Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001539325
Ethics application status
Approved
Date submitted
21/10/2017
Date registered
7/11/2017
Date last updated
7/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of a standardised assessment tool (Systematic Assessment for Brain Injury Rehabilitation) for patients after a traumatic brain injury of and its correlation with functional outcome measures
Scientific title
Development of a standardised assessment tool (Systematic Assessment for Brain Injury Rehabilitation) for patients after a traumatic brain injury of and its correlation with functional outcome measures
Secondary ID [1] 293180 0
Nil known
Universal Trial Number (UTN)
U1111-1204-0768
Trial acronym
SABIR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 305173 0
Cognitive Impairment 305174 0
Condition category
Condition code
Neurological 304490 304490 0 0
Other neurological disorders
Injuries and Accidents 304533 304533 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baseline brief cognitive assessments with Addenbrooke's Cognitive Examination-III, Montreal Cognitive Assessment, Reliable Digit Span, oral Trail Making Test-B were undertaken by MD Project Medical students on participants who were inpatients in Brain Injury Service or were referred for follow up in Brain Injury Outpatient Clinic. The baseline cognitive assessments were undertaken in a single session either in the outpatient department or in hospital. The baseline assessments are estimated to take 45 minutes in duration and are all undertaken on the same day.

All participants were invited to undergo a formal neuropsychological test battery, estimated to take 60 minutes, were administered as close to the baseline cognitive screen as possible. The neuropsychological assessment was undertaken in a single session as close to the timing of the baseline cognitive assessment as possible in the hospital or outpatient setting. A trained neurospychologist attached to Brain Injury Unit or University of New South Wales were the designated neurospychologists.
Intervention code [1] 299433 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303727 0
Functional Outcomes with Mayo-Portland Assessment Inventory-4
Timepoint [1] 303727 0
Baseline assessment within 6 months of initial brain injury and follow up to 3 months following baseline assessment
Primary outcome [2] 303806 0
Assessment of accuracy and validity of Addenbrooke's Cognitive Assessment as compared with neuropsychological assessment
Timepoint [2] 303806 0
Up to 3 months following initial baseline cognitive testing
Primary outcome [3] 303807 0
Assess how Addenbrooke's Cognitive Assessment correlates with Montreal Cognitive Assessment
Timepoint [3] 303807 0
At initial baseline cognitive screening
Secondary outcome [1] 339979 0
Functional Independence Measure
Timepoint [1] 339979 0
Baseline between 2 weeks and 6 months following brain injury and follow up within 3 months of baseline assessment
Secondary outcome [2] 340280 0
Assessment of accuracy and validity of Montreal Cognitive Assessment as compared with neuropsychological assessment
Timepoint [2] 340280 0
Up to 3 months following initial baseline cognitive testing
Secondary outcome [3] 340281 0
Assessment of accuracy and validity of oral Trail Making Test-B as compared with neuropsychological assessment
Timepoint [3] 340281 0
Up to 3 months following initial baseline cognitive testing
Secondary outcome [4] 340282 0
Assessment of accuracy and validity of Reliable Digit Span as compared with neuropsychological assessment
Timepoint [4] 340282 0
Up to 3 months following initial baseline cognitive testing

Eligibility
Key inclusion criteria
Aged over 18-65 years of age, able to consent; were within 6 months of a new traumatic brain injury of sufficient severity to require referral to Brain Injury Outpatient Clinic or admission to Brain Injury Unit for inpatient rehabilitation. A TBI is defined as documented injury with abnormal GCS at scene or A&E, a measurable PTA of any duration or abnormal new findings on CT/MRI
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to consent
Severe language impairments

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)
No concealment, all participants received same screening assessments
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Correlation statistics
Multiple regression
ROC

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/02/2016
Date of last participant enrolment
Anticipated
Actual
30/03/2017
Date of last data collection
Anticipated
Actual
30/06/2017
Sample size
Target
40
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9220 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment hospital [2] 9221 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 17876 0
2112 - Ryde
Recruitment postcode(s) [2] 17877 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 297810 0
Hospital
Name [1] 297810 0
Royal Rehab
Country [1] 297810 0
Australia
Primary sponsor type
Hospital
Name
Royal Rehab
Address
c/o 235 Morrison Rd Ryde NSW Australia 2112
Country
Australia
Secondary sponsor category [1] 296852 0
None
Name [1] 296852 0
Not applicable
Address [1] 296852 0
Not applicable
Country [1] 296852 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298867 0
NSLHD Human Research Ethics Committee
Ethics committee address [1] 298867 0
NSLHD Research Office
Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW Australia 2065
Ethics committee country [1] 298867 0
Australia
Date submitted for ethics approval [1] 298867 0
03/09/2015
Approval date [1] 298867 0
02/12/2015
Ethics approval number [1] 298867 0
RESP/15/291

Summary
Brief summary
The purpose of this study is to determine whether baseline cognitive screening tests, Montreal Cognitive Assessment (MoCA), Addenbrooke’s Cognitive Assessment-III (ACE-III), Oral Trail Making Test-B (oTMT-B), reliable Digit Span predict functional outcomes in patients following a traumatic brain injury and whether they correlate with neuropsychological testing. In addition, the study aimed to determine the accuracy and validity of baseline cognitive screening tests in the detection of those patients with cognitive impairment on neuropsychological testing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78490 0
Dr Tram Bui
Address 78490 0
c/o Royal Rehab
235 Morrison Rd Ryde NSW 2112
Country 78490 0
Australia
Phone 78490 0
+61 2 98089222
Fax 78490 0
Email 78490 0
[email protected]
Contact person for public queries
Name 78491 0
Tram Bui
Address 78491 0
c/o Royal Rehab
235 Morrison Rd Ryde NSW 2112
Country 78491 0
Australia
Phone 78491 0
+61 2 98089222
Fax 78491 0
Email 78491 0
[email protected]
Contact person for scientific queries
Name 78492 0
Tram Bui
Address 78492 0
c/o Royal Rehab
235 Morrison Rd Ryde NSW 2112
Country 78492 0
Australia
Phone 78492 0
+61 2 98089222
Fax 78492 0
Email 78492 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.