Health BehaviorNCT04367337
Health Behavior Change During COVID-19 Pandemic
An observational study of Health Behavior, run by University of Social Sciences and Humanities, Warsaw at 14 sites in 14 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- How many people
- 6,079 participants
- Where
- 14 sitesin 14 countries
- Study dates
- 25 Mar 2020to 24 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults in 14 countries are recruited using the snowballing method. Data are collected using an online platform (software: Qualtricts).
Who may be able to join
- adults (from general population) who provided informed consent to participate
Who cannot join
- younger than <18 years old
Trial locations and contacts
14 sites in 14 countries.
14 sites in 14 countries
Poland1 site
SWPS University of Social Sciences and Humanities
Wroclaw, Lower Silezia, 53-328
The Gambia1 site
London School of Hygiene and Tropical Medicine (in collaboration with MRC Unit The Gambia at LSHTM)
Fajara
About this study
Official title: 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.
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.
- Conditions
- Health Behavior
- Being tested
- No intervention
- Keywords
- General population, Adult, Handwashing, Social cognition, Anxiety, COVID-19
- Medical subject headings
- Health Behavior, Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
| Study group | Role | What they receive |
|---|---|---|
| Poland | Adults, general population, N = 400 Receives: Other: No intervention | |
| Australia | Adults, general population, N = 400 Receives: Other: No intervention | |
| Canada | Adults, general population, N = 400 Receives: Other: No intervention | |
| China | Adults, general population, N = 400 Receives: Other: No intervention | |
| France | Adults, general population, N = 400 Receives: Other: No intervention | |
| Gambia | Adults, general population, N = 400 Receives: Other: No intervention | |
| Germany | Adults, general population, N = 400 Receives: Other: No intervention | |
| Israel | Adults, general population, N = 400 Receives: Other: No intervention | |
| Italy | Adults, general population, N = 400 Receives: Other: No intervention | |
| Malaysia | Adults, general population, N = 400 Receives: Other: No intervention | |
| Portugal | Adults, general population, N = 400 Receives: Other: No intervention | |
| Romania | Adults, general population, N = 400 Receives: Other: No intervention | |
| Singapore | Adults, general population, N = 400 Receives: Other: No intervention | |
| Switzerland | Adults, general population, N = 400 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
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).
Measured: 1 month
Secondary outcomes (9)
Self-efficacy
4 self-efficacy questionnaire items; mean item score ranging from 1 to 4, higher scores indicate stronger self-efficacy
Measured: 1 month
Risk perception
3 questionnaire items to assess risk perception; mean item score ranging from 1 to 5, higher scores indicate higher risk perception
Measured: 1 month
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
Measured: 1 month
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)
Measured: 1 month
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
Measured: 1 month
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
Measured: 1 month
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
Measured: 1 month
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
Measured: 1 month
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start25 Mar 2020
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 6,079 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksandra Luszczynska, PhD, Principal investigator, SWPS University of Social Sciences and Humanities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367337
- Sponsor's protocol ID
- 3228-1BPSYPSBEH-30
- Status last verified
- Aug 2020
- First submitted
- 28 Apr 2020
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 27049339Schwarzer 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 21767036Ruiter 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
Szczuka Z, Siwa M, Abraham C, Baban A, Brooks S, Cipolletta S, Danso E, Dombrowski SU, Gan Y, Gaspar T, Gaspar de Matos M, Griva K, Jongenelis M, Keller J, Knoll N, Ma J, Abdul Awal Miah M, Morgan K, Peraud W, Quintard B, Shah V, Schenkel K, Scholz U, Schwarzer R, Taut D, Tomaino SCM, Vilchinsky N, Wolf H, Luszczynska A. Handwashing adherence during the COVID-19 pandemic: A longitudinal study based on protection motivation theory. Soc Sci Med. 2023 Jan;317:115569. doi: 10.1016/j.socscimed.2022.115569. Epub 2022 Nov 21.
PubMed 36436259Luszczynska 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 34871341Szczuka 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing
- ClinicalTrials.gov ID
- NCT04367337
- Acronym / sponsor ID
- 3228-1BPSYPSBEH-30
- Conditions
- Health Behavior
- Keywords
- General population, Adult, Handwashing, Social cognition, Anxiety, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,079 participants (actual)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Poland | – | Other: No interventionAdults, general population, N = 400 |
| Australia | – | Other: No interventionAdults, general population, N = 400 |
| Canada | – | Other: No interventionAdults, general population, N = 400 |
| China | – | Other: No interventionAdults, general population, N = 400 |
| France | – | Other: No interventionAdults, general population, N = 400 |
| Gambia | – | Other: No interventionAdults, general population, N = 400 |
| Germany | – | Other: No interventionAdults, general population, N = 400 |
| Israel | – | Other: No interventionAdults, general population, N = 400 |
| Italy | – | Other: No interventionAdults, general population, N = 400 |
| Malaysia | – | Other: No interventionAdults, general population, N = 400 |
| Portugal | – | Other: No interventionAdults, general population, N = 400 |
| Romania | – | Other: No interventionAdults, general population, N = 400 |
| Singapore | – | Other: No interventionAdults, general population, N = 400 |
| Switzerland | – | Other: No interventionAdults, general population, N = 400 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults in 14 countries are recruited using the snowballing method. Data are collected using an online platform (software: Qualtricts).
Key inclusion criteria (1 listed)
- adults (from general population) who provided informed consent to participate
Key exclusion criteria (1 listed)
- younger than <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational data collection only, accounting for COVID-19 morbidity and mortality levels within each country | Other | Australia, Canada, China, France, Gambia, Germany, Israel, Italy, Malaysia, Poland, Portugal, Romania, Singapore, Switzerland |
Primary outcome
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).
9 secondary outcomes
Self-efficacy
Time frame: 1 month
Risk perception
Time frame: 1 month
Outcome expectancy
Time frame: 1 month
Intention
Time frame: 1 month
Planning
Time frame: 1 month
Action control
Time frame: 1 month
Perceived effectiveness of hand hygiene
Time frame: 1 month
Anxiety
Time frame: 1 month
Country-level COVID-19 morbidity and mortality rates
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- BackgroundWorld Health Organization. Coronavirus disease (COVID-19) advice for the public. 2020. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public
- BackgroundCenters for Disease Control and Prevention. When and how to wash your hands. 2020. https://www.cdc.gov/handwashing/when-how-handwashing.html
- Background: PubMed 27049339Reyes 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.
- Background: PubMed 21767036Schwarzer 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.
- BackgroundRuiter 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
- Derived from this study: PubMed 36436259Szczuka Z, Siwa M, Abraham C, Baban A, Brooks S, Cipolletta S, Danso E, Dombrowski SU, Gan Y, Gaspar T, Gaspar de Matos M, Griva K, Jongenelis M, Keller J, Knoll N, Ma J, Abdul Awal Miah M, Morgan K, Peraud W, Quintard B, Shah V, Schenkel K, Scholz U, Schwarzer R, Taut D, Tomaino SCM, Vilchinsky N, Wolf H, Luszczynska A. Handwashing adherence during the COVID-19 pandemic: A longitudinal study based on protection motivation theory. Soc Sci Med. 2023 Jan;317:115569. doi: 10.1016/j.socscimed.2022.115569. Epub 2022 Nov 21.
- Derived from this study: PubMed 34871341Luszczynska 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.
- Derived from this study: PubMed 34610808Szczuka 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Luszczynska, PhD principal investigator
SWPS University of Social Sciences and Humanities
14 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior, run by University of Social Sciences and Humanities, Warsaw at 14 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Australia, Canada, China, France, Germany and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handwashing adherence (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04367337, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.