ANZCTR - Registration

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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]

NIL

Secondary ID [2]

None

Universal Trial Number (UTN)

Trial acronym

POISE

Linked study record

Health condition

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

Stroke

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

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]

Not applicable

Intervention code [2]

Not applicable

Comparator / control treatment

Not Applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Psychosocial Factors: Anxiety, Depression, Percections. These will be determined by: Hospital Anxiety and Depression Scale (HADS), WHO Disability Assessment Schedule II

Timepoint [1]

Baseline, 6 Months, 12 Months

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/10/2008

Actual

1/10/2008

Date of last participant enrolment

Anticipated

Actual

4/06/2010

Date of last data collection

Anticipated

Actual

Sample size

Target

440

Accrual to date

Final

440

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

2000

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

GPO Box 1421 Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney South West Area Health Service Human Research Ethics Committee (HREC)

Ethics committee address [1]

Royal Prince Alfred Hospital (RPAH), Missenden Road
Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/04/2008

Ethics approval number [1]

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

A/Prof Maree Hackett

Address

The George Institute
PO BOX M201
Missenden Rd
Camperdown
NSW 2050

Country

Australia

Phone

+61 2 9993 4593

Fax

mhackett@georgeinstitute.org.au

Contact person for public queries

Name

Maree Hackett

Address

The George Institute
PO BOX M201
Missenden Rd
Camperdown NSW 2050

Country

Australia

Phone

(02) 9993 4541

Fax

(02) 9993 4502

mhackett@georgeinstitute.org.au

Contact person for scientific queries

Name

Maree Hackett

Address

The George Institute
PO BOX M201
Missenden Rd
Camperdown NSW 2050

Country

Australia

Phone

(02) 9993 4541

Fax

(02) 9993 4502

mhackett@georgeinstitute.org.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

Source	Title	Year of Publication	DOI
Embase	Driving in stroke survivors aged 18-65 years: The Psychosocial Outcomes In StrokE (POISE) Cohort Study.	2016	https://dx.doi.org/10.1177/1747493016641952
Embase	The Course and Impact of Poststroke Insomnia in Stroke Survivors Aged 18 to 65 Years: Results from the Psychosocial Outcomes in StrokE (POISE) Studya.	2017	https://dx.doi.org/10.1159/000455751
Embase	Effect of mood on long-term disability in younger stroke survivors: results from the Psychosocial Outcomes In StrokE (POISE) study.	2022	https://dx.doi.org/10.1080/10749357.2021.1922802

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

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