Identifying Risks of COVID-19 Outbreaks in Work Settings and the Implications for Control Measures

February 6, 2024 updated by: Tse Lap Ah, Chinese University of Hong Kong

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

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.

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.
Interventional

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.
310

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
    • New Territories
      • Sha Tin, New Territories, Hong Kong, 00000
        • The Chinese University of Hong Kong

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

Description

Inclusion Criteria:

  • currently being employed in Hong Kong

Exclusion Criteria:

  • who have history of physician-diagnosed cancer and sever chronic diseases

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
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.
Behavioral: Theory of planned behaviours (TPB) based intervention
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

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
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

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
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

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.
Chinese University of Hong Kong

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: Lap Ah Tse, Chinese University of Hong Kong

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 15, 2022

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.
April 30, 2023

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.
May 30, 2023

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).
November 30, 2021

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.
January 14, 2022

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.
January 19, 2022

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.
February 7, 2024

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.
February 6, 2024

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.
February 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 2021.531-T

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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