Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001269921
Ethics application status
Approved
Date submitted
10/11/2020
Date registered
25/11/2020
Date last updated
25/11/2020
Date data sharing statement initially provided
25/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Loddon Mallee Healthcare Worker COVID-19 Study
Scientific title
The Loddon Mallee Healthcare Worker COVID-19 Study: A longitudinal cohort study exploring the impacts of COVID-19 on the health and wellbeing of the rural and regional health care workforce.
Secondary ID [1] 302750 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 319694 0
Anxiety 319695 0
Depressive symptoms 319696 0
Resilience 319799 0
Condition category
Condition code
Public Health 317622 317622 0 0
Epidemiology
Mental Health 317623 317623 0 0
Depression
Mental Health 317624 317624 0 0
Anxiety
Mental Health 317625 317625 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
This study will use a longitudinal study design to explore and describe the health and wellbeing impacts of the COVID-19 pandemic among the rural/regional healthcare Workers. Online questionnaires will be self-completed by participants every 6 months for the next three years with shorter questionnaires at 3, 9 and 15 months. The assessments include:
Patient sociodemographic questions
COVID-19 infection history
COVID-19 infection control training
Mortality
Cause of death
Morbidity
Height & weight
Disease-specific symptoms
Medication use
Resting pulse
Blood pressure
Hearing
Vision
Screening
Delayed or postponed screening
Contraception use
Hormone replacement use
Reproductive history
Personal welling index (PWI-A)
Generalised Anxiety Disorder -7 (GAD-7)
Fear of COVID-19 Scale
Impact of events scale-6 (IES-6)
Patient Health Questionnaire (PHQ-9)
Perceived Stress Scale (PSS)
Suicidal Behaviors Questionnaire-Revised (SBQ-R)
Brief Resilience Scale (BRS)
Short Form-12 (SF-12)
The Adult State (Snyder) Hope Scale
General Self Efficacy Scale
Brief COPE Scale
Penn State Worry Questionnaire (PSWQ)
Life Orientation Test-Revised (LOT-R)
Self-compassion scale: short form (SCS-SF)
Self-control and self-management behaviour scale
Childhood trauma Questionnaire - Short Form (CTQ-SF)
Mindfulness attention awareness scale (MAAS)
Big 5 Inventory-Short form
MOS (6-item cognition questions)
Duke Social Support Index
UCLA Loneliness Scale Version 3
Recent life events questionnaire (12-items)
Self-control and self-management behaviour scale
International Physical Activity Questionnaire short form
AUDIT Alcohol Screening Tool
Smoking questionnaire
Pittsburgh Sleep Quality Index
Short diet quality questions (14-items)
General Functioning Index of the McMaster Family Assessment Device (FAD)
Health services use
Job Stress Scale
Satisfaction with Work Scale
Work engagement: Utrecht Work Engagement Scale
Copernhagen Burnout Inventory
Job-stress-related presenteeism
Occupational self-efficacy scale (OSE)
The Multilevel Safety Climate (MSC) Scale
Psychologically safe workplace questionnaire
Neighborhood cohesion
Intervention code [1] 319035 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325664 0
All cause mortality will be determined by data linkage to the National Death Index
Timepoint [1] 325664 0
All cause mortality will determined at the end of years 1, 2, and 3 through record linkage.
Primary outcome [2] 325665 0
Morbidity will be determined by data linkage to medical records and through follow-up questionnaires at the end of years 1, 2 and 3.
Timepoint [2] 325665 0
Morbidity will determined at the end of years 1, 2, and 3 through record linkage and follow-up questionnaires.
Primary outcome [3] 325666 0
Anxiety will be measured using the Generalised Anxiety Disorder Scale (GAD-7)
Timepoint [3] 325666 0
Anxiety will determined every 6 months post-enrolment for a period of three years using follow-up questionnaires.
Secondary outcome [1] 388726 0
Physical functioning will determined using the Short Form-12 using baseline and follow-up questionnaires.
Timepoint [1] 388726 0
Physical functioning will determined every 6 months post-enrolment for a period of three years using follow-up questionnaires.
Secondary outcome [2] 388727 0
Quality of Life will determined using the Short Form-12 using baseline and follow-up questionnaires.
Timepoint [2] 388727 0
Quality of Life will determined every 6 months post-enrolment for a period of three years using follow-up questionnaires.
Secondary outcome [3] 388728 0
Health service utilisation will be determined using data-linkage to medical records and through online questionnaires.
Timepoint [3] 388728 0
Health service utilisation will be determined using data-linkage to medical records and through online questionnaires every 6-months for a period of three years.

Eligibility
Key inclusion criteria
• Age 18 or over
• Currently working within a Loddon Mallee health service
• Ability to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Inability to use electronic devices (required to complete the questionnaire)
• Non-English-speaking people

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
It is expected that a sample of 4000 healthcare workers will be recruited at baseline and that 20% of these participants will be lost to follow-up, resulting in approximately 3200 participants available at the end of the 3-year follow-up. This sample size still provides more than 80% power to detect the important associations examined by this study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/11/2020
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 307171 0
Government body
Name [1] 307171 0
Victorian Department of Health and Human Services
Country [1] 307171 0
Australia
Primary sponsor type
Hospital
Name
Bendigo Health
Address
100 Barnard Street Bendigo, 3550, Victoria, Australia
Country
Australia
Secondary sponsor category [1] 307767 0
University
Name [1] 307767 0
La Trobe University Rural Health School
Address [1] 307767 0
PO Box 199, Bendigo Victoria 3552
Country [1] 307767 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307285 0
Bendigo Health Human Research Ethics Committee
Ethics committee address [1] 307285 0
Ethics committee country [1] 307285 0
Australia
Date submitted for ethics approval [1] 307285 0
12/10/2020
Approval date [1] 307285 0
11/11/2020
Ethics approval number [1] 307285 0
LNR/20/BH/68671

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

Contacts
Principal investigator
Name 106686 0
A/Prof Mark McEvoy
Address 106686 0
La Trobe University Rural Health School
PO Box 199, Bendigo Victoria 3552
Country 106686 0
Australia
Phone 106686 0
+61401570809
Fax 106686 0
Email 106686 0
[email protected]
Contact person for public queries
Name 106687 0
Carol Parker
Address 106687 0
Bendigo Health
100 Barnard Street Bendigo, Victoria 3550
Country 106687 0
Australia
Phone 106687 0
+61 0354546000
Fax 106687 0
Email 106687 0
[email protected]
Contact person for scientific queries
Name 106688 0
Mark McEvoy
Address 106688 0
La Trobe University Rural Health School
PO Box 199, Bendigo Victoria 3552
Country 106688 0
Australia
Phone 106688 0
+61401570809
Fax 106688 0
Email 106688 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
No additional documents have been identified.