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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

Trial acronym

SOAR

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Resilience

COVID-19

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Mental Health

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]

Not applicable

Comparator / control treatment

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At the time of interview (Time zero, cross-sectional study)

Secondary outcome [1]

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]

At the time of interview (Time zero, cross-sectional study)

Secondary outcome [2]

Resilience. Resilience will be measured using the 10-item Connor-Davidson resilience scale.

Timepoint [2]

At the time of interview (Time zero, cross-sectional study)

Secondary outcome [3]

Perceived Stress. Perceived stress will be measured using the 10-item perceived stress scale.

Timepoint [3]

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?

Key exclusion criteria

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

La Trobe University

Address [1]

Bundoora, Victoria 3086

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

Bundoora, Victoria 3086

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

La Trobe University Human Ethics Committee

Ethics committee address [1]

Plenty Road, Bundoora, Melbourne VIC 3086

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/08/2020

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Health professionals around the world face unprecedented uncertainty during the COVID-19 pandemic, and a resilient mindset is needed to both ameliorate stress and facilitate growth experiences during this difficult time. Resilience involves responding to a potentially highly disruptive event adaptively such that psychological and physical functioning is relatively preserved, and there is capacity for positive growth. The purpose of this study is to interview frontline health professionals to explore lived experiences of resilience during the COVID-19 pandemic. Specifically, we will focus on exploring modifiable sources of resilience, including psychological and lifestyle factors that Australian healthcare workers are drawing on to navigate the challenges of working through the COVID-19 pandemic.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Lydia Brown

Address

Office of the Provost, College of Science, Health and Engineering La Trobe University Plenty Road Bundoora, VIC 3086

Country

Australia

Phone

+610491604569

Fax

[email protected]

Contact person for public queries

Name

Lydia Brown

Address

Office of the Provost, College of Science, Health and Engineering La Trobe University Plenty Road Bundoora, VIC 3086

Country

Australia

Phone

+610491604569

Fax

[email protected]

Contact person for scientific queries

Name

Lydia Brown

Address

Office of the Provost, College of Science, Health and Engineering La Trobe University Plenty Road Bundoora, VIC 3086

Country

Australia

Phone

+610491604569

Fax

[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?

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.

Trial Review

Documents added manually

Documents added automatically