Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000017527
Ethics application status
Approved
Date submitted
11/01/2006
Date registered
11/01/2006
Date last updated
5/11/2018
Date data sharing statement initially provided
5/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving stroke recovery in Maori and Pacific people and their families
Scientific title
A randomised controlled study to measure the effectiveness of an educational video compared to a goal setting exercise and to a control (written pamphlet) in the treatment of stroke to improve stroke recovery for Maori and Pacific people and their families.
Secondary ID [1] 296517 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MAPSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 978 0
Condition category
Condition code
Stroke 1053 1053 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised controlled trial (multi centre).
Participants randomised to receive one of three interventions or a control. Intervention A - Educational video lasting 80 minutes
Intervention B - goal setting exercise lasting 90 minutes
Intervention C - both the video and the goal setting exercise lasting 170 minutes
Intervention code [1] 833 0
None
Comparator / control treatment
Control - written pamphlet will take 30 miutes to read
Control group
Placebo

Outcomes
Primary outcome [1] 1408 0
Short form 36 physical component
Timepoint [1] 1408 0
Measured at 6 months and 12 months after stroke
Secondary outcome [1] 2488 0
Carer strain Index
Timepoint [1] 2488 0
Measured at baseline, 6 months and 12 months after stroke.
Secondary outcome [2] 2489 0
Mortality
Timepoint [2] 2489 0
Measured at baseline, 6 months and 12 months after stroke.
Secondary outcome [3] 2490 0
Mental wellness (using Hua Oranga)
Timepoint [3] 2490 0
Measured at baseline, 6 months and 12 months after stroke.
Secondary outcome [4] 2491 0
Frenchay Activity Index
Timepoint [4] 2491 0
Measured at baseline, 6 months and 12 months after stroke.
Secondary outcome [5] 2492 0
Barthell Index
Timepoint [5] 2492 0
Measured at baseline, 6 months and 12 months after stroke.
Secondary outcome [6] 2493 0
Comorbidities (using Charlson Index)
Timepoint [6] 2493 0
Measured at baseline, 6 months and 12 months after stroke.
Secondary outcome [7] 2494 0
Discrimination (EDQ)
Timepoint [7] 2494 0
Measured at baseline, 6 months and 12 months after stroke.

Eligibility
Key inclusion criteria
Stroke using World Health Organistaion definition 'rapidly developing symptoms and/or signs of focal, and at times global, loss of cerebral function, with symptoms lasting longer than 24 hours or leading to death with no apparent cause other than that of vascualr originSelf idenitfied ethnicity as Maori, Samoan, Tongan, Cook Island Maori, Niuean, Fijian.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Can not give informed consentLiving within institution after strokeSubarachnoid haemorrhage.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once informed consent from participant, researcher to contact Randomisation Coordinator (RC). The RC will enter baseline information into a secure computerised randomisation programme which will assign that participant to a particular treatment group. The RA will then provide the intervention and ask that the participant not inform subsequent researchers of the intervention he/she received
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised programme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2006
Actual
15/03/2006
Date of last participant enrolment
Anticipated
Actual
30/09/2009
Date of last data collection
Anticipated
Actual
29/11/2010
Sample size
Target
480
Accrual to date
Final
183
Recruitment outside Australia
Country [1] 257 0
New Zealand
State/province [1] 257 0

Funding & Sponsors
Funding source category [1] 1150 0
Government body
Name [1] 1150 0
Health Research Council of New Zealand
Country [1] 1150 0
New Zealand
Primary sponsor type
Individual
Name
Dr Matire Harwood and Dr Harry McNaughton
Address
Country
Secondary sponsor category [1] 1007 0
Individual
Name [1] 1007 0
Dr Alan Barber
Address [1] 1007 0
Country [1] 1007 0
Secondary sponsor category [2] 1008 0
Individual
Name [2] 1008 0
Dr John Gommans
Address [2] 1008 0
Country [2] 1008 0
Secondary sponsor category [3] 1009 0
Individual
Name [3] 1009 0
Dr Api Talemaitoga
Address [3] 1009 0
Country [3] 1009 0
Secondary sponsor category [4] 1010 0
Individual
Name [4] 1010 0
Dr Mark Weatherall
Address [4] 1010 0
Country [4] 1010 0
Secondary sponsor category [5] 1011 0
Individual
Name [5] 1011 0
Dr Will Taylor
Address [5] 1011 0
Country [5] 1011 0
Secondary sponsor category [6] 1012 0
Individual
Name [6] 1012 0
Professor Kathryn McPherson
Address [6] 1012 0
Country [6] 1012 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2473 0
Multi Regional Ethics Commitee
Ethics committee address [1] 2473 0
Ethics committee country [1] 2473 0
New Zealand
Date submitted for ethics approval [1] 2473 0
Approval date [1] 2473 0
14/12/2005
Ethics approval number [1] 2473 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Harwood, M., Weatherall, M., Talemaitoga, A., Barber, P. A., Gommans, J., Taylor, W., . . . McNaughton, H. (2012). An assessment of the Hua Oranga outcome instrument and comparison to other outcome measures in an intervention study with Maori and Pacific people following stroke. New Zealand Medical Journal, 125(1364), 57-67. Retrieved from https://www.nzma.org.nz/

Harwood, M., Weatherall, M., Talemaitoga, A., Barber, P. A., Gommans, J., Taylor, W., . . . McNaughton, H. (2012). Taking charge after stroke: promoting self-directed rehabilitation to improve quality of life – a randomized controlled trial. Clinical Rehabilitation, 26(6), 493-501. doi:10.1177/0269215511426017

Harwood M. (2014). Invited speaker – Improving stroke outcomes. He Huliau Conference, Hawaii U.S.
Harwood M. (2013). Invited Opening Address - Understanding and improving stroke outcomes for Maori. Australasian Stroke Congress, Darwin Australia
Harwood, M. (2012). Maori and whanau taking charge of stroke recovery. In Health Research Council (Ed.), Hui Whakapiripiri. Auckland, New Zealand: Health Research Council of New Zealand. Retrieved from http://hui.hrc.govt.nz/presentations/

Harwood, M. L. (2011). Maori and stroke. In New Zealand Stroke and Neurosciences Conference. Auckland New Zealand.
Public notes

Contacts
Principal investigator
Name 35278 0
Address 35278 0
Country 35278 0
Phone 35278 0
Fax 35278 0
Email 35278 0
Contact person for public queries
Name 10022 0
Dr Matire Harwood
Address 10022 0
c/o Medical Research Institute of New Zealand (MRINZ)
PO Box 10055
Wellington
Country 10022 0
New Zealand
Phone 10022 0
+64 4 4729112
Fax 10022 0
Email 10022 0
matire.harwood@mrinz.ac.nz
Contact person for scientific queries
Name 950 0
Dr Matire Harwood and Dr Harry McNaughton
Address 950 0
c/o Medical Research Institute of New Zealand (MRINZ)
PO Box 10055
Wellington
Country 950 0
New Zealand
Phone 950 0
+64 4 4729112
Fax 950 0
Email 950 0
matire.harwood@mrinz.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.