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Italy
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Malaysia
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Portugal
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Romania
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Singapore
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Switzerland
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Handwashing adherence
Délai: 1 month
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The 12-item self-report measure of adherence to handwashing guidelines across situations (e.g., after visiting public spaces, after touching garbage, etc.) based on the guidelines issued by the World Health Organization and the Centers for Disease Control and Prevention.
The responses are provided on a 4-point scale, ranging from 1 (strongly disagree) to 4 (strongly agree).
Higher scores indicate better outcomes (the higher level of adherence to handwashing guidelines).
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1 month
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Frequency of handwashing
Délai: 1 month
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The 1-item self-report measure of the frequency of handwashing (for at least 20 seconds, all surfaces of the hands) daily.
The responses are provided on a 4-point scale, ranging from 1 (less than once) to 5 (more than 10 times).
Higher scores indicate better outcomes (the higher frequency of handwashing).
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1 month
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Self-efficacy
Délai: 1 month
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4 self-efficacy questionnaire items; mean item score ranging from 1 to 4, higher scores indicate stronger self-efficacy
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1 month
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Risk perception
Délai: 1 month
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3 questionnaire items to assess risk perception; mean item score ranging from 1 to 5, higher scores indicate higher risk perception
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1 month
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Outcome expectancy
Délai: 1 month
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4 items assessing positive (1 item) and negative (1 items) outcome expectancies; mean item scores ranging from 1 to 4, higher scores indicate more positive outcome expectancies
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1 month
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Intention
Délai: 1 month
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2 questionnaire items assessing intention to adhere to handwashing recommendations; mean item scores ranging from 1 to 4, higher scores indicate stronger intention to wash hands (for at least 20 seconds, all surfaces of the hands)
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1 month
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Planning
Délai: 1 month
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2 questionnaire items assessing action planning (1 item) and coping planning (1 item); mean item scores ranging from 1 to 4, higher scores indicate a higher level of self-reported planning
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1 month
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Action control
Délai: 1 month
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3 questionnaire items assessing a facet of action control, namely self-monitoring; mean item scores ranging from 1 to 4, higher scores indicate a higher level of self-reported monitoring of handwashing behavior
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1 month
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Perceived effectiveness of hand hygiene
Délai: 1 month
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1 questionnaire item assessing perceptions of handwashing as an effective means of preventing coronavirus SARS-CoV-2 infection; item scores ranging from 1 to 4, higher scores indicate a higher level of perceived effectiveness of hand hygiene
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1 month
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Anxiety
Délai: 1 month
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7-item self-report scale (Generalized Anxiety Disorder, GAD-7) scale to assess anxiety symptoms; mean item scores ranging from 1 to 4, higher scores indicate a higher level of generalized anxiety
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1 month
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Country-level COVID-19 morbidity and mortality rates
Délai: 60 days
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The daily cumulative numbers for COVID-19 morbidity and mortality in the study countries.
Published daily as the Situation Report by World Health Organization, starting on 21 January 2020.
Higher numbers indicate the higher cumulative COVID-19 morbidity and mortality rates in the country.
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60 days
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Aleksandra Luszczynska, PhD, SWPS University of Social Sciences and Humanities
Publications et liens utiles
Publications générales
- Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.
- World Health Organization. Coronavirus disease (COVID-19) advice for the public. 2020. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public
- Centers for Disease Control and Prevention. When and how to wash your hands. 2020. https://www.cdc.gov/handwashing/when-how-handwashing.html
- Reyes Fernandez B, Knoll N, Hamilton K, Schwarzer R. Social-cognitive antecedents of hand washing: Action control bridges the planning-behaviour gap. Psychol Health. 2016 Aug;31(8):993-1004. doi: 10.1080/08870446.2016.1174236. Epub 2016 Apr 26.
- Ruiter RAC, Abraham C, Kok G. Scary warnings and rational precautions: A review of the psychology of fear appeals. Psychol Health. 2011;11(1): 613-630. doi: 10.1080/08870440108405863
- Luszczynska A, Szczuka Z, Abraham C, Baban A, Brooks S, Cipolletta S, Danso E, Dombrowski SU, Gan Y, Gaspar T, de Matos MG, Griva K, Jongenelis MI, Keller J, Knoll N, Ma J, Miah MAA, Morgan K, Peraud W, Quintard B, Shah V, Schenkel K, Scholz U, Schwarzer R, Siwa M, Taut D, Tomaino SCM, Vilchinsky N, Wolf H. The Interplay Between Strictness of Policies and Individuals' Self-Regulatory Efforts: Associations with Handwashing During the COVID-19 Pandemic. Ann Behav Med. 2022 Apr 2;56(4):368-380. doi: 10.1093/abm/kaab102.
- Szczuka Z, Abraham C, Baban A, Brooks S, Cipolletta S, Danso E, Dombrowski SU, Gan Y, Gaspar T, de Matos MG, Griva K, Jongenelis M, Keller J, Knoll N, Ma J, Miah MAA, Morgan K, Peraud W, Quintard B, Shah V, Schenkel K, Scholz U, Schwarzer R, Siwa M, Szymanski K, Taut D, Tomaino SCM, Vilchinsky N, Wolf H, Luszczynska A. The trajectory of COVID-19 pandemic and handwashing adherence: findings from 14 countries. BMC Public Health. 2021 Oct 5;21(1):1791. doi: 10.1186/s12889-021-11822-5.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 3228-1BPSYPSBEH-30
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
The lead researchers in 14 countries will have full access to data collected across the countries.
In line with the Consortium Agreement (v2, 16th Jul 2020) data will be openly available under following conditions:
De-identified individual participant data that underline the results reported in publications; individual-level aggregated data (e.g., sum scores for scales) used for main analyses in respective publications; available following the publication, no end date of availability; available for analyses that are conducted to achieve aims in the approved proposal.
Due to local regulations, there are exceptions in terms of data sharing rules (stated above):
- AUSTRALIA: Data from Australia will be available for 5 years after collection.
- GERMANY, SWITZERLAND: Instead of individual-level sum scores, variance-covariance matrices will be shared.
- MALAYSIA: Data will not be shared.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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