Trial Review

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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] 283695 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver failure 4640 0
Condition category
Condition code
Public Health 4942 4942 0 0
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] 4402 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5790 0
To determine employment status post liver transplantation.
Timepoint [1] 5790 0
From the time of enrolment to the study, when the questionnaire will be administered.
Secondary outcome [1] 241784 0
Identification of psychosocial factors affecting employment, contained within the questionnaire.
Timepoint [1] 241784 0
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] 4821 0
Hospital
Name [1] 4821 0
Sir Charles Gairdner Hospital
Country [1] 4821 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedland 6009
Western Australia
Country
Australia
Secondary sponsor category [1] 4361 0
None
Name [1] 4361 0
Address [1] 4361 0
Country [1] 4361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6873 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 6873 0
Hospital Avenue
Nedland 6009
Western Australia
Ethics committee country [1] 6873 0
Australia
Date submitted for ethics approval [1] 6873 0
31/03/2009
Approval date [1] 6873 0
23/04/2009
Ethics approval number [1] 6873 0
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 29517 0
Mr Bruce Maguire
Address 29517 0
Social Work Department Sir Charles Gairdner Hospital Hospital Avenue Nedland 6009 Western Australia
Country 29517 0
Australia
Phone 29517 0
61 8 9346 4666
Fax 29517 0
61 8 9346 4609
Email 29517 0
[email protected]
Contact person for public queries
Name 12764 0
Ms Vere Berger, Senior Social Worker
Address 12764 0
Social Work Department
Sir Charles Gairdner Hospital
Hospital Avenue
Nedland 6009
Western Australia
Country 12764 0
Australia
Phone 12764 0
61 8 9346 4666
Fax 12764 0
61 8 9346 4609
Email 12764 0
[email protected]
Contact person for scientific queries
Name 3692 0
Mr Bruce Maguire, Senior Social Worker
Address 3692 0
Social Work Department
Sir Charles Gairdner Hospital
Hospital Avenue
Nedland 6009
Western Australia
Country 3692 0
Australia
Phone 3692 0
61 8 9346 4666
Fax 3692 0
61 8 9346 4609
Email 3692 0
[email protected]

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
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Documents added automatically
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