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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04367337
Registration number
NCT04367337
Ethics application status
Date submitted
28/04/2020
Date registered
29/04/2020
Titles & IDs
Public title
Health Behavior Change During COVID-19 Pandemic
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Scientific title
Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing
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Secondary ID [1]
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3228-1BPSYPSBEH-30
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Health Behavior
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - No intervention
Poland - Adults, general population, N = 400
Australia - Adults, general population, N = 400
Canada - Adults, general population, N = 400
China - Adults, general population, N = 400
France - Adults, general population, N = 400
Gambia - Adults, general population, N = 400
Germany - Adults, general population, N = 400
Israel - Adults, general population, N = 400
Italy - Adults, general population, N = 400
Malaysia - Adults, general population, N = 400
Portugal - Adults, general population, N = 400
Romania - Adults, general population, N = 400
Singapore - Adults, general population, N = 400
Switzerland - Adults, general population, N = 400
Other interventions: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Handwashing adherence
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Assessment method [1]
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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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Timepoint [1]
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1 month
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Primary outcome [2]
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Frequency of handwashing
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Assessment method [2]
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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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Timepoint [2]
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1 month
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Secondary outcome [1]
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Self-efficacy
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Assessment method [1]
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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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Timepoint [1]
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1 month
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Secondary outcome [2]
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Risk perception
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Assessment method [2]
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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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Timepoint [2]
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1 month
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Secondary outcome [3]
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Outcome expectancy
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Assessment method [3]
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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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Timepoint [3]
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1 month
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Secondary outcome [4]
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Intention
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Assessment method [4]
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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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Timepoint [4]
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1 month
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Secondary outcome [5]
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Planning
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Assessment method [5]
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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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Timepoint [5]
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1 month
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Secondary outcome [6]
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Action control
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Assessment method [6]
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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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Timepoint [6]
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1 month
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Secondary outcome [7]
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Perceived effectiveness of hand hygiene
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Assessment method [7]
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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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Timepoint [7]
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1 month
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Secondary outcome [8]
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Anxiety
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Assessment method [8]
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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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Timepoint [8]
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1 month
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Secondary outcome [9]
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Country-level COVID-19 morbidity and mortality rates
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Assessment method [9]
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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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Timepoint [9]
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60 days
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Eligibility
Key inclusion criteria
* adults (from general population) who provided informed consent to participate
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* younger than <18 years old
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/09/2020
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Sample size
Target
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Accrual to date
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Final
6079
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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the University of Melbourne - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Fredericton
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Country [2]
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China
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State/province [2]
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Beijing
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Country [3]
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France
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State/province [3]
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Bordeaux
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Country [4]
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Gambia
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State/province [4]
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Fajara
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Country [5]
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Germany
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State/province [5]
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Berlin
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Country [6]
0
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Israel
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State/province [6]
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Ramat Gan
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Country [7]
0
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Italy
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State/province [7]
0
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Padova
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Country [8]
0
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Malaysia
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State/province [8]
0
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Serdang
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Country [9]
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Poland
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State/province [9]
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Lower Silezia
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Country [10]
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Portugal
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State/province [10]
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Lisbon
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Country [11]
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Romania
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State/province [11]
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Cluj-Napoca
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Country [12]
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Singapore
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State/province [12]
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Singapore
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Country [13]
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Switzerland
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State/province [13]
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Zürich
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Social Sciences and Humanities, Warsaw
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study aims at investigating handwashing behavior during COVID-19 pandemic. It was hypothesized that social-cognitive and emotional predictors as well as COVID-19 morbidity and mortality rates within the country would be associated with handwashing behavior in the general population of adults in 14 countries.
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Trial website
https://clinicaltrials.gov/study/NCT04367337
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Trial related presentations / publications
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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Aleksandra Luszczynska, PhD
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Address
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SWPS University of Social Sciences and Humanities
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04367337