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Trial registered on ANZCTR
Registration number
ACTRN12606000437561
Ethics application status
Approved
Date submitted
3/10/2006
Date registered
11/10/2006
Date last updated
25/04/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Improving prospective memory after brain injury.
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Scientific title
Personal Digital Assistant (PDA) use to improve goal-related memory failures after brain injury.
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Secondary ID [1]
280401
0
No new secondary ID.
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Brain Injury
1409
0
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Condition category
Condition code
Injuries and Accidents
1504
1504
0
0
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Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention group will receive occupational therapy training and use of a PDA for 8 weeks. Training will be individualised to each participant with respect to length and number of sessions however all participants will complete 8 PDA training modules. Modules cover content including:
During this 8 weeks, participants will receive training in use of paper diary and/or wall calendar, training to use task lists including prioritisation, and general time management education.
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Intervention code [1]
1388
0
Rehabilitation
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Comparator / control treatment
Wait-list control group will be wait listed for PDA training for 8 weeks.
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Control group
Active
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Outcomes
Primary outcome [1]
2081
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Goal attainment scale score
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Assessment method [1]
2081
0
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Timepoint [1]
2081
0
Measured at baseline, 8 and 16 weeks
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Secondary outcome [1]
3593
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Memory Functioning Questionnaire
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Assessment method [1]
3593
0
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Timepoint [1]
3593
0
Measured at baseline, 8 and 16 weeks.
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Secondary outcome [2]
3594
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Rivermead Behavioural Memory Test
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Assessment method [2]
3594
0
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Timepoint [2]
3594
0
Measured at baseline, 8 and 16 weeks.
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Secondary outcome [3]
3595
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Memory Compensation Questionnaire
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Assessment method [3]
3595
0
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Timepoint [3]
3595
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Measured at baseline, 8 and 16 weeks.
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Secondary outcome [4]
3596
0
Diary of memory failures
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Assessment method [4]
3596
0
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Timepoint [4]
3596
0
Measured at baseline, 8 and 16 weeks.
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Eligibility
Key inclusion criteria
An acquired brain injury, who display functional memory failures.
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Minimum age
17
Years
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Physical disability which precludes participant from the use of the PDA or impaired learning capacity which precludes participant retraining.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Off-site, central randomisation by non-involved person
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generator in Microsoft Excel
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Measurers will be blind to treatment group allocation
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
30/10/2006
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
42
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
1640
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Charities/Societies/Foundations
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Name [1]
1640
0
Royal Rehabilitation Centre Sydney
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Address [1]
1640
0
PO Box 6 Ryde NSW 1680
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Country [1]
1640
0
Australia
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Funding source category [2]
1641
0
Commercial sector/Industry
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Name [2]
1641
0
Insurance Australia Group
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Address [2]
1641
0
Insurance Australia Group Limited (IAG)
Level 26
388 George Street
Sydney NSW 2000
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Country [2]
1641
0
Australia
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Primary sponsor type
Individual
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Name
Belinda Armstrong, Royal Rehabilitation Centre Sydney
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Address
Royal Rehabilitation Centre Sydney
PO Box 6, Ryde NSW 1680
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Country
Australia
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Secondary sponsor category [1]
1446
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Individual
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Name [1]
1446
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Bronwyn McFarlane, Royal Rehabilitation Centre Sydney
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Address [1]
1446
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Royal Rehabilitation Centre Sydney
PO Box 6, Ryde NSW 1680
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Country [1]
1446
0
Australia
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Secondary sponsor category [2]
1447
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Individual
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Name [2]
1447
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Jeanine Allaous, Royal Rehabilitation Centre Sydney
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Address [2]
1447
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Royal Rehabilitation Centre Sydney
PO Box 6, Ryde NSW 1680
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Country [2]
1447
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Australia
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Secondary sponsor category [3]
1448
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Individual
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Name [3]
1448
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Dr Natasha Lannin, Rehabilitation Studies Unit, The University of Sydney
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Address [3]
1448
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Rehabilitation Studies Unit
PO Box 6, Ryde NSW 1680
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Country [3]
1448
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Australia
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Secondary sponsor category [4]
1449
0
Individual
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Name [4]
1449
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A/Prof Robyn Tate, Rehabilitation Studies Unit, The University of Sydney
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Address [4]
1449
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Rehabilitation Studies Unit
PO Box 6, Ryde NSW 1680
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Country [4]
1449
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
3086
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Royal Rehabilitation Centre
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Ethics committee address [1]
3086
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Ethics committee country [1]
3086
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Australia
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Date submitted for ethics approval [1]
3086
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Approval date [1]
3086
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11/09/2006
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Ethics approval number [1]
3086
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06/04
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Summary
Brief summary
People with brain injuries often experience problems with prospective memory. Prospective memory is memory to complete future tasks, such as recalling to pick up milk on the way home, or remembering to keep an appointment. It is common for people with poor prospective memory to use a memory device. With improvements in technology increasing the use of Personal Digital Assistants (PDA) in the non-brain injured population, anecdotal evidence suggests that PDAs would allow people with brain injuries to recall important information. Despite their increasing popularity, no studies have determined the effectiveness of PDAs for promoting prospective memory recall after brain injury. Results of the study will provide clinicians with evidence to support or refute the use of PDAs for the management of memory impairment in adults with brain injury.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
27615
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Address
27615
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Country
27615
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Phone
27615
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Fax
27615
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Email
27615
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Contact person for public queries
Name
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Belinda Armstrong
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Address
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Royal Rehabilitation Centre Sydney
PO Box 6, RYDE NSW 1680
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Country
10577
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Australia
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Phone
10577
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+61 2 989071144
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Fax
10577
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Email
10577
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[email protected]
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Contact person for scientific queries
Name
1505
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Natasha Lannin
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Address
1505
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Rehabilitation Studies Unit
PO Box 6, RYDE NSW 1680
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Country
1505
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Australia
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Phone
1505
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+61 2 98089236
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Fax
1505
0
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Email
1505
0
[email protected]
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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.
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