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Health Behavior Change During COVID-19 Pandemic

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ClinicalTrials.gov Identifier: NCT04367337
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of Social Sciences and Humanities, Warsaw

Tracking Information
First Submitted Date April 28, 2020
First Posted Date April 29, 2020
Last Update Posted Date July 17, 2020
Actual Study Start Date March 25, 2020
Estimated Primary Completion Date March 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2020)
  • 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).
  • 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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 28, 2020)
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Health Behavior Change During COVID-19 Pandemic
Official Title Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing
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.
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.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Health Behavior
Intervention Other: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
Study Groups/Cohorts
  • Poland
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • Australia
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • Canada
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • China
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • France
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • Gambia
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • Germany
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • Israel
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • Italy
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • Malaysia
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • Portugal
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • Romania
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • Singapore
    Adults, general population, N = 400
    Intervention: Other: No intervention
  • Switzerland
    Adults, general population, N = 400
    Intervention: Other: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 28, 2020)
5600
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 24, 2021
Estimated Primary Completion Date March 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • younger than <18 years old
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Aleksandra Luszczynska, PhD +48604576066 aluszczy@uccs.edu
Contact: Zofia Szczuka, MA zszczuka@swps.edu.pl
Listed Location Countries Australia,   Canada,   China,   France,   Gambia,   Germany,   Israel,   Italy,   Malaysia,   Poland,   Portugal,   Romania,   Singapore,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04367337
Other Study ID Numbers 3228-1BPSYPSBEH-30
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party University of Social Sciences and Humanities, Warsaw
Study Sponsor University of Social Sciences and Humanities, Warsaw
Collaborators Not Provided
Investigators
Principal Investigator: Aleksandra Luszczynska, PhD SWPS University of Social Sciences and Humanities
PRS Account University of Social Sciences and Humanities, Warsaw
Verification Date July 2020