Trial Review

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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.
Scientific title
Personal Digital Assistant (PDA) use to improve goal-related memory failures after brain injury.
Secondary ID [1] 280401 0
No new secondary ID.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Injury 1409 0
Condition category
Condition code
Injuries and Accidents 1504 1504 0 0
Brain

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 1388 0
Rehabilitation
Comparator / control treatment
Wait-list control group will be wait listed for PDA training for 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 2081 0
Goal attainment scale score
Timepoint [1] 2081 0
Measured at baseline, 8 and 16 weeks
Secondary outcome [1] 3593 0
Memory Functioning Questionnaire
Timepoint [1] 3593 0
Measured at baseline, 8 and 16 weeks.
Secondary outcome [2] 3594 0
Rivermead Behavioural Memory Test
Timepoint [2] 3594 0
Measured at baseline, 8 and 16 weeks.
Secondary outcome [3] 3595 0
Memory Compensation Questionnaire
Timepoint [3] 3595 0
Measured at baseline, 8 and 16 weeks.
Secondary outcome [4] 3596 0
Diary of memory failures
Timepoint [4] 3596 0
Measured at baseline, 8 and 16 weeks.

Eligibility
Key inclusion criteria
An acquired brain injury, who display functional memory failures.
Minimum age
17 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physical disability which precludes participant from the use of the PDA or impaired learning capacity which precludes participant retraining.

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)
Off-site, central randomisation by non-involved person
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generator in Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Measurers will be blind to treatment group allocation
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1640 0
Charities/Societies/Foundations
Name [1] 1640 0
Royal Rehabilitation Centre Sydney
Country [1] 1640 0
Australia
Funding source category [2] 1641 0
Commercial sector/Industry
Name [2] 1641 0
Insurance Australia Group
Country [2] 1641 0
Australia
Primary sponsor type
Individual
Name
Belinda Armstrong, Royal Rehabilitation Centre Sydney
Address
Royal Rehabilitation Centre Sydney
PO Box 6, Ryde NSW 1680
Country
Australia
Secondary sponsor category [1] 1446 0
Individual
Name [1] 1446 0
Bronwyn McFarlane, Royal Rehabilitation Centre Sydney
Address [1] 1446 0
Royal Rehabilitation Centre Sydney
PO Box 6, Ryde NSW 1680
Country [1] 1446 0
Australia
Secondary sponsor category [2] 1447 0
Individual
Name [2] 1447 0
Jeanine Allaous, Royal Rehabilitation Centre Sydney
Address [2] 1447 0
Royal Rehabilitation Centre Sydney
PO Box 6, Ryde NSW 1680
Country [2] 1447 0
Australia
Secondary sponsor category [3] 1448 0
Individual
Name [3] 1448 0
Dr Natasha Lannin, Rehabilitation Studies Unit, The University of Sydney
Address [3] 1448 0
Rehabilitation Studies Unit
PO Box 6, Ryde NSW 1680
Country [3] 1448 0
Australia
Secondary sponsor category [4] 1449 0
Individual
Name [4] 1449 0
A/Prof Robyn Tate, Rehabilitation Studies Unit, The University of Sydney
Address [4] 1449 0
Rehabilitation Studies Unit
PO Box 6, Ryde NSW 1680
Country [4] 1449 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3086 0
Royal Rehabilitation Centre
Ethics committee address [1] 3086 0
Ethics committee country [1] 3086 0
Australia
Date submitted for ethics approval [1] 3086 0
Approval date [1] 3086 0
11/09/2006
Ethics approval number [1] 3086 0
06/04

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

Contacts
Principal investigator
Name 27615 0
Address 27615 0
Country 27615 0
Phone 27615 0
Fax 27615 0
Email 27615 0
Contact person for public queries
Name 10577 0
Belinda Armstrong
Address 10577 0
Royal Rehabilitation Centre Sydney
PO Box 6, RYDE NSW 1680
Country 10577 0
Australia
Phone 10577 0
+61 2 989071144
Fax 10577 0
Email 10577 0
ArmstroB@doh.health.nsw.gov.au
Contact person for scientific queries
Name 1505 0
Natasha Lannin
Address 1505 0
Rehabilitation Studies Unit
PO Box 6, RYDE NSW 1680
Country 1505 0
Australia
Phone 1505 0
+61 2 98089236
Fax 1505 0
Email 1505 0
nlannin@mail.usyd.edu.au

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.