Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001240831
Ethics application status
Approved
Date submitted
26/08/2021
Date registered
14/09/2021
Date last updated
14/09/2021
Date data sharing statement initially provided
14/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
How has COVID-19 affected the daily lives and quality of life of the Australian general population, and who has been affected most?
Scientific title
How the COVID-19 pandemic and related public health orders affected the daily lives and self-reported quality of life of the Australian general population, and and investigate whether some subgroups or types of people have been impacted more than others.
Secondary ID [1] 305141 0
Nil known
Universal Trial Number (UTN)
n/a
Trial acronym
COVID-QOL AUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health-related quality of life 323392 0
Emotional wellbeing 323489 0
COVID-19 323491 0
Condition category
Condition code
Public Health 320959 320959 0 0
Other public health
Mental Health 321058 321058 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Using an online survey to assess the impact of the COVID-19 pandemic and related health orders on the daily activities and health-related quality of life of Australians during the 2020 lockdown period. The survey, which takes 25 minutes, is completed on one occasion and collects demographic variables (age, sex, work status, living arrangements, etc.) and responses from the EORTC QLQ-C30, a validated 30-item questionnaire using a Likert scales to assess health-related quality of life; the general health question (GHQ), 1 item using a Likert scale taken from the validated questionnaire, SF-36; The Kessler Psychological Distress Scale, 10-items measuring distress in the past 30 days using a Likert Scale; and two research-specific questionnaires developed by the investigators: COVID Impacts Scale (19 items with responses captured on a Likert scale and three multiple choice questions describing areas of positive or negative impact); and COVID Worry Scale (21 items with responses captured on a Likert scale).
Intervention code [1] 321550 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328732 0
Impact of COVID-19 & associated health orders on activities of daily living.
Outcome measures: COVID impacts scale (19 item study specific questionnaire),
Timepoint [1] 328732 0
survey responses collected at one timepoint between October and November 2020
Primary outcome [2] 328734 0
Impact of COVID-19 & associated health orders on self-reported health domains, including quality of life.
Outcome measures: EORTC QLQ-C30
Timepoint [2] 328734 0
survey responses collected at one timepoint between October and November 2020
Primary outcome [3] 328833 0
Impact of COVID-19 & associated health orders on activities of daily living.
Outcome measures: COVID worry scale (21 item study specific questionnaire),
Timepoint [3] 328833 0
survey responses collected at one timepoint between October and November 2020
Secondary outcome [1] 400181 0
Impact of COVID-19 & associated health orders on mental health.
Outcome measures: 10 item Kessler Psychological Distress Scale,
Timepoint [1] 400181 0
survey responses collected at one timepoint between October and November 2020
Secondary outcome [2] 400567 0
Primary outcome:
Impact of COVID-19 & associated health orders on activities of daily living.
Outcome measures: 10 study-specific questions relating to aspects of daily life
Timepoint [2] 400567 0
survey responses collected at one timepoint between October and November 2020
Secondary outcome [3] 400568 0
Primary outcome:
Impact of COVID-19 & associated health orders on self-reported health domains, including quality of life.
Outcome measures: General Health Questionnaire
Timepoint [3] 400568 0
survey responses collected at one timepoint between October and November 2020
Secondary outcome [4] 400570 0
Impact of COVID-19 & associated health orders on mental health.
Outcome measures: COVID Impacts Scale - 19 item study specific questionnaire
Timepoint [4] 400570 0
survey responses collected at one timepoint between October and November 2020

Eligibility
Key inclusion criteria
Australian adult general population with access to internet and able to understand English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusions.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Random sample
Timing
Both
Statistical methods / analysis
The impact the COVID-19 pandemic during the lockdown period in Australia and then as restrictions are eased will be analysed descriptively. Where population normative or reference data are available, t-tests and chi-square tests will be used to determine if COVID-era levels differ significantly from pre-COVID baseline data.
To determine if personal characteristics and circumstances were associated with greater or lesser impact on quality of life, multivariate regression analyses will be used to assess the strength of associations between variables assessed in the survey.
Critical p values will be adjusted downwards from the conventional p=0.05 to allow for the many comparisons we will be undertaking, and thus avoid false positive findings (type I error).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/10/2020
Date of last participant enrolment
Anticipated
Actual
10/11/2020
Date of last data collection
Anticipated
Actual
10/11/2020
Sample size
Target
2000
Accrual to date
Final
2008
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309534 0
University
Name [1] 309534 0
The University of Sydney
Country [1] 309534 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 310521 0
None
Name [1] 310521 0
Address [1] 310521 0
Country [1] 310521 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309316 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 309316 0
Ethics committee country [1] 309316 0
Australia
Date submitted for ethics approval [1] 309316 0
08/06/2020
Approval date [1] 309316 0
29/07/2020
Ethics approval number [1] 309316 0
2020/451

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

Contacts
Principal investigator
Name 113734 0
Prof Madeleine King
Address 113734 0
The University of Sydney
NSW 2006
Australia
Country 113734 0
Australia
Phone 113734 0
+61290366114
Fax 113734 0
Email 113734 0
[email protected]
Contact person for public queries
Name 113735 0
Margaret-Ann Tait
Address 113735 0
The University of Sydney
NSW 2006
Australia
Country 113735 0
Australia
Phone 113735 0
+61286271558
Fax 113735 0
Email 113735 0
[email protected]
Contact person for scientific queries
Name 113736 0
Madeleine King
Address 113736 0
The University of Sydney
NSW 2006
Australia
Country 113736 0
Australia
Phone 113736 0
+61290366114
Fax 113736 0
Email 113736 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication of final paper. No end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator
email: [email protected]


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
EmbaseHealth-related quality of life of Australians during the 2020 COVID-19 pandemic: a comparison with pre-pandemic data and factors associated with poor outcomes.2023https://dx.doi.org/10.1007/s11136-022-03222-y
N.B. These documents automatically identified may not have been verified by the study sponsor.