Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04367337
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : May 27, 2020
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
Estimated Enrollment : 5600 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
Estimated Primary Completion Date : March 24, 2021
Estimated Study Completion Date : March 24, 2021

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


Contacts
Layout table for location contacts
Contact: Aleksandra Luszczynska, PhD +48604576066 aluszczy@uccs.edu
Contact: Zofia Szczuka, MA zszczuka@swps.edu.pl

Locations
Layout table for location information
Australia
the University of Melbourne Recruiting
Melbourne, Australia
Contact: Michelle Jongenelis, PhD       michelle.jongenelis@unimelb.edu.au   
Principal Investigator: Charles Abraham, PhD         
Canada
University of New Brunswick Recruiting
Fredericton, Canada
Contact: Stephan Dombrowski, PhD       Stephan.Dombrowski@unb.ca   
Principal Investigator: Stephan Dombrowski, PhD         
China
Peking University Recruiting
Beijing, China
Contact: Yiqun Gan, PhD       ygan@pku.edu.cn   
Principal Investigator: Yiquin Gan, PhD         
France
University of Bordeaux Recruiting
Bordeaux, France
Contact: Bruno Quintard, PhD       bruno.quintard@u-bordeaux.fr   
Principal Investigator: Bruno Quintard, PhD         
Gambia
London School of Hygiene and Tropical Medicine (in collaboration with MRC Unit The Gambia at LSHTM) Not yet recruiting
Fajara, Gambia
Contact: Vishna Shah, PhD       vishna.shah@lshtm.ac.uk   
Principal Investigator: Vishna Shah, PhD         
Germany
Freie Universität Berlin Recruiting
Berlin, Germany
Contact: Jan Keller, PhD       jan.keller@fu-berlin.de   
Principal Investigator: Nina Knoll, PhD         
Israel
Bar-Ilan University Recruiting
Ramat Gan, Israel
Contact: Noa Vilchinsky, PhD       Noa.Vilchinsky@biu.ac.il   
Principal Investigator: Noa Vilchinsky, PhD         
Italy
University of Padova Recruiting
Padova, Italy
Contact: Sabrina Cipolletta, PhD       sabrina.cipolletta@unipd.it   
Principal Investigator: Sabrina Cipolletta, PhD         
Malaysia
Perdana University Recruiting
Serdang, Malaysia
Contact: Karen Morgan, PhD       karenmorgan@perdanauniversity.edu.my   
Principal Investigator: Karen Morgan, PhD         
Poland
SWPS University of Social Sciences and Humanities Recruiting
Wroclaw, Lower Silezia, Poland, 53-328
Contact: Katarzyna Byrka, PhD       kbyrka@swps.edu.pl   
Contact: Martyna Kuszneruk, MA       mkuszneruk@swps.edu.pl   
Sub-Investigator: Zofia Szczuka, MA         
Portugal
University of Lisbon Recruiting
Lisbon, Portugal
Contact: Margarida Gaspar de Matos, PhD       margarida.gaspardematos@gmail.com   
Principal Investigator: Margarida Gaspar de Matos, PhD         
Romania
Babes-Bolyai Unversity Recruiting
Cluj-Napoca, Romania
Contact: Adriana Baban, PhD       adrianababan@psychology.ro   
Principal Investigator: Adriana Baban, PhD         
Singapore
Nanyang Technological University Recruiting
Singapore, Singapore
Contact: Konstadina Griva, PhD       konstadina.griva@ntu.edu.sg   
Principal Investigator: Konstadina Griva, PhD         
Switzerland
University of Zurich Recruiting
Zürich, Switzerland
Contact: Konstantin Schenkel, MA       konstantin.schenkel@psychologie.uzh.ch   
Principal Investigator: Urte Scholz, PhD         
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: May 27, 2020
Last Verified: May 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. Further rules of data sharing will be agreed with the lead researchers in the 14 study countries and included into the Consortium Agreement (a draft expected in June 2020).

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