- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05197673
Identifying Risks of COVID-19 Outbreaks in Work Settings and the Implications for Control Measures
Identifying Risks of Outbreaks in Work Settings and the Implications for Control Measures
Objectives: To identify core and cross-time workplace hazards and worker's exposure prevention profile towards outbreaks in three non-healthcare work settings; to evaluate effectiveness of a theory-based educational programme on improving attitude to vaccination and virus testing in workplace; to longitudinally compare attitude of willingness to vaccination, testing of SARS-CoV-2 and changes of risk profile toward outbreaks among workers.
Design: A 5-year study comprising a randomized controlled trial (RCT) and 3 parallel longitudinal studies with baseline and follow-up repeated measurements.
Setting: Non-office, mobile and office work settings. Participants: Part I is a RCT, 294 workers will be randomised to an intervention group (a theory-based education programme) and a control group with measurements repeated at 3rd, 6th and 9th month. Part II is a longitudinal quantitative study (i.e., prospective cohort study) involving 1,495 workers recruited at the baseline and followed up for 2 years. Part III is a longitudinal qualitative study involving 26 management and frontline workers. Part IV is a longitudinal workplace hygiene study involving 6 workplaces enrolled at the baseline and followed up to conduct ventilation investigation.
Intervention: Theory-based education intervention to build positive attitude of control measures towards SARS-CoV-2 outbreak.
Main outcome measure: Workplace hygiene data (airflow, air volume, etc.); willingness to vaccination and virus tests; actual uptake of SARS-CoV-2 antibody testing.
Data analyses: Multivariate regression logistic model and thematically analysed will be performed for quantitative and qualitative analysis. Intention-to-treat analysis will be employed for RCT.
Expected results: Large dataset of longitudinal measurement of willingness to vaccination/testing and actual uptake will be documented to inform policy. Educational intervention will be developed to mitigate risks of outbreaks in workplace.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Feng Wang
- Phone Number: +85222528811
- Email: fwang@cuhk.edu.hk
Study Locations
-
-
New Territories
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Sha Tin, New Territories, Hong Kong, 00000
- The Chinese University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- currently being employed in Hong Kong
Exclusion Criteria:
- who have history of physician-diagnosed cancer and sever chronic diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
This arm will receive TPB intervention to build positive attitudes towards COVID-19 related preventive behaviour (e.g., good compliance with infection control measures, encouraging uptake of testing and vaccination), subjective norms (tackling strategies for perceived social pressure from others or normative beliefs), and improve perceived behavioural control towards risks of outbreaks in workplace.
|
Intervention group will receive TPB-based education program to improve workers' attitude toward SARS-CoV-2 and raise their intention to vaccination and virus testing.
The intervention will be implemented at the baseline with measurements repeated at the 3rd month, 6th month and 9th month.
The standardized mode of intervention includes face-to-face/online seminar (depends on the COVID-19 situation), message via mobile phone, promotion pamphlet, etc.
|
No Intervention: Control group
Control group will receive only general health information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of intention to get vaccination of SARS-CoV-2
Time Frame: 3rd, 6th and 9th month
|
A questionnaire will be used to evaluate the intention to get vaccination quantitively.
This assessment will be repeated in the 3rd, 6th and 9th month.
Change will be assessed among these time points.
|
3rd, 6th and 9th month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of intention to uptake SARS-CoV-2 antibody test
Time Frame: 3rd, 6th and 9th month
|
A questionnaire will be used to evaluate the intention to get rapid antibody test quantitively.
This assessment will be repeated in the 3rd, 6th and 9th month.
Change will be assessed among these time points.
|
3rd, 6th and 9th month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lap Ah Tse, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021.531-T
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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