Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000433202
Ethics application status
Approved
Date submitted
26/05/2009
Date registered
10/06/2009
Date last updated
9/02/2021
Date data sharing statement initially provided
9/02/2021
Date results information initially provided
9/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Goals and self regulation skills in brain injury rehabilitation: a Randomised Clinical Trial
Scientific title
Randomised clinical trial to determine the inpact on health and functionning of a novel intervention to improve goal related activity and self regulation compared with use of the Goal Attainment Scaling measurement tool and usual practice in people with moderate to severe traumatic brain injury.
Universal Trial Number (UTN)
Trial acronym
Goals -TBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 4855 0
Condition category
Condition code
Injuries and Accidents 237204 237204 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) a novel intervention aiming to improve goal related activity and self regulation skills (goals-SR). The intervention uses components of both Identity Oriented Goal Training and Goal Management Training. Deliverred weekly for 8 weeks during intervention sessions lasting aproximately one hour.
b) Goal Attainment Scaling (GAS) measurement tool, administerred weekly over an 8 week period during intervention sessions lasting aproximately one hour.
c) usual practice (ie participants will recieve no additional intervention from the researchers. They will continue with their planned rehabilitation process, details of which will be collected at the end of the study period. There is currently no standard practice)
Intervention code [1] 236639 0
Rehabilitation
Comparator / control treatment
This study uses a factorial design looking at separate and interactive effects of the interventions a and b above, and comparing to 'usual practice'
Control group
Active

Outcomes
Primary outcome [1] 238015 0
Goal related skills (as measured by Self-Regulatory Skills Interview)
Timepoint [1] 238015 0
Immediately post intervention, 3 months post intervention, 12 months post intervention.
Primary outcome [2] 238016 0
mood and behaviour (measured by self and carer report on Neurobehavioural Functionning Inventory
Timepoint [2] 238016 0
Immediately post intervention, 3 months post intervention, 12 months post
Secondary outcome [1] 242158 0
progress towards achieving meaningful goals in participant's life (measured by schedule for evaluation of individual quality of life - direct weighting (SEIQol-DW))
Timepoint [1] 242158 0
Immediately post intervention, 3 months post intervention, 12 months post
Secondary outcome [2] 242159 0
Social integration, carer burden and well being (assessed by questionnaire)
Timepoint [2] 242159 0
Immediately post intervention, 3 months post intervention, 12 months post

Eligibility
Key inclusion criteria
All patients/clients on the Accident Compensation Corporation (ACC) national database who have had moderate or severe traumatic brain injury (TBI) in the Auckland and Wellington regions will be eligible for recruitment if they meet the following inclusion criteria: a) a history of Post Traumatic Amnesia = 1 hour b) moderate disability on the Extended Glasgow Outcome Scale c) received compensation for 12 weeks (indicating resultant disability) d) are 6 to 18 months post injury.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Persistent coma (Glasogow Coma Score (GCS) on screening of = 8 and/or persistent post traumatic amnesia) b) not able to demonstrate a basic level of intellectual awareness on screening c) are unable to communicate with the researcher and/or intervention team involved in the study (all efforts will be made to offer interpreter services) d) unstable medical health precluding participation in rehabilitation.

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)
Once eligibility criteria including consent have been obtained by teh assessing researchers a randomisation request is faxed to teh central data manager who allocates the next randomisation number and associated treatment group from the pre determined randomisation lists, and faxes this information to the INTERVENTION researcher who is tehn responsible for administerring the intervention. The ASSESSING Researchers are not informed of the allocation, and teh randomisation lists are accessible only to teh central data manager and study statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/02/2009
Actual
24/02/2009
Date of last participant enrolment
Anticipated
Actual
15/12/2011
Date of last data collection
Anticipated
Actual
15/12/2012
Sample size
Target
180
Accrual to date
Final
110
Recruitment outside Australia
Country [1] 1808 0
New Zealand
State/province [1] 1808 0

Funding & Sponsors
Funding source category [1] 5020 0
Government body
Name [1] 5020 0
Health Research Council (New Zealand)
Country [1] 5020 0
New Zealand
Primary sponsor type
University
Name
AUT University
Address
Person Centred Reahabilitation Research Team (PCRrt), School of Rehabilitation and Occupation Studies, Akoranga Drive Campus, Private Bag 92006, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 4539 0
University
Name [1] 4539 0
Otago University
Address [1] 4539 0
Wellington School of Medicine, 23 Mein Street, Newtown, Wellington 6021
Country [1] 4539 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7118 0
New Zealand Heath & Disability Ethics Committee - Multi Region
Ethics committee address [1] 7118 0
c/- Ministry of Health
133 Molesworth St
Wellington
Ethics committee country [1] 7118 0
Date submitted for ethics approval [1] 7118 0
28/08/2008
Approval date [1] 7118 0
24/02/2009
Ethics approval number [1] 7118 0
MEC/08/09/115

Summary
Brief summary
Our objective is to determine effective strategies to improve goal related activity for people with traumatic brain injury (TBI). Goal setting is a key rehabilitation strategy for promoting recovery and adaptation. However, clinical practice is variable, outcomes uncertain, and both patients and professionals find the process frustrating.
We recently completed an HRC-funded feasibility study examining two novel approaches to goal setting. Practical and methodological factors were identified and are addressed in the definitive trial proposed here.
This Randomised Clinical Trial will determine the impact on health and functioning of:
a) a novel intervention aiming to improve goal related activity and self regulation skills (Goals-SR) compared with
b) use of Goal Attainment Scaling (GAS), a measurement tool and
c) usual practice
This study will identify strategies that are most successful at improving goal related activity. This outcome will benefit the person with TBI (improved functioning, motivation, mood) and reduce carer burden.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29648 0
Address 29648 0
Country 29648 0
Phone 29648 0
Fax 29648 0
Email 29648 0
Contact person for public queries
Name 12895 0
Professor Kathryn McPherson
Address 12895 0
Person Centred Rehabilitation Research Team (PCRrt), School of Rehabilitation and Occupation Studies, Akoranga Drvie Campus, Private Bag 92006, Auckland 1142
Country 12895 0
New Zealand
Phone 12895 0
+64 9 921 9999 ext 7110
Fax 12895 0
+64 9 921 9620
Email 12895 0
[email protected]
Contact person for scientific queries
Name 3823 0
Professor Kathryn McPherson
Address 3823 0
Person Centred Rehabilitation Research Team (PCRrt), School of Rehabilitation and Occupation Studies, Akoranga Drvie Campus, Private Bag 92006, Auckland 1142
Country 3823 0
New Zealand
Phone 3823 0
+64 9 921 9999 ext 7110
Fax 3823 0
+64 9 921 9620
Email 3823 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseMeasuring neurobehavioral functioning in people with traumatic brain injury: Rasch analysis of neurobehavioral functioning inventory.2016https://dx.doi.org/10.1097/HTR.0000000000000170
N.B. These documents automatically identified may not have been verified by the study sponsor.