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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04367337




Registration number
NCT04367337
Ethics application status
Date submitted
28/04/2020
Date registered
29/04/2020
Date last updated
24/08/2020

Titles & IDs
Public title
Health Behavior Change During COVID-19 Pandemic
Scientific title
Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing
Secondary ID [1] 0 0
3228-1BPSYPSBEH-30
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health Behavior 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Handwashing adherence - 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).
Timepoint [1] 0 0
1 month
Primary outcome [2] 0 0
Frequency of handwashing - 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).
Timepoint [2] 0 0
1 month
Secondary outcome [1] 0 0
Self-efficacy - 4 self-efficacy questionnaire items; mean item score ranging from 1 to 4, higher scores indicate stronger self-efficacy
Timepoint [1] 0 0
1 month
Secondary outcome [2] 0 0
Risk perception - 3 questionnaire items to assess risk perception; mean item score ranging from 1 to 5, higher scores indicate higher risk perception
Timepoint [2] 0 0
1 month
Secondary outcome [3] 0 0
Outcome expectancy - 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
Timepoint [3] 0 0
1 month
Secondary outcome [4] 0 0
Intention - 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)
Timepoint [4] 0 0
1 month
Secondary outcome [5] 0 0
Planning - 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
Timepoint [5] 0 0
1 month
Secondary outcome [6] 0 0
Action control - 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
Timepoint [6] 0 0
1 month
Secondary outcome [7] 0 0
Perceived effectiveness of hand hygiene - 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
Timepoint [7] 0 0
1 month
Secondary outcome [8] 0 0
Anxiety - 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
Timepoint [8] 0 0
1 month
Secondary outcome [9] 0 0
Country-level COVID-19 morbidity and mortality rates - 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.
Timepoint [9] 0 0
60 days

Eligibility
Key inclusion criteria
- adults (from general population) who provided informed consent to participate
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- younger than <18 years old

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
the University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Fredericton
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
France
State/province [3] 0 0
Bordeaux
Country [4] 0 0
Gambia
State/province [4] 0 0
Fajara
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Israel
State/province [6] 0 0
Ramat Gan
Country [7] 0 0
Italy
State/province [7] 0 0
Padova
Country [8] 0 0
Malaysia
State/province [8] 0 0
Serdang
Country [9] 0 0
Poland
State/province [9] 0 0
Lower Silezia
Country [10] 0 0
Portugal
State/province [10] 0 0
Lisbon
Country [11] 0 0
Romania
State/province [11] 0 0
Cluj-Napoca
Country [12] 0 0
Singapore
State/province [12] 0 0
Singapore
Country [13] 0 0
Switzerland
State/province [13] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Other
Name
University of Social Sciences and Humanities, Warsaw
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT04367337
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 Fernández 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
Public notes

Contacts
Principal investigator
Name 0 0
Aleksandra Luszczynska, PhD
Address 0 0
SWPS University of Social Sciences and Humanities
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications