Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000461291
Ethics application status
Not yet submitted
Date submitted
23/05/2009
Date registered
16/06/2009
Date last updated
16/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A Personal Digital Assistant to Augment Goal Management Training for Traumatic Brain Injury Patients
Scientific title
The Acceptability of Goal Management Training for Short Term Memory Loss in Traumatic Brain Injury patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Short term memory loss as a result of Traumatic Brain Injury 4831 0
Condition category
Condition code
Neurological 237173 237173 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Goal Management Training. Briefly, in this instance, the training involves one hour sessions once per week over a period of three weeks. The training is conducted with the clinician using the personal digital assistant to set the goals and their relevant tasks. The patients then use these programmed tasks in their training.
Intervention code [1] 4609 0
Rehabilitation
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 237991 0
Acceptability using a pre and post task questionnaire as well as semi-structured interview.
Timepoint [1] 237991 0
at baseline and at 12 weeks after intervention commencement.
Secondary outcome [1] 242122 0
Effectiveness using a pre and post task questionnaire as well as a semi-structured interview.
Timepoint [1] 242122 0
at 1 week after intervention commencement

Eligibility
Key inclusion criteria
Within 6 months of sustaining a Traumatic Brain Injury and undergoing rehabilitation.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
In patient.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 5007 0
Government body
Name [1] 5007 0
Health Research Council of New Zealand
Country [1] 5007 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
ABI Rehabilitation
Address
ABI Rehabilitation Management Ltd

180 Metcalfe Road Ranui 0612
Country
New Zealand
Secondary sponsor category [1] 4527 0
Government body
Name [1] 4527 0
School of Computing and Mathematical Sciences
Address [1] 4527 0
Auckland Univeristy of Technology
Private bag 92006
Auckland 1010
Country [1] 4527 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 7109 0
Ethics committee address [1] 7109 0
Ethics committee country [1] 7109 0
Date submitted for ethics approval [1] 7109 0
08/08/2009
Approval date [1] 7109 0
Ethics approval number [1] 7109 0

Summary
Brief summary
Goal setting is a core strategy in rehabilitation. However, engagement in goal related processes is complex and difficult for people with traumatic brain injury (TBI). Interventions to prevent ‘goal failure’ are urgently required.


The aim of this study is to test the utility and acceptability of a Goal Management Training Personal Device (GMT-PD). In the first phase, six healthy participants evaluate the device. In the second phase, six TBI sufferers evaluate it. Observational, interview and questionnaire data will be collated to explore the utility, functionality and acceptability of the GMT-PD.


Novel goal management strategies appear to have potential to facilitate goal directed behaviour and enhance the self regulation skills, thereby improving mood, motivation and a sense of self. Given that rehabilitation resources are limited, it is crucial we find new ways to enable people to learn and practice these skills that are so impacted on by brain injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29630 0
Address 29630 0
Country 29630 0
Phone 29630 0
Fax 29630 0
Email 29630 0
Contact person for public queries
Name 12877 0
Dr Judith Symonds
Address 12877 0
School of Computing and Mathematical Science
AUT University
Private Bag 92006
Auckland 1010
Country 12877 0
New Zealand
Phone 12877 0
0064 9 921 9999 x5879
Fax 12877 0
Email 12877 0
[email protected]
Contact person for scientific queries
Name 3805 0
Dr Judith Symonds
Address 3805 0
School of Computing and Mathematical Sciences
AUT University
Private Bag 92006
Auckland 1010
Country 3805 0
New Zealand
Phone 3805 0
006 9 921 9999 x5879
Fax 3805 0
Email 3805 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.