Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000311358
Ethics application status
Approved
Date submitted
16/06/2008
Date registered
30/06/2008
Date last updated
23/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving outcome after stroke
Scientific title
imProving Outcome after Stroke (POST)
A simple intervention to improve psychological outcomes
Secondary ID [1] 607 0
Nil
Universal Trial Number (UTN)
Trial acronym
POST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 3264 0
Stroke 3265 0
Condition category
Condition code
Mental Health 3428 3428 0 0
Other mental health disorders
Stroke 3429 3429 0 0
Ischaemic
Stroke 3498 3498 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: 1 personalised postcard, sent once a month (in an envelope) for 5 months following discharge from hospital.
Participants will consent to a baseline screening assessment and interview, and contact from research staff for a period of up to six months following hospital discharge to determine their outcome and factors that might improve recovery. Specific information is archived on this site but not available for the general public to maintain blinding to treatment allocation and primary hypothesis.
Intervention code [1] 3006 0
Prevention
Comparator / control treatment
Usual/standard care: whatever follow-up usually received following discharge from hospital. This may consist of no further follow-up, one outpatient clinic visit, some form of rehabilitation etc. This varies from patient to patient and there is no 'standard' usual care.
Control group
Active

Outcomes
Primary outcome [1] 4324 0
Psychosocial outcomes assessed using standard validated questionnaires. Specific information is archived on this site but not available for the general public to maintain blinding to treatment allocation and primary hypothesis.
Timepoint [1] 4324 0
Baseline, 3 and 6 months
Secondary outcome [1] 7290 0
Psychosocial outcomes assessed using standard validated questionnaires. Specific information is archived on this site but not available for the general public to maintain blinding to treatment allocation and primary hypothesis.
Timepoint [1] 7290 0
Baseline, 3 and 6 months

Eligibility
Key inclusion criteria
Recent (within 8 weeks) stroke;
Non-depressed (<8 on Hospital Anxiety and Depression Scale depression subscale at baseline - HADS);
Fixed address in NSW;
Sufficient English to respond to study questions;
Able to provide informed consent.
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Depressed at baseline (scoring 8 or more on the HADS depression subscale)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation, independent of the recruiting centre and investigator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation table will be generated by the study statistician using appropriate software and maintained at The George by the research assistant who will randomise participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
9/09/2008
Date of last participant enrolment
Anticipated
Actual
6/07/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
201
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 939 0
2250

Funding & Sponsors
Funding source category [1] 3486 0
Other Collaborative groups
Name [1] 3486 0
Central Coast Health Research Committee
Country [1] 3486 0
Australia
Funding source category [2] 3487 0
Charities/Societies/Foundations
Name [2] 3487 0
National Stroke Foundation
Country [2] 3487 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Stroke Foundation
Address
Level 7, 461 Bourke Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 3131 0
Charities/Societies/Foundations
Name [1] 3131 0
Brain Foundation
Address [1] 3131 0
Suite 21 Regent House
37-43 Alexander Street
Crows Nest NSW 2065
Country [1] 3131 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5518 0
Hawkesbury Human Research Ethics Committee (HREC) of Northern Sydney Central Coast Area Health (NSCCH)
Ethics committee address [1] 5518 0
Level 4, Vindin House, Royal North Shore Hospital, Pacific Hwy, St Leonards NSW 2065
Ethics committee country [1] 5518 0
Australia
Date submitted for ethics approval [1] 5518 0
12/06/2008
Approval date [1] 5518 0
14/07/2008
Ethics approval number [1] 5518 0
EC00132

Summary
Brief summary
AIMS: The primary aim of this project is to determine if a simple intervention (a personalised postcard, sent monthly) improves psychosocial outcomes in patients with a recent stroke. The secondary aim is to determine appropriate outcome measures and potential mechanisms of action for a large, multi-centre, randomized controlled trial in patients surviving stroke. RESEARCH PLAN: This is a single-centre (Gosford Hospital Stroke Service), randomized, double-blind pilot/proof of concept trial of a simple intervention to improve psychosocial outcomes in patients with a recent (within 8 weeks) stroke.
Trial website
N/A
Trial related presentations / publications
1. Hackett ML, Carter G, Crimmins D, Clarke T, Maddock K, Sturm J. imProving Outcomes after STroke (POST) clinical pilot trial protocol. International Journal of Stroke, 2010;5:52-56
2. Hackett ML, Carter G, Crimmins D, Clarke T, Arblaster L, Billot L, Mysore J, Sturm J. imProving Outcomes after Stroke: results from the randomised clinical pilot trial. In press International Journal of Stroke 20th April 2012
Public notes

Contacts
Principal investigator
Name 28670 0
A/Prof Maree Hackett
Address 28670 0
The George Institute for Global Health
PO Box M201
Missenden Road
NSW 2050
Country 28670 0
Australia
Phone 28670 0
+61 2 9993 4593
Fax 28670 0
Email 28670 0
[email protected]
Contact person for public queries
Name 11827 0
A/Prof Maree Hackett
Address 11827 0
The George Institute for Global Health
PO Box M201
Missenden Road
NSW 2050
Country 11827 0
Australia
Phone 11827 0
+61 2 9993 4593
Fax 11827 0
Email 11827 0
[email protected]
Contact person for scientific queries
Name 2755 0
A/Prof Maree Hackett
Address 2755 0
The George Institute for Global Health
PO Box M201
Missenden Road
NSW 2050
Country 2755 0
Australia
Phone 2755 0
+61 2 9993 4593
Fax 2755 0
Email 2755 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.