ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12620000857909

Ethics application status

Approved

Date submitted

20/08/2020

Date registered

28/08/2020

Date last updated

28/08/2020

Date data sharing statement initially provided

28/08/2020

Date results provided

28/08/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

The impact of work loss during the COVID-19 pandemic on health and employment.

Scientific title

A prospective longitudinal study of health and employment outcomes in Australians who have lost work during the COVID-19 pandemic

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

COVID-19

mental health

physical health

psychological distress

Condition category

Condition code

Public Health

Other public health

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Exposure: Loss of job or reduction in work during the first 3 months following the introduction of public health measures to contain the spread of COVID-19 in Australia.

Participants will complete a 20 minute questionnaire via an online or telephone administered survey at baseline with further 20 minute follow-up questionnaires at 1, 3 and 6 months post-baseline interview.

Baseline questionnaire will collect data on demographic, household and pre-covid occupational characteristics as well as current state of health, employment and financial circumstances. Follow-up questionnaires will collect data on current health, employment and financial circumstances as well as health service use, actions taken to seek mental health support and job finding.

Intervention code [1]

Not applicable

Comparator / control treatment

Concurrent control group of people who have experienced no reduction in working hours during the first 3 months following the introduction of public health measures to contain the spread of COVID-19 in Australia.

Participants will complete a 20 minute questionnaire via an online or telephone administered survey at baseline with further 20 minute follow-up questionnaires at 1, 3 and 6 months post-baseline interview.

Baseline questionnaire will collect data on demographic, household and pre-covid occupational characteristics as well as current state of health, employment and financial circumstances. Follow-up questionnaires will collect data on current health, employment and financial circumstances as well as health service use, actions taken to seek mental health support and job finding.

Control group

Active

Outcomes

Primary outcome [1]

Moderate / Severe psychological distress as measured using the Kessler-6 scale

Timepoint [1]

Baseline interview, and at 1, 3 and 6 months (primary time point) post baseline interview.

Primary outcome [2]

Short Form 12 (SF-12) mental health component score

Timepoint [2]

Baseline interview, and at 1, 3 and 6 months (primary time point) post baseline interview.

Primary outcome [3]

Short Form 12 (SF-12) physical health component score

Timepoint [3]

Baseline interview, and at 1, 3 and 6 months (primary time point) post baseline interview.

Secondary outcome [1]

Working status (unemployed, employed but not working any hours, employed on reduced hours, employed at usual hours) assessed via study-specific questions included in the study questionnaire, which has been designed specifically for the study.

Timepoint [1]

Baseline interview, and at 1, 3 and 6 months post baseline interview.

Secondary outcome [2]

Number of paid hours worked in the past week assessed using study-specific questions included in the study questionnaire, which has been designed specifically for the study.

Timepoint [2]

Baseline interview, and at 1, 3 and 6 months post baseline interview.

Secondary outcome [3]

Health Service Use in the past month, assessed using a series of study-specific questions included in the study questionnaire, which has been designed specifically for the study. Health Service Use questions were adapted from those used in the Australian National Health Survey.

Timepoint [3]

1, 3 and 6 months post baseline interview

Secondary outcome [4]

Actions to manage mental health, assessed using a study-specific question included in the study questionnaire, which has been designed specifically for the study.

Timepoint [4]

1, 3 and 6 months post baseline interview

Secondary outcome [5]

Actions to find employment, assessed using a study-specific question included in the study questionnaire, which has been designed specifically for the study.

Timepoint [5]

1, 3 and 6 months post baseline interview

Eligibility

Key inclusion criteria

Age at least 18 years of age.
Living in Australia.
Employed in a paid job, or self-employed, prior the COVID-19 pandemic.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Unable to complete a telephone or web-based survey administered in English.

Study design

Purpose

Psychosocial

Duration

Longitudinal

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Primary analyses will compare two independent study groups (unaffected and lost work/lost jobs) with a dichotomous outcome (psychological distress). Based on population prevalence studies we assume a 35% incidence of moderate/severe psychological distress in the lost work group, and a 25% incidence in the unaffected group at the 6 month follow-up. Assuming alpha of 0.05 and power of 90% and equal group sizes a total sample size of 878 at the final endpoint is required (N=439 per group). Assuming 80% consent to follow-up and a 40% loss to follow-up among participants who consent to follow-up we therefore aim to enrol N=1829 at baseline.

Relationship between outcomes and exposure variables will be examined using multivariate regression models. Modelling techniques will be chosen based on the nature of the data - for example we anticipate using binary logistic regression modelling to examine the relationship between exposure and the dichotomous primary outcome of psychological distress. Models will be adjusted for multiple covariate factors including demographic, social and occupational factors collected at baseline. Primary analyses will examine the relationship between exposures and covariate collected at the baseline interview (0 months) with outcomes at 6 months. Secondary analyses will explore outcomes at other study time points.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

27/03/2020

Date of last participant enrolment

Anticipated

Actual

12/06/2020

Date of last data collection

Anticipated

31/12/2020

Actual

Sample size

Target

1829

Accrual to date

Final

2603

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Wellington Road
Clayton 3800 VIC
Australia

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

icare foundation

Address [2]

321 Kent Street
Sydney
New South Wales 2000

Country [2]

Australia

Primary sponsor type

University

Name

Monash University

Address

School of Public Health and Preventive Medicine
Monash University
Level 2, 553 St Kilda Road
Melbourne VIC 3004
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash University Research Office
Wellington Road
Clayton 3800
VIC
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

26/03/2020

Ethics approval number [1]

#24003

Summary

Brief summary

The COVID-19 Work and Health study aims to examine the health and employment of Australians who have lost their jobs or lost work during the COVID-19 pandemic. The study seeks to understand what impact job and work loss is having on mental and physical wellbeing, who is at greatest risk, and how and when people recover. We also want to know if and when people are returning to work, and how their health changes over time. For those still working, we want to know how well they have handled any changes to their work environment and how their workplaces have adapted. The study uses a prospective cohort design, with participants completing a baseline survey and then further surveys one, three and six months later. The study will track changes in people’s self-reported health, work and financial circumstances.

Trial website

www.covidstudy.net

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Alex Collie

Address

School of Public Health and Preventive Medicine
Faculty of Medicine Nursing and Health Sciences
Monash University
553 St Kilda Road
Melbourne VIC 3004
Australia

Country

Australia

Phone

+61 3 9903 0525

Fax

alex.collie@monash.edu

Contact person for public queries

Name

Alex Collie

Address

School of Public Health and Preventive Medicine
Faculty of Medicine Nursing and Health Sciences
Monash University
553 St Kilda Road
Melbourne VIC 3004
Australia

Country

Australia

Phone

+61 3 9903 0525

Fax

alex.collie@monash.edu

Contact person for scientific queries

Name

Alex Collie

Address

School of Public Health and Preventive Medicine
Faculty of Medicine Nursing and Health Sciences
Monash University
553 St Kilda Road
Melbourne VIC 3004
Australia

Country

Australia

Phone

+61 3 9903 0525

Fax

alex.collie@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Fully de-identified study data underlying published results.

When will data be available (start and end dates)?

Beginning 1 year after the end of study data collection, and for up to 5 years post completion of study data collection.

Available to whom?

On a case-by-case basis at the discretion of the study sponsor.

Available for what types of analyses?

For use in meta-analyses. For uses consistent with the study objectives and study ethical approval.

How or where can data be obtained?

Access subject to approval by Principal Investigator (Alex Collie, alex.collie@monash.edu)

What supporting documents are/will be available?

Doc. No.	Type	Email
8845	Ethical approval	alex.collie@monash.edu
8846	Analytic code	alex.collie@monash.edu
8847	Study protocol	alex.collie@monash.edu

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

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