ANZCTR - Registration

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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

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

Condition category

Condition code

Injuries and Accidents

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]

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]

Goal related skills (as measured by Self-Regulatory Skills Interview)

Timepoint [1]

Immediately post intervention, 3 months post intervention, 12 months post intervention.

Primary outcome [2]

mood and behaviour (measured by self and carer report on Neurobehavioural Functionning Inventory

Timepoint [2]

Immediately post intervention, 3 months post intervention, 12 months post

Secondary outcome [1]

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]

Immediately post intervention, 3 months post intervention, 12 months post

Secondary outcome [2]

Social integration, carer burden and well being (assessed by questionnaire)

Timepoint [2]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council (New Zealand)

Address [1]

Level 3, 110 Stanley Street, Auckland, 1010

Country [1]

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]

University

Name [1]

Otago University

Address [1]

Wellington School of Medicine, 23 Mein Street, Newtown, Wellington 6021

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

New Zealand Heath & Disability Ethics Committee - Multi Region

Ethics committee address [1]

c/- Ministry of Health 
133 Molesworth St 
Wellington

Ethics committee country [1]

Date submitted for ethics approval [1]

28/08/2008

Approval date [1]

24/02/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Kathryn McPherson

Address

Person Centred Rehabilitation Research Team (PCRrt), School of Rehabilitation and Occupation Studies, Akoranga Drvie Campus, Private Bag 92006, Auckland 1142

Country

New Zealand

Phone

+64 9 921 9999 ext 7110

Fax

+64 9 921 9620

katmcphe@aut.ac.nz

Contact person for scientific queries

Name

Professor Kathryn McPherson

Address

Person Centred Rehabilitation Research Team (PCRrt), School of Rehabilitation and Occupation Studies, Akoranga Drvie Campus, Private Bag 92006, Auckland 1142

Country

New Zealand

Phone

+64 9 921 9999 ext 7110

Fax

+64 9 921 9620

katmcphe@aut.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Measuring neurobehavioral functioning in people with traumatic brain injury: Rasch analysis of neurobehavioral functioning inventory.	2016	https://dx.doi.org/10.1097/HTR.0000000000000170

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically