Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000533897
Ethics application status
Approved
Date submitted
25/03/2021
Date registered
6/05/2021
Date last updated
6/09/2024
Date data sharing statement initially provided
6/05/2021
Date results provided
6/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Coronavirus in Victorian Healthcare and Aged care workers (COVIC-HA) Cohort Study
Scientific title
Coronavirus in Victorian Healthcare and Aged care workers (COVIC-HA) Cohort Study
Secondary ID [1] 302665 0
None
Universal Trial Number (UTN)
U1111-1260-5739
Trial acronym
COVIC-HA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 319579 0
Anxiety 319580 0
Post-traumatic stress 319581 0
Subjective wellbeing 319582 0
SARS-CoV-2 infection 320062 0
Condition category
Condition code
Mental Health 317522 317522 0 0
Depression
Mental Health 317523 317523 0 0
Anxiety
Public Health 317524 317524 0 0
Health service research
Infection 317991 317991 0 0
Other infectious diseases
Respiratory 319304 319304 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The COVIC-HA Cohort Study aims to establish a cohort of Victorian healthcare and aged care workers across four different settings (first responders, hospitals, primary care, aged care) to comprehensively examine the impacts of the COVID-19 pandemic on healthcare and aged care workers and workplaces over time using a mixed-methods approach. Workers from different occupational groups (doctors, nurses, paramedics, allied health, personal care assistants and support staff) will be included. The key research activities of the study will be conducted in two phases:

Phase 1
All Participants will be invited to complete quantitative surveys (each six months apart) to monitor COVID-19 impacts during 2021-2022, and consent to data linkage. Each survey (at baseline and 6 months) should take approximately 15 minutes to complete. Survey data collected will include demographic, health and wellbeing data, and information about workers perceptions of their organisation’s response to the COVID-19 pandemic. Additionally, participants will be invited to complete occasional (brief) optional surveys circulated in response to acute changes in the COVID-19 environment. At the time of each survey, both existing and new participants at enrolled sites will be eligible to complete the survey (open cohort design). Data linkage will be done with the following administrative health datasets: a) Commonwealth Datasets: Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS); b) Victorian Datasets: Victorian Admitted Episode Database (VAED), Victorian Emergency Minimum Dataset (VEMD), Ambulance Victoria (AV) dataset

Phase 2:
A subset of the cohort will be invited to consent to voluntary participation in qualitative interviews to explore personal experiences of the COVID-19 pandemic: A sub-sample of participants will be purposively recruited for semi-structured interviews to explore their lived experiences of COVID-19. Selection will be based on characteristics determined from quantitative data (e.g. gender, work role, socioeconomic status, exposure to COVID-19) to ensure a diverse range of perspectives is represented. Up to 90 participants will be selected to complete interviews that will be conducted in 2-3 successive rounds, dependent on the thematic saturation achieved as well as the evolving COVID-19 environment. The interview length will depend on how much each participant wants to say, but it could take about 30 minutes.

Depending on participant engagement, thematic findings and COVID-19 infection patterns, some participants may be asked to participate in a second round of qualitative interviews at 12 months.

Additionally, semi-structured one-on-one interviews will be conducted with senior management personnel from each participating site. We will recruit 2-3 senior management personnel from each participating site to explore systems in place for controlling workplace risks and policies and programs in place to prepare and support workers during the COVID-19 pandemic.
Intervention code [1] 318951 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325558 0
Depression, as measured by Patient Health Questionnaire-9 (PHQ-9) score:
Timepoint [1] 325558 0
Baseline survey, and then 6-monthly surveys post baseline until end of 2022.
Primary outcome [2] 325559 0
Anxiety, as measured by Generalised Anxiety Disorder 7-item scale (GAD-7) score
Timepoint [2] 325559 0
Baseline survey, and then 6-monthly surveys post baseline until end of 2022.
Secondary outcome [1] 388392 0
Resilience, as measured by the Connor-Davidson Resilience Scale 2-item (CD-RISC-2)
Timepoint [1] 388392 0
Baseline survey, and then 6-monthly surveys post baseline until end of 2022.
Secondary outcome [2] 388393 0
Subjective wellbeing/life satisfaction, as measured by the Personal Wellbeing Index-Adult (PWI-A)
Timepoint [2] 388393 0
Baseline survey, and then 6-monthly surveys post baseline until end of 2022.
Secondary outcome [3] 388394 0
Post-traumatic stress, as measured by Impact of Event Scale-6 (IES-6) score
Timepoint [3] 388394 0
Baseline survey, and then 6-monthly surveys post baseline until end of 2022.
Secondary outcome [4] 388395 0
General health/health related quality of life, as measured by item 1 of the 36-item Short Form Survey Instrument (SF-36)
Timepoint [4] 388395 0
Baseline survey, and then 6-monthly surveys post baseline until end of 2022.
Secondary outcome [5] 395061 0
Healthcare and aged care workers' lived experiences of the COVID-19 pandemic as assessed by thematic analysis of semi-structured interviews.
Timepoint [5] 395061 0
A subset of participants will be selected to complete an interview at around the time of the baseline survey and at approximately 12 months.
Secondary outcome [6] 395062 0
Healthcare and aged care workers' perceptions of workplace responses to the pandemic as assessed by thematic analysis of semi-structured interviews
Timepoint [6] 395062 0
A subset of participants will be selected to complete an interview at around the time of the baseline survey and at approximately 12 months.

Eligibility
Key inclusion criteria
Adults aged 18 years and above who have worked in healthcare and aged care settings in Victoria during the COVID-19 pandemic and are working in these settings at the time of the first survey completion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
As the survey will only be offered in English and recruitment will be conducted online, participation will not be possible by people who are not reasonably fluent in written English or do not have access to the Internet.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Physical and psychosocial health will be assessed using standardised self-report measures of general health, quality of life, anxiety, stress, depression, burnout, professional fulfilment and resilience that are sensitive to changes with time.

Survey data will be analysed using STATA version 16 or later and SAS version 16. Descriptive statistics will be used to describe the characteristics of the sample. Primary outcomes will be summarised by the factors of interest using means (standard deviation) or frequencies (percentages) or graphical displays where appropriate. Linear mixed effects models will be used to allow comparison of continuous outcomes between groups. Comparisons between groups will be made at baseline, and changes in measures over time will be compared between groups. Regression models for baseline comparisons and comparisons of changes over time between groups will include terms for age, gender, SES decile of advantage/disadvantage (Index of relative socioeconomic advantage and disadvantage [IRSAD]), and an indicator for date of participation. Random intercepts will be included to account for the clustering of HCWs within work sites. For analysis of binary outcomes, similar random effect models will be used to estimate risk ratios and 95% confidence intervals using a logarithmic link function, or using a logistic link marginalised to obtain risk ratios if convergence problems occur. Multiple imputation using chained equations was performed to account for missing data. Data was considered missing if it arose from question-specific non-response through a response of “Not applicable” or similar, or from time-specific non-response from a respondent who completed at least one but not all surveys.

Transcripts from qualitative interviews will be analysed thematically by qualitative researchers using NVivo according an established method described by Braun and Clarke. Researchers will work together to establish a hierarchy of themes, constructed during repeated readings of all transcripts. The final set of themes will then be used to search all transcripts.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/05/2021
Date of last participant enrolment
Anticipated
31/12/2022
Actual
12/06/2022
Date of last data collection
Anticipated
30/04/2023
Actual
28/06/2022
Sample size
Target
1850
Accrual to date
Final
1667
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18191 0
The Alfred - Melbourne
Recruitment hospital [2] 18192 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 18193 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [4] 18194 0
Frankston Hospital - Frankston
Recruitment hospital [5] 18491 0
Monash Children’s Hospital - Clayton
Recruitment hospital [6] 18492 0
Dandenong Hospital - Dandenong
Recruitment hospital [7] 18493 0
Casey Hospital - Berwick
Recruitment hospital [8] 18494 0
Caulfield Hospital - Caulfield
Recruitment hospital [9] 18495 0
Sandringham Hospital - Sandringham
Recruitment postcode(s) [1] 32248 0
3004 - Melbourne
Recruitment postcode(s) [2] 32249 0
3168 - Clayton
Recruitment postcode(s) [3] 32250 0
3144 - Malvern
Recruitment postcode(s) [4] 32251 0
3199 - Frankston
Recruitment postcode(s) [5] 32809 0
3175 - Dandenong
Recruitment postcode(s) [6] 32810 0
3806 - Berwick
Recruitment postcode(s) [7] 32811 0
3162 - Caulfield
Recruitment postcode(s) [8] 32812 0
3191 - Sandringham
Recruitment postcode(s) [9] 33720 0
3186 - Brighton
Recruitment postcode(s) [10] 33721 0
3060 - Fawkner
Recruitment postcode(s) [11] 33722 0
3085 - Macleod
Recruitment postcode(s) [12] 33723 0
3145 - Malvern East
Recruitment postcode(s) [13] 33724 0
3977 - Cranbourne
Recruitment postcode(s) [14] 33725 0
3134 - Ringwood

Funding & Sponsors
Funding source category [1] 307105 0
Government body
Name [1] 307105 0
Office of Health and Medical Research, Victorian Government
Country [1] 307105 0
Australia
Funding source category [2] 307419 0
Commercial sector/Industry
Name [2] 307419 0
WorkSafe Victoria
Country [2] 307419 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Public Health and Preventive Medicine (SPHPM)
553 St Kilda Road Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 307675 0
None
Name [1] 307675 0
Address [1] 307675 0
Country [1] 307675 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307219 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 307219 0
Ethics committee country [1] 307219 0
Australia
Date submitted for ethics approval [1] 307219 0
08/10/2020
Approval date [1] 307219 0
28/10/2020
Ethics approval number [1] 307219 0
68086 (Local Reference: Project 680/20)

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

Contacts
Principal investigator
Name 106450 0
Prof Karin Leder
Address 106450 0
Monash University School of Public Health and Preventive Medicine
553 St Kilda Road, Melbourne VIC 3004
Country 106450 0
Australia
Phone 106450 0
+61 3 9903 0577
Fax 106450 0
+61 3 9903 0556
Email 106450 0
[email protected]
Contact person for public queries
Name 106451 0
Shannon Zhong
Address 106451 0
Monash University School of Public Health and Preventive Medicine
553 St Kilda Road, Melbourne VIC 3004
Country 106451 0
Australia
Phone 106451 0
+61 3 99030118
Fax 106451 0
Email 106451 0
[email protected]
Contact person for scientific queries
Name 106452 0
Sarah McGuinness
Address 106452 0
Monash University School of Public Health and Preventive Medicine
553 St Kilda Road, Melbourne VIC 3004
Country 106452 0
Australia
Phone 106452 0
+61 3 99030118
Fax 106452 0
Email 106452 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMental Health Outcomes in Australian Healthcare and Aged-Care Workers during the Second Year of the COVID-19 Pandemic.2022https://dx.doi.org/10.3390/ijerph19094951
EmbaseMental health and wellbeing of health and aged care workers in Australia, May 2021 - June 2022: a longitudinal cohort study.2023https://dx.doi.org/10.5694/mja2.51918
Dimensions AIWorkers’ compensation claims for COVID-19 among workers in healthcare and other industries during 2020–2022, Victoria, Australia2023https://doi.org/10.1136/oemed-2023-108982
Dimensions AIWorkplace leave patterns among Victorian health care workers during the COVID-19 pandemic2023https://doi.org/10.1111/imj.16238
N.B. These documents automatically identified may not have been verified by the study sponsor.