Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Health Behavior Change During COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04367337
Recruitment Status : Completed
First Posted : April 29, 2020
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
University of Social Sciences and Humanities, Warsaw

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.

Condition or disease Intervention/treatment
Health Behavior Other: No intervention

Detailed 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 6079 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing
Actual Study Start Date : March 25, 2020
Actual Primary Completion Date : September 24, 2020
Actual Study Completion Date : September 24, 2020

Group/Cohort Intervention/treatment
Poland
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

Australia
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

Canada
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

China
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

France
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

Gambia
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

Germany
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

Israel
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

Italy
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

Malaysia
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

Portugal
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

Romania
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

Singapore
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

Switzerland
Adults, general population, N = 400
Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country




Primary Outcome Measures :
  1. Handwashing adherence [ Time Frame: 1 month ]
    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).

  2. Frequency of handwashing [ Time Frame: 1 month ]
    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).


Secondary Outcome Measures :
  1. Self-efficacy [ Time Frame: 1 month ]
    4 self-efficacy questionnaire items; mean item score ranging from 1 to 4, higher scores indicate stronger self-efficacy

  2. Risk perception [ Time Frame: 1 month ]
    3 questionnaire items to assess risk perception; mean item score ranging from 1 to 5, higher scores indicate higher risk perception

  3. Outcome expectancy [ Time Frame: 1 month ]
    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

  4. Intention [ Time Frame: 1 month ]
    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)

  5. Planning [ Time Frame: 1 month ]
    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

  6. Action control [ Time Frame: 1 month ]
    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

  7. Perceived effectiveness of hand hygiene [ Time Frame: 1 month ]
    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

  8. Anxiety [ Time Frame: 1 month ]
    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

  9. Country-level COVID-19 morbidity and mortality rates [ Time Frame: 60 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults in 14 countries are recruited using the snowballing method. Data are collected using an online platform (software: Qualtricts).
Criteria

Inclusion Criteria:

  • adults (from general population) who provided informed consent to participate

Exclusion Criteria:

  • younger than <18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367337


Locations
Layout table for location information
Australia
the University of Melbourne
Melbourne, Australia
Canada
University of New Brunswick
Fredericton, Canada
China
Peking University
Beijing, China
France
University of Bordeaux
Bordeaux, France
Gambia
London School of Hygiene and Tropical Medicine (in collaboration with MRC Unit The Gambia at LSHTM)
Fajara, Gambia
Germany
Freie Universität Berlin
Berlin, Germany
Israel
Bar-Ilan University
Ramat Gan, Israel
Italy
University of Padova
Padova, Italy
Malaysia
Perdana University
Serdang, Malaysia
Poland
SWPS University of Social Sciences and Humanities
Wroclaw, Lower Silezia, Poland, 53-328
Portugal
University of Lisbon
Lisbon, Portugal
Romania
Babes-Bolyai Unversity
Cluj-Napoca, Romania
Singapore
Nanyang Technological University
Singapore, Singapore
Switzerland
University of Zurich
Zürich, Switzerland
Sponsors and Collaborators
University of Social Sciences and Humanities, Warsaw
Investigators
Layout table for investigator information
Principal Investigator: Aleksandra Luszczynska, PhD SWPS University of Social Sciences and Humanities
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
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

Layout table for additonal information
Responsible Party: University of Social Sciences and Humanities, Warsaw
ClinicalTrials.gov Identifier: NCT04367337    
Other Study ID Numbers: 3228-1BPSYPSBEH-30
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Social Sciences and Humanities, Warsaw:
General population
Adult
Handwashing
Social cognition
Anxiety
COVID-19
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases