ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000397213

Ethics application status

Approved

Date submitted

22/04/2009

Date registered

2/06/2009

Date last updated

5/12/2013

Type of registration

Prospectively registered

Titles & IDs

Public title

Do psychosocial factors affect return to employment following liver transplantation?

Scientific title

Do psychosocial factors affect return to employment following liver transplantation?

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Liver failure

Condition category

Condition code

Public Health

Other public health

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Post transplant employment and psychosocial factors assessment questionnaire.
Each patient will be interviewed once by the researcher after signing a consent form and having viewed a research information letter. The questionnaire will be completed with the researcher to determine the patient's pre and post transplant employment status and explores psychosocial factors and demographic data. The instrument is a questionnaire used in USA research by Saab S et al (2006) modified and expanded to suit the Australian context and the aims of this research. The study will be retrospective and applied to participating liver transplant recipients from 1992 to 2009.

Intervention code [1]

Not applicable

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To determine employment status post liver transplantation.

Timepoint [1]

From the time of enrolment to the study, when the questionnaire will be administered.

Secondary outcome [1]

Identification of psychosocial factors affecting employment, contained within the questionnaire.

Timepoint [1]

From the time of enrolment to the study, when the questionnaire will be administered.

Eligibility

Key inclusion criteria

All transplanted patients who are of employable age and more than six months post-operative.

Minimum age

16 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Participants must be cognitively intact and not medically dependent.

Study design

Purpose

Psychosocial

Duration

Longitudinal

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/08/2009

Actual

22/02/2010

Date of last participant enrolment

Anticipated

Actual

26/05/2010

Date of last data collection

Anticipated

Actual

Sample size

Target

103

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital

Address [1]

Hospital Avenue
Nedland 6009
Western Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sir Charles Gairdner Hospital

Address

Hospital Avenue
Nedland 6009
Western Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner Hospital Human Research Ethics Committee

Ethics committee address [1]

Hospital Avenue
Nedland   6009
Western Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/03/2009

Approval date [1]

23/04/2009

Ethics approval number [1]

2009-036

Summary

Brief summary

Liver transplantation is established as the most effective therapy for patients who have end stage liver failure. Criteria to measure therapeutic success from a medical perspective are well established. 
Recently more attention has been focused upon quality of life issues - including societal reintegration, community engagement and employment, and their relationship to medical outcomes.

At Sir Charles Gairdner Hospital there have been 223 patients who have received a liver transplant since 1994. This study will include all liver transplant who have received a liver transplant between 1994 and 2008.

The aim of this study is to identify the relationship between specific psychosocial factors and the patient’s return to employment following liver transplant. 
The psychosocial factors to be addressed have been categorised into three groups, 
‘interpersonal’ ( e.g. family and social support, strengths), 
‘intrapersonal’ (e.g. motivation level, self esteem, evidence of depression ) and 
‘environmental’ (e.g. income, housing, education). 

Patients will be asked questions in relation to these factors; the analysis will determine the degree of relationship between the factors and the incidence of return to work following transplantation.

Hypotheses:  Patients who have positive psychosocial influences will be more likely to return to employment post transplant.

We plan to interview all patients who have had a liver transplant. 
Outcome measures include: Questionnaire covering demographic data, pre and post transplant employment details, income and educational levels. The questionnaire will also address psychosocial factors, which may influence return to work.

Trial website

Trial related presentations / publications

Presentation of initial results to The WA Liver Foundation Conference, Yallingup Western Australia, 20/05/2011.
Presentation of results to The North American Liver Transplant Social Worker Conference, San Francisco 25/10/2012.
Publication of full article accepted by Transplant Journal of Australasia for December 2013 issue.

Public notes

Contacts

Principal investigator

Name

Mr Bruce Maguire

Address

Social Work Department Sir Charles Gairdner Hospital Hospital Avenue Nedland 6009 Western Australia

Country

Australia

Phone

61 8 9346 4666

Fax

61 8 9346 4609

Bruce.Maguire@health.wa.gov.au

Contact person for public queries

Name

Vere Berger, Senior Social Worker

Address

Social Work Department
Sir Charles Gairdner Hospital
Hospital Avenue
Nedland 6009
Western Australia

Country

Australia

Phone

61 8 9346 4666

Fax

61 8 9346 4609

Vere.Berger@health.wa.gov.au

Contact person for scientific queries

Name

Bruce Maguire, Senior Social Worker

Address

Social Work Department
Sir Charles Gairdner Hospital
Hospital Avenue
Nedland 6009
Western Australia

Country

Australia

Phone

61 8 9346 4666

Fax

61 8 9346 4609

Bruce.Maguire@health.wa.gov.au

No information has been provided regarding IPD availability

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.

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