Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000684426
Ethics application status
Approved
Date submitted
23/05/2016
Date registered
25/05/2016
Date last updated
21/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The Perceive Recall Plan Perform Assessment with Stroke Survivors
Scientific title
A preliminary study of the Perceive Recall Plan Perform Assessment with stroke survivors in an early supported discharge setting
Secondary ID [1] 289282 0
Nil known
Universal Trial Number (UTN)
U1111-1183-1358
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 298865 0
Condition category
Condition code
Stroke 298934 298934 0 0
Ischaemic
Stroke 298935 298935 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ten stroke survivors will be assessed on 3 outcomes measures in their initial Occupational Therapy home visit sessions as part of an early supported discharge service.

They will be assessed with the Perceive Recall Plan Perform System of Task Analysis (PRPP). This is an observational assessment of occupational performance and cognitive strategy application. It is non-invasive and is standardised, reliable and valid. They will also be assesed on the Functional Independence Measure to measure burden of care and the Lawtons Scale to measure independence in instrumental activities of daily living. These assessments will all occur in their home and will take an average of an hour to complete. This is part of standard care and is in face to face delivery. PRPP will be conducted on two different tasks, and the other scales are once-off. These assessments will be completed within the first 5 OT home visits, ie: early in the episode of care with the service.

PRPP is an observational assessment. Participants will negotiate tasks to be assessed with their an OT at an appropriate level of challenge. They will be advised that notes will be taken and that they will receive their results once the assessment has been scored. Tasks may include using a computer, preparing a meal or shaving.
Intervention code [1] 294829 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298406 0
PRPP stage one and stage two: raw scores. This is a composite assessment.
Timepoint [1] 298406 0
Within first five OT home visits
Secondary outcome [1] 324043 0
Functional Independence Measure to assess burden of care
Timepoint [1] 324043 0
Completed within first five OT home visits
Secondary outcome [2] 324044 0
Lawtons Scale to assess independence in instrumental activities of daily living
Timepoint [2] 324044 0
Completed within first five OT home visits
Secondary outcome [3] 336226 0
Feasibility: determined by the number of complete data sets on PRPP and time requirements to use PRPP
Timepoint [3] 336226 0
During the first five sessions

Eligibility
Key inclusion criteria
Diagnosis of stroke, less than six months post stroke, 18 years and older, able to communicate in basic English, identified post-stroke cognitive impairment and able to give consent. People with aphasia are also potential participants. Recruitment must have been completed within the first four OT home visits, with the assessments being completed by the fifth visit. Participants will continue with standard care with the ESD service during and after data collection.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of a premorbid intellectual impairment, readmission to hospital prior to the assessments being completed and not receiving OT with the ESD service.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be analysed with Excel and SPSS. Descriptive statistics will be provided for demographic details and PRPP scores. Correlation tests will be performed between the three outcome measures to test for relationships

Sample is based on a similar exploratory study: Aubin, G., Chapparo, C., Gelinas, I., Stip, E., & Rainville, C. (2009). Use of the Perceive Recall Plan and Perform System of Task Analysis for persons with schizophrenia: A preliminary study. Australian Journal of Occupational Therapy, 56, 189-199.5

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/07/2016
Actual
24/08/2016
Date of last participant enrolment
Anticipated
4/07/2017
Actual
24/02/2017
Date of last data collection
Anticipated
Actual
24/02/2017
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5839 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 13284 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 293659 0
Hospital
Name [1] 293659 0
South Metropolitan Health Service
Country [1] 293659 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Rehabilitation in the Home
Royal Perth Hospital
Goderich St Outpatients
Level 4
Goderich St
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 292494 0
None
Name [1] 292494 0
Address [1] 292494 0
Country [1] 292494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295096 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 295096 0
Ethics committee country [1] 295096 0
Australia
Date submitted for ethics approval [1] 295096 0
18/05/2016
Approval date [1] 295096 0
26/07/2016
Ethics approval number [1] 295096 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66110 0
Mrs Jocelyn White
Address 66110 0
C/O Rehabilitation in the Home
Royal Perth Hospital
Goderich Street Outpatients
Level 4
Perth
WA
6000
Country 66110 0
Australia
Phone 66110 0
+61 8 6477 5152
Fax 66110 0
Email 66110 0
[email protected]
Contact person for public queries
Name 66111 0
Jocelyn White
Address 66111 0
C/O Rehabilitation in the Home
Royal Perth Hospital
Goderich Street Outpatients
Level 4
Perth
WA
6000
Country 66111 0
Australia
Phone 66111 0
+61 8 6477 5152
Fax 66111 0
Email 66111 0
[email protected]
Contact person for scientific queries
Name 66112 0
Jocelyn White
Address 66112 0
C/O Rehabilitation in the Home
Royal Perth Hospital
Goderich Street Outpatients
Level
WA 4
Perth
6000
Country 66112 0
Australia
Phone 66112 0
+61 8 6477 5152
Fax 66112 0
Email 66112 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.