Health Behavior Change During COVID-19 Pandemic

August 8, 2021 updated by: University of Social Sciences and Humanities, Warsaw

Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6079

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • younger than <18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1 month
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).
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
1 month
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
1 month
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
1 month
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)
1 month
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
1 month
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
1 month
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
1 month
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
1 month
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.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Social Sciences and Humanities, Warsaw

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aleksandra Luszczynska, PhD, SWPS University of Social Sciences and Humanities

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3228-1BPSYPSBEH-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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