Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000754640
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
17/11/2005
Date last updated
17/11/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of prospective memory rehabilitation programmes for adults with traumatic brain injury
Scientific title
Evaluation of rehabilitation strategies for prospective memory in individuals with traumatic brain injury
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prospective memory impairment following traumatic brain injury 910 0
Condition category
Condition code
Injuries and Accidents 976 976 0 0
Brain
Physical Medicine / Rehabilitation 977 977 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this randomised controlled trial, four memory rehabilitation programmes will be compared namely 1) self-awareness training plus compensatory training, 2) self-awareness training plus remedial training, 3) placebo plus compensatory training, and 4) placebo plus remedial training. A pretest/post-test/follow-up independent-groups design will be used to compare the relative effectiveness of compensatory versus remedial rehabilitation and self-awareness training. Participants will be randomly assigned to the 4 programmes giving 25 participants in each group. Participants will have a 4-week pre-intervention period, then participate in an individual rehabilitation programme for 8 weeks (2 weeks self-awareness training or placebo plus 6 weeks compensatory or remedial training). This will enable the effects of the two components (i.e. remedial versus compensatory training and self-awareness training versus placebo) to be evaluated separately.
Intervention code [1] 594 0
None
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1297 0
To provide a comprehensive assessment of prospective memory three types of evaluation using a) psychometric testing
Timepoint [1] 1297 0
Following the 4-week baseline period, participants will be assessed on all measures by a researcher who is blind to group membership. Participants will then commence one of the 8-week standardised individual rehabilitation programmes. All programmes will be administered by the same trained researcher according to standardised, written week-by-week procedures. Post-intervention assessment using all measures will occur at the end of the programme and at a follow-up appointment arranged 6 months later.
Primary outcome [2] 1298 0
To provide a comprehensive assessment of prospective memory three types of evaluation using b) self-report and relative's report of prospective memory function
Timepoint [2] 1298 0
Following the 4-week baseline period, participants will be assessed on all measures by a researcher who is blind to group membership. Participants will then commence one of the 8-week standardised individual rehabilitation programmes. All programmes will be administered by the same trained researcher according to standardised, written week-by-week procedures. Post-intervention assessment using all measures will occur at the end of the programme and at a follow-up appointment arranged 6 months later.
Primary outcome [3] 1299 0
To provide a comprehensive assessment of prospective memory three types of evaluation using c) assessment of diary use (number and quality of diary entries)
Timepoint [3] 1299 0
Following the 4-week baseline period, participants will be assessed on all measures by a researcher who is blind to group membership. Participants will then commence one of the 8-week standardised individual rehabilitation programmes. All programmes will be administered by the same trained researcher according to standardised, written week-by-week procedures. Post-intervention assessment using all measures will occur at the end of the programme and at a follow-up appointment arranged 6 months later.
Secondary outcome [1] 2325 0
The effect of participation in each of the four prospective memory rehabilitation programmes on community integration will also be assessed using a psychosocial reintegration scale.
Timepoint [1] 2325 0
At pre-assessment, post-assessment and 6-month follow-up assessment by a researcher blind to group membership.

Eligibility
Key inclusion criteria
a) diagnosis of moderate or severe TBI b) able to communicate in English, c) ambulant or independently mobile in manual/electric wheelchair, d) has a significant other available to participate in the study, and e) gives informed consent.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) severe behavioural problems that would compromise engagement in community based rehabilitation,b) not fully emerged from coma/low level arousal/severe amnesia or confusion, c) severe communication deficits e.g. dysphasia preventing diary use, d) significant visual impairment, e) significant diagnosed premorbid psychiatric or neurological disorder, f) discharged to a residential care facility, and g) performs within the normal range on assessment of prospective memory function.

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)
One-sided numbered cards were randomly selected with sequence concealed until interventions were assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Restricted randomisation was used with blocking method. Participants were randomly allocated to one of four intervention groups through selection of one-sided numbered cards such that no group will have n + 1 participants until all other groups have n.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1074 0
Government body
Name [1] 1074 0
NHMRC grant
Country [1] 1074 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 934 0
University
Name [1] 934 0
University of Queensland,
Address [1] 934 0
Country [1] 934 0
Australia
Secondary sponsor category [2] 935 0
Hospital
Name [2] 935 0
Princess Alexandra Hospital
Address [2] 935 0
Country [2] 935 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2374 0
Griffith University
Ethics committee address [1] 2374 0
Ethics committee country [1] 2374 0
Australia
Date submitted for ethics approval [1] 2374 0
Approval date [1] 2374 0
Ethics approval number [1] 2374 0
Ethics committee name [2] 2375 0
University of Queensland
Ethics committee address [2] 2375 0
Ethics committee country [2] 2375 0
Australia
Date submitted for ethics approval [2] 2375 0
Approval date [2] 2375 0
Ethics approval number [2] 2375 0
Ethics committee name [3] 2376 0
Princess Alexandra Hospital
Ethics committee address [3] 2376 0
Ethics committee country [3] 2376 0
Australia
Date submitted for ethics approval [3] 2376 0
Approval date [3] 2376 0
Ethics approval number [3] 2376 0

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

Contacts
Principal investigator
Name 35628 0
Address 35628 0
Country 35628 0
Phone 35628 0
Fax 35628 0
Email 35628 0
Contact person for public queries
Name 9783 0
Hannah Gill
Address 9783 0
Applied Cognitive Neuroscience Research Centre
School of Psychology
Griffith University
Nathan QLD 4111
Country 9783 0
Australia
Phone 9783 0
+61 7 37353348
Fax 9783 0
+61 7 37353388
Email 9783 0
[email protected]
Contact person for scientific queries
Name 711 0
Associate Professor David Shum
Address 711 0
School of Psychology
Griffith University
Nathan QLD 4111
Country 711 0
Australia
Phone 711 0
+61 7 37353370
Fax 711 0
Email 711 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.