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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04367337




Registration number
NCT04367337
Ethics application status
Date submitted
28/04/2020
Date registered
29/04/2020

Titles & IDs
Public title
Health Behavior Change During COVID-19 Pandemic
Scientific title
Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing
Secondary ID [1] 0 0
3228-1BPSYPSBEH-30
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health Behavior 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention

Poland - Adults, general population, N = 400

Australia - Adults, general population, N = 400

Canada - Adults, general population, N = 400

China - Adults, general population, N = 400

France - Adults, general population, N = 400

Gambia - Adults, general population, N = 400

Germany - Adults, general population, N = 400

Israel - Adults, general population, N = 400

Italy - Adults, general population, N = 400

Malaysia - Adults, general population, N = 400

Portugal - Adults, general population, N = 400

Romania - Adults, general population, N = 400

Singapore - Adults, general population, N = 400

Switzerland - Adults, general population, N = 400


Other interventions: No intervention
Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Handwashing adherence
Timepoint [1] 0 0
1 month
Primary outcome [2] 0 0
Frequency of handwashing
Timepoint [2] 0 0
1 month
Secondary outcome [1] 0 0
Self-efficacy
Timepoint [1] 0 0
1 month
Secondary outcome [2] 0 0
Risk perception
Timepoint [2] 0 0
1 month
Secondary outcome [3] 0 0
Outcome expectancy
Timepoint [3] 0 0
1 month
Secondary outcome [4] 0 0
Intention
Timepoint [4] 0 0
1 month
Secondary outcome [5] 0 0
Planning
Timepoint [5] 0 0
1 month
Secondary outcome [6] 0 0
Action control
Timepoint [6] 0 0
1 month
Secondary outcome [7] 0 0
Perceived effectiveness of hand hygiene
Timepoint [7] 0 0
1 month
Secondary outcome [8] 0 0
Anxiety
Timepoint [8] 0 0
1 month
Secondary outcome [9] 0 0
Country-level COVID-19 morbidity and mortality rates
Timepoint [9] 0 0
60 days

Eligibility
Key inclusion criteria
* adults (from general population) who provided informed consent to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* younger than <18 years old

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/09/2020
Sample size
Target
Accrual to date
Final
6079
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
the University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Fredericton
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
France
State/province [3] 0 0
Bordeaux
Country [4] 0 0
Gambia
State/province [4] 0 0
Fajara
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Israel
State/province [6] 0 0
Ramat Gan
Country [7] 0 0
Italy
State/province [7] 0 0
Padova
Country [8] 0 0
Malaysia
State/province [8] 0 0
Serdang
Country [9] 0 0
Poland
State/province [9] 0 0
Lower Silezia
Country [10] 0 0
Portugal
State/province [10] 0 0
Lisbon
Country [11] 0 0
Romania
State/province [11] 0 0
Cluj-Napoca
Country [12] 0 0
Singapore
State/province [12] 0 0
Singapore
Country [13] 0 0
Switzerland
State/province [13] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Other
Name
University of Social Sciences and Humanities, Warsaw
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aleksandra Luszczynska, PhD
Address 0 0
SWPS University of Social Sciences and Humanities
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04367337