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CompletedNCT04367337Updated Aug 10, 2021

Health Behavior Change During COVID-19 Pandemic

An observational study in Health Behavior, sponsored by University of Social Sciences and Humanities, Warsaw. Completed at 14 sites in 14 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-10.

Sponsored by University of Social Sciences and Humanities, Warsaw · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
6,079
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Health Behavior

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Keywords

  • General population
  • Adult
  • Handwashing
  • Social cognition
  • Anxiety
  • COVID-19
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • younger than \<18 years old
04

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
6,079 participants (actual)
Patient registry
No

Groups and cohorts

  • Poland

    Adults, general population, N = 400

    Other: No intervention

  • Australia

    Adults, general population, N = 400

    Other: No intervention

  • Canada

    Adults, general population, N = 400

    Other: No intervention

  • China

    Adults, general population, N = 400

    Other: No intervention

  • France

    Adults, general population, N = 400

    Other: No intervention

  • Gambia

    Adults, general population, N = 400

    Other: No intervention

  • Germany

    Adults, general population, N = 400

    Other: No intervention

  • Israel

    Adults, general population, N = 400

    Other: No intervention

  • Italy

    Adults, general population, N = 400

    Other: No intervention

  • Malaysia

    Adults, general population, N = 400

    Other: No intervention

  • Portugal

    Adults, general population, N = 400

    Other: No intervention

  • Romania

    Adults, general population, N = 400

    Other: No intervention

  • Singapore

    Adults, general population, N = 400

    Other: No intervention

  • Switzerland

    Adults, general population, N = 400

    Other: No intervention

Interventions

  • OtherNo intervention

    Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 1 month

  2. 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).

    Time frame: 1 month

Secondary outcomes

  1. Self-efficacy

    4 self-efficacy questionnaire items; mean item score ranging from 1 to 4, higher scores indicate stronger self-efficacy

    Time frame: 1 month

  2. Risk perception

    3 questionnaire items to assess risk perception; mean item score ranging from 1 to 5, higher scores indicate higher risk perception

    Time frame: 1 month

  3. 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

    Time frame: 1 month

  4. 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)

    Time frame: 1 month

  5. 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

    Time frame: 1 month

  6. 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

    Time frame: 1 month

  7. 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

    Time frame: 1 month

  8. 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

    Time frame: 1 month

  9. 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.

    Time frame: 60 days

06

Study locations

14 sites
  • the University of Melbourne
    Melbourne, Australia
  • University of New Brunswick
    Fredericton, Canada
  • Peking University
    Beijing, China
  • University of Bordeaux
    Bordeaux, France
  • London School of Hygiene and Tropical Medicine (in collaboration with MRC Unit The Gambia at LSHTM)
    Fajara, Gambia
  • Freie Universität Berlin
    Berlin, Germany
  • Bar-Ilan University
    Ramat Gan, Israel
  • University of Padova
    Padova, Italy
  • Perdana University
    Serdang, Malaysia
  • SWPS University of Social Sciences and Humanities
    Wroclaw, Lower Silezia 53-328, Poland
  • University of Lisbon
    Lisbon, Portugal
  • Babes-Bolyai Unversity
    Cluj-Napoca, Romania
  • Nanyang Technological University
    Singapore, Singapore
  • University of Zurich
    Zürich, Switzerland
07

References and documents

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. PubMed 27049339 ↗
  • 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. PubMed 21767036 ↗
  • 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. PubMed 34871341 ↗
  • 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. PubMed 34610808 ↗

Individual participant data

Plan to share: Undecided — 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.

08

Registry details

Key details

Study ID
NCT04367337
Lead sponsor
University of Social Sciences and Humanities, Warsaw
Responsible party
Sponsor
First posted
Apr 29, 2020
Start date
Mar 25, 2020
Primary completion
Sep 24, 2020
Completion
Sep 24, 2020
Last update
Aug 10, 2021

Study contacts

Aleksandra Luszczynska, PhD
principal investigator · SWPS University of Social Sciences and Humanities

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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