Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000921987p
Ethics application status
Submitted, not yet approved
Date submitted
2/09/2020
Date registered
17/09/2020
Date last updated
17/09/2020
Date data sharing statement initially provided
17/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Sources of a Resilient Mindset in Health Professionals During COVID-19: The SOAR Study
Scientific title
Sources of a Resilient Mindset in Health Professionals During COVID-19: The SOAR Study
Secondary ID [1] 301945 0
None
Universal Trial Number (UTN)
Trial acronym
SOAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resilience 318493 0
COVID-19 318957 0
Condition category
Condition code
Mental Health 316498 316498 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 316928 316928 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
One-off semi-structured interviews of approximately 30 minute duration will be conducted to explore hospital healthcare workers experiences of resilience, and sources of resilience, that have helped them cope during the COVID-19 pandemic. Measures of resilience and stress will also be collected using validated questionnaire scales.
Intervention code [1] 318234 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324994 0
Sources of resilience. Sources of resilience is the primary outcome measure and it will be assessed during the 30 minute semi-structured interview via interview questions. (e.g. "What have you found within yourself that has given you the strength to get through this get through working during the COVID-19 pandemic?")
Timepoint [1] 324994 0
At the time of interview (Time zero, cross-sectional study)
Secondary outcome [1] 386485 0
Lived experience of working during the pandemic. This will be assessed during the 30 minute semi-structured interview via interview questions. (e.g. "How has your work changed from before the pandemic to now?").
Timepoint [1] 386485 0
At the time of interview (Time zero, cross-sectional study)
Secondary outcome [2] 386997 0
Resilience. Resilience will be measured using the 10-item Connor-Davidson resilience scale.
Timepoint [2] 386997 0
At the time of interview (Time zero, cross-sectional study)
Secondary outcome [3] 386998 0
Perceived Stress. Perceived stress will be measured using the 10-item perceived stress scale.
Timepoint [3] 386998 0
At the time of interview (Time zero, cross-sectional study)

Eligibility
Key inclusion criteria
Health professionals who have worked directly with patients who are COVID-19 positive, or with patients suspected of having COVID-19.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
NA

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Grounded Therory will be used to analyze the interview data. In this approach, existing theory is used to develop the initial coding scheme prior to coding the interviews. The scheme is then modified and refined in an iterative fashion during the coding process based on themes emerging from the interviews.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/09/2020
Actual
Date of last participant enrolment
Anticipated
25/11/2020
Actual
Date of last data collection
Anticipated
2/12/2020
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306361 0
University
Name [1] 306361 0
La Trobe University
Country [1] 306361 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Bundoora, Victoria 3086
Country
Australia
Secondary sponsor category [1] 307185 0
None
Name [1] 307185 0
Address [1] 307185 0
Country [1] 307185 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306569 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 306569 0
Ethics committee country [1] 306569 0
Australia
Date submitted for ethics approval [1] 306569 0
27/08/2020
Approval date [1] 306569 0
Ethics approval number [1] 306569 0

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

Contacts
Principal investigator
Name 104318 0
Dr Lydia Brown
Address 104318 0
Office of the Provost, College of Science, Health and Engineering La Trobe University Plenty Road Bundoora, VIC 3086
Country 104318 0
Australia
Phone 104318 0
+610491604569
Fax 104318 0
Email 104318 0
[email protected]
Contact person for public queries
Name 104319 0
Lydia Brown
Address 104319 0
Office of the Provost, College of Science, Health and Engineering La Trobe University Plenty Road Bundoora, VIC 3086
Country 104319 0
Australia
Phone 104319 0
+610491604569
Fax 104319 0
Email 104319 0
[email protected]
Contact person for scientific queries
Name 104320 0
Lydia Brown
Address 104320 0
Office of the Provost, College of Science, Health and Engineering La Trobe University Plenty Road Bundoora, VIC 3086
Country 104320 0
Australia
Phone 104320 0
+610491604569
Fax 104320 0
Email 104320 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Deidentified data will be freely available

Conditions for requesting access:
• -

What individual participant data might be shared?
• Deidentified data will be stored on Research Online, La Trobe's instutional repository for de-identified data.

What types of analyses could be done with individual participant data?
• NA

When can requests for individual participant data be made (start and end dates)?
From:
Data will be available after the publication of results in a peer-reviewed journal, in approximately 2021. De-identified data will be available indefinitely, with no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data will be available via a specific link on La Trobe's Research Online data repository (https://www.latrobe.edu.au/library/research-support/research-online). The specific link is not yet available, and this information will be updated to incorporate the specific link once it is available.

Are there extra considerations when requesting access to individual participant data?
No


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.