Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000413325
Ethics application status
Approved
Date submitted
1/08/2008
Date registered
22/08/2008
Date last updated
25/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study of a structured means of eliciting goals in rehabilitation
Scientific title
In stroke patients undergoing inpatient rehabilitation does a structured approach to goal-setting compared to usual care improve life satisfaction or satisfaction with rehabilitation care
Secondary ID [1] 262917 0
COPM study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 3499 0
Disabling illness 3588 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3653 3653 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 'intervention' is administration of the Canadian Occupational Performance Measure in order to elicit goals in a structured means, with feed back of results (patient goals) to the clinical team. It is a single intervention spread over the course of a 45 minute interview and dissemination to the rehabilitation team over 72 hours.
Intervention code [1] 3220 0
Rehabilitation
Comparator / control treatment
Usual care, which pragmatically will be the normal rehabilitation team care for that clinical service, including whatever approach to goal-setting is normally used.
Control group
Active

Outcomes
Primary outcome [1] 4557 0
Schedule for the Evaluation of Individual Quality of Life
Timepoint [1] 4557 0
Discharge from hospital and 3 months later
Secondary outcome [1] 7707 0
Patient perspective of care and rehabilitation (PaPeR 2.1)
Timepoint [1] 7707 0
Discharge and 3 months
Secondary outcome [2] 7708 0
Functional Independence Measure
Timepoint [2] 7708 0
Discharge and 3 months
Secondary outcome [3] 7709 0
SF-36v2 (Health Status)
Timepoint [3] 7709 0
Discharge and 3 months

Eligibility
Key inclusion criteria
Stroke, admission to inpatient rehabilitation unit within 48 hours
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment, aphasia, non-English speaking

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomisation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1098 0
New Zealand
State/province [1] 1098 0

Funding & Sponsors
Funding source category [1] 3672 0
Government body
Name [1] 3672 0
New Zealand Health Research Council
Country [1] 3672 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 7343
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 3297 0
None
Name [1] 3297 0
Address [1] 3297 0
Country [1] 3297 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5725 0
Ethics committee address [1] 5725 0
Ethics committee country [1] 5725 0
Date submitted for ethics approval [1] 5725 0
31/07/2008
Approval date [1] 5725 0
Ethics approval number [1] 5725 0

Summary
Brief summary
This study aims to determine whether a structured approach to goal-setting for people undergoing stroke rehabilitation, using a commonly used assessment tool, improves patient outcomes or statisfaction with care.
Trial website
Trial related presentations / publications
Taylor WJ, Brown M, Levack W, McPherson KM, Reed K, Dean SG, Weatherall M. A pilot cluster randomised controlled trial of structured goal-setting following stroke. Clin Rehabil 2011 (in press).
Public notes

Contacts
Principal investigator
Name 28803 0
Address 28803 0
Country 28803 0
Phone 28803 0
Fax 28803 0
Email 28803 0
Contact person for public queries
Name 11960 0
William Levack
Address 11960 0
Rehabilitation Teaching & Research Unit
University of Otago Wellington
PO Box 7343
Wellington 6242
Country 11960 0
New Zealand
Phone 11960 0
+64 4 385 5541 ext 6279
Fax 11960 0
Email 11960 0
william.levack@otago.ac.nz
Contact person for scientific queries
Name 2888 0
William Levack
Address 2888 0
University of Otago Wellington
PO Box 7343
Wellington 6242
Country 2888 0
New Zealand
Phone 2888 0
+64 4 385 5541 ext 6279
Fax 2888 0
Email 2888 0
william.levack@otago.ac.nz

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.