- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04367337
Health Behavior Change During COVID-19 Pandemic
Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing
Visão geral do estudo
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Berlin, Alemanha
- Freie Universität Berlin
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Melbourne, Austrália
- The University of Melbourne
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Fredericton, Canadá
- University of New Brunswick
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Beijing, China
- Peking University
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Singapore, Cingapura
- Nanyang Technological University
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Bordeaux, França
- University of Bordeaux
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Fajara, Gâmbia
- London School of Hygiene and Tropical Medicine (in collaboration with MRC Unit The Gambia at LSHTM)
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Ramat Gan, Israel
- Bar-Ilan University
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Padova, Itália
- University of Padova
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Serdang, Malásia
- Perdana University
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Lower Silezia
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Wroclaw, Lower Silezia, Polônia, 53-328
- SWPS University of Social Sciences and Humanities
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Lisbon, Portugal
- University of Lisbon
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Cluj-Napoca, Romênia
- Babes-Bolyai Unversity
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Zürich, Suíça
- University of Zurich
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- adults (from general population) who provided informed consent to participate
Exclusion Criteria:
- younger than <18 years old
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Handwashing adherence
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Self-efficacy
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Aleksandra Luszczynska, PhD, SWPS University of Social Sciences and Humanities
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 3228-1BPSYPSBEH-30
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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