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Trial registered on ANZCTR


Registration number
ACTRN12608000459325
Ethics application status
Approved
Date submitted
31/08/2008
Date registered
16/09/2008
Date last updated
23/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychosocial Outcomes In Stroke
Scientific title
Psychosocial Outcomes In Stroke;
A state-wide, multi-centre, three year cohort study of younger (< 65 years) stroke survivors and subsequent return to work.
Secondary ID [1] 719 0
NIL
Secondary ID [2] 253173 0
None
Universal Trial Number (UTN)
Trial acronym
POISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 3627 0
Condition category
Condition code
Stroke 3789 3789 0 0
Haemorrhagic
Stroke 3790 3790 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To observe if early psychosocial factors are associated with return to work at one year. The following indicators are observed at Baseline, 6 months and 12 months.
* Depressed Mood
* Perceptions
* Psychosocial disability

The secondary aim is to determine what the economic impact of not returning to work at 1 year is. The following main indicators will be observed at Baseline, 6 months and 12 months:
* Return to work status
* Economic hardship
* Income
* Workplace factors
* The quality of return to work
* Relative demands of the job
* Support received at work
Intervention code [1] 3338 0
Not applicable
Intervention code [2] 3411 0
Not applicable
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4686 0
Psychosocial Factors: Anxiety, Depression, Percections. These will be determined by: Hospital Anxiety and Depression Scale (HADS), WHO Disability Assessment Schedule II
Timepoint [1] 4686 0
Baseline, 6 Months, 12 Months
Secondary outcome [1] 7902 0
Economic hardship will be measured as a dichotomous variable based on a series of questions about failure to make household payments and whether there was help provided by any organisation or individual. A respondent reporting one or more failures to make payments or the need for help in making payments will be identified as a case of economic hardship. This will be measured at baseline for the 3 months prior to the stroke and at each follow-up visit. An advantage of this measure is that it is sensitive to the possibility that individuals do prioritise certain payments (e.g. default on power bills to pay rent). The basis for these questions is the US Census Survey of Income and Program Participationsurvivors and their families.
Timepoint [1] 7902 0
Baseline, 6 Months and 12 Months

Eligibility
Key inclusion criteria
Aged 18 - 65 years of age;
Able to read or understand English;
Stroke in the previous four weeks.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to understand English sufficiently to complete questionnaires.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1123 0
2000

Funding & Sponsors
Funding source category [1] 3805 0
Government body
Name [1] 3805 0
National Health and Medical Research Council (NHMRC)
Address [1] 3805 0
GPO Box 1421 Canberra ACT 2601
Country [1] 3805 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC)
Address
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 3415 0
None
Name [1] 3415 0
Address [1] 3415 0
Country [1] 3415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5861 0
Sydney South West Area Health Service Human Research Ethics Committee (HREC)
Ethics committee address [1] 5861 0
Royal Prince Alfred Hospital (RPAH), Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 5861 0
Australia
Date submitted for ethics approval [1] 5861 0
Approval date [1] 5861 0
23/04/2008
Ethics approval number [1] 5861 0
08/RPAH/180

Summary
Brief summary
An observational stroke cohort study of younger (18-65 years) patients admitted to a stroke units in NSW surviving to 28 days. 440 participants will be enrolled from approximately 20 stroke units over a 12 month recruitment period commencing August 2008. Following admission, and prior to 28 days post stroke, all stroke survivors aged between 18 and 65 years will be invited to be interviewed and data will be collected on demographic information, the stroke event (extracted from hospital records) and psychiatric history. At 28 days, and 6 and 12 months following their stroke data will be collected on psychosocial disability using the World Health Organisation Disability Assessment Schedule (WHO-DAS) and mood from participants during telephone interviews conducted by trained researchers based at The George Institute. The primary objective is to determine if treatable early (within 28 days of stroke) psychosocial factors are associated with return to work (paid and unpaid) at one year. The secondary objective is to determine the economic impact of not returning to work for stroke survivors.
Trial website
Trial related presentations / publications
1. Hackett ML, Glozier N, Jan S, Lindley R. Psychosocial Outcomes in StrokE: the POISE observational stroke study protocol. BMC Neurology 2009, 9:24, doi:10.1186/1471-2377-9-24
2. Hackett ML, Glozier N, Jan S, Lindley R. Returning to Paid Employment after Stroke: The Psychosocial Outcomes In StrokE (POISE) Cohort Study. PLoS ONE 2012;7(7):e41795. doi:10.1371/journal.pone.0041795
3. Essue B, Hackett M, Glozier N, Lindley R, Jan S. How are household economic circumstances affected after a stroke? The Psychosocial Outcomes In StrokE (POISE) study. Stroke 2012;43(11):3110-3113
4. Jan S, Essue B, Glozier N, Lindley R, Li Q, Hackett ML. Are rehabilitation services following stroke accessed equitably in Australia? Findings from the Psychosocial Outcomes in Stroke (POISE) cohort study. BMC Public Health. In press 3rd Sep 2013
Public notes

Contacts
Principal investigator
Name 28888 0
A/Prof Maree Hackett
Address 28888 0
The George Institute
PO BOX M201
Missenden Rd
Camperdown
NSW 2050
Country 28888 0
Australia
Phone 28888 0
+61 2 9993 4593
Fax 28888 0
Email 28888 0
mhackett@georgeinstitute.org.au
Contact person for public queries
Name 12045 0
A/Prof Maree Hackett
Address 12045 0
The George Institute
PO BOX M201
Missenden Rd
Camperdown NSW 2050
Country 12045 0
Australia
Phone 12045 0
(02) 9993 4541
Fax 12045 0
(02) 9993 4502
Email 12045 0
mhackett@georgeinstitute.org.au
Contact person for scientific queries
Name 2973 0
A/Prof Maree Hackett
Address 2973 0
The George Institute
PO BOX M201
Missenden Rd
Camperdown NSW 2050
Country 2973 0
Australia
Phone 2973 0
(02) 9993 4541
Fax 2973 0
(02) 9993 4502
Email 2973 0
mhackett@georgeinstitute.org.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary