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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] 302074 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 318673 0
mental health 318680 0
physical health 318681 0
psychological distress 318682 0
Condition category
Condition code
Public Health 316690 316690 0 0
Other public health
Mental Health 316775 316775 0 0
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] 318373 0
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] 324822 0
Moderate / Severe psychological distress as measured using the Kessler-6 scale
Timepoint [1] 324822 0
Baseline interview, and at 1, 3 and 6 months (primary time point) post baseline interview.
Primary outcome [2] 324823 0
Short Form 12 (SF-12) mental health component score
Timepoint [2] 324823 0
Baseline interview, and at 1, 3 and 6 months (primary time point) post baseline interview.
Primary outcome [3] 324846 0
Short Form 12 (SF-12) physical health component score
Timepoint [3] 324846 0
Baseline interview, and at 1, 3 and 6 months (primary time point) post baseline interview.
Secondary outcome [1] 385851 0
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] 385851 0
Baseline interview, and at 1, 3 and 6 months post baseline interview.
Secondary outcome [2] 385853 0
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] 385853 0
Baseline interview, and at 1, 3 and 6 months post baseline interview.
Secondary outcome [3] 386139 0
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] 386139 0
1, 3 and 6 months post baseline interview
Secondary outcome [4] 386140 0
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] 386140 0
1, 3 and 6 months post baseline interview
Secondary outcome [5] 386141 0
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] 386141 0
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] 306492 0
University
Name [1] 306492 0
Monash University
Country [1] 306492 0
Australia
Funding source category [2] 306497 0
Government body
Name [2] 306497 0
icare foundation
Country [2] 306497 0
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] 307024 0
None
Name [1] 307024 0
Address [1] 307024 0
Country [1] 307024 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306698 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 306698 0
Ethics committee country [1] 306698 0
Australia
Date submitted for ethics approval [1] 306698 0
Approval date [1] 306698 0
26/03/2020
Ethics approval number [1] 306698 0
#24003

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

Contacts
Principal investigator
Name 104710 0
Prof Alex Collie
Address 104710 0
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 104710 0
Australia
Phone 104710 0
+61 3 9903 0525
Fax 104710 0
Email 104710 0
alex.collie@monash.edu
Contact person for public queries
Name 104711 0
Alex Collie
Address 104711 0
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 104711 0
Australia
Phone 104711 0
+61 3 9903 0525
Fax 104711 0
Email 104711 0
alex.collie@monash.edu
Contact person for scientific queries
Name 104712 0
Alex Collie
Address 104712 0
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 104712 0
Australia
Phone 104712 0
+61 3 9903 0525
Fax 104712 0
Email 104712 0
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.TypeCitationLinkEmailOther DetailsAttachment
8845Ethical approval  alex.collie@monash.edu
8846Analytic code  alex.collie@monash.edu
8847Study protocol  alex.collie@monash.edu


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.