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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04367337
Other study ID # 3228-1BPSYPSBEH-30
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 25, 2020
Est. completion date September 24, 2020

Study information

Verified date August 2020
Source University of Social Sciences and Humanities, Warsaw
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This observational study aims at testing the adherence to handwashing guidelines (the World Health Organization, WHO, 2020) at two measurement points, spanning 1 month. Adults from the general population in 14 countries (Poland, Australia, Canada, China, France, Gambia, Germany, Israel, Italy, Malaysia, Portugal, Romania, Singapore, Switzerland) will provide self-report data on handwashing behavior and its social-cognitive predictors (perceived effectiveness of handwashing, risk perception, outcome expectancy, self-efficacy, intention, planning, and action control), anxiety, as well as COVID-19 morbidity and mortality rates within the country.


Recruitment information / eligibility

Status Completed
Enrollment 6079
Est. completion date September 24, 2020
Est. primary completion date September 24, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adults (from general population) who provided informed consent to participate Exclusion Criteria: - younger than <18 years old

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

Locations

Country Name City State
Australia the University of Melbourne Melbourne
Canada University of New Brunswick Fredericton
China Peking University Beijing
France University of Bordeaux Bordeaux
Gambia London School of Hygiene and Tropical Medicine (in collaboration with MRC Unit The Gambia at LSHTM) Fajara
Germany Freie Universität Berlin Berlin
Israel Bar-Ilan University Ramat Gan
Italy University of Padova Padova
Malaysia Perdana University Serdang
Poland SWPS University of Social Sciences and Humanities Wroclaw Lower Silezia
Portugal University of Lisbon Lisbon
Romania Babes-Bolyai Unversity Cluj-Napoca
Singapore Nanyang Technological University Singapore
Switzerland University of Zurich Zürich

Sponsors (1)

Lead Sponsor Collaborator
University of Social Sciences and Humanities, Warsaw

Countries where clinical trial is conducted

Australia,  Canada,  China,  France,  Gambia,  Germany,  Israel,  Italy,  Malaysia,  Poland,  Portugal,  Romania,  Singapore,  Switzerland, 

References & Publications (5)

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. — View Citation

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

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. — View Citation

World Health Organization. Coronavirus disease (COVID-19) advice for the public. 2020. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 1 month
Primary 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). 1 month
Secondary Self-efficacy 4 self-efficacy questionnaire items; mean item score ranging from 1 to 4, higher scores indicate stronger self-efficacy 1 month
Secondary Risk perception 3 questionnaire items to assess risk perception; mean item score ranging from 1 to 5, higher scores indicate higher risk perception 1 month
Secondary 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 1 month
Secondary 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) 1 month
Secondary 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 1 month
Secondary 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 1 month
Secondary 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 1 month
Secondary 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 1 month
Secondary 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. 60 days
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