Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001267640
Ethics application status
Approved
Date submitted
27/09/2023
Date registered
6/12/2023
Date last updated
6/12/2023
Date data sharing statement initially provided
6/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Longitudinal Head Injury Outcome Study
Scientific title
Longitudinal Head Injury Outcome Study of Long-term physical, mental and participation outcomes in adults after traumatic brain injury.
Secondary ID [1] 310535 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LFU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
traumatic brain injury 331352 0
Condition category
Condition code
Injuries and Accidents 328102 328102 0 0
Other injuries and accidents
Neurological 328533 328533 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
30
Target follow-up type
Years
Description of intervention(s) / exposure
Observing long-term outcome (up to 30 years) of individuals with mild to severe traumatic brain injury, in terms of mobility, independence in daily activities, participation in work, study, leisure activities and relationships, psychosocial functioning and self-reported cognitive and behavioural changes through follow-up quantitative questionnaires completed over the phone at each time point of 1, 2, 3, 5, 10, 20, 30 years post traumatic brain injury date.
Intervention code [1] 326927 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335979 0
Level of mobility assessed through multiple choice question on follow up survey (designed specifically for this study) completed over the phone at each time point.
Timepoint [1] 335979 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Primary outcome [2] 335980 0
Level of independence with daily activities assessed through multiple choice questions on follow up survey (designed specifically for this study) completed over the phone at each time point.
Timepoint [2] 335980 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Primary outcome [3] 335981 0
Classification of global outcomes in TBI survivors. assessed using the Glascow Outcome Scale- Extended score
Timepoint [3] 335981 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [1] 426331 0
Anxiety assessed using the Hospital Anxiety and Depression Scale score
Timepoint [1] 426331 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [2] 426332 0
Changes in cognitive function assessed through a multiple choice question on follow up survey (designed specifically for this study) completed over the phone at each time point.
Timepoint [2] 426332 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [3] 426335 0
Fatigue assessed using Fatigue Severity Scale score
Timepoint [3] 426335 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [4] 426336 0
Employment status assessed through multiple choice questions and free text on follow up survey (designed specifically for this study) at each follow up time point.
Timepoint [4] 426336 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [5] 426337 0
Change in neurological impairments assessed through multiple choice questions on follow up survey (designed specifically for this study) .
Timepoint [5] 426337 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [6] 426338 0
Medication use assessed through multiple choice questions on follow up survey (designed specifically for this study) .
Timepoint [6] 426338 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [7] 426339 0
Changes in family functioning issues assessed through multiple choice questions on follow up survey (designed specifically for this study).
Timepoint [7] 426339 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [8] 426340 0
Changes in community resource utilisation assessed through multiple choice question on follow up survey (designed specifically for this study),
Timepoint [8] 426340 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [9] 427959 0
Depression assessed using the Hospital Anxiety and Depression Scale
Timepoint [9] 427959 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [10] 427984 0
Changes in behavioural function assessed through a multiple choice question on follow up quantitative questionnaire (designed specifically for this study) completed over the phone at each time point.
Timepoint [10] 427984 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [11] 427985 0
Experience of challenges at work for those who had returned to work post injury assessed through open and multiple choice questions on follow up survey (designed specifically for this study).
Timepoint [11] 427985 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [12] 427986 0
Sexual function assessed through multiple choice questions on follow up survey (designed specifically for this study).
Timepoint [12] 427986 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [13] 427987 0
Communication impairments assessed through multiple choice questions on follow up survey (designed specifically for this study).
Timepoint [13] 427987 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [14] 427988 0
Relationship issues assessed through multiple choice questions on follow up survey (designed specifically for this study).
Timepoint [14] 427988 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [15] 427989 0
Return to leisure activities assessed through open and multiple choice questions on follow up survey (designed specifically for this study).
Timepoint [15] 427989 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [16] 427990 0
Mode of transportation used assessed through multiple choice questions on follow up survey (designed specifically for this study).
Timepoint [16] 427990 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [17] 428866 0
Source of income assessed through multiple choice question on follow up survey (designed specifically for this study).
Timepoint [17] 428866 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [18] 428867 0
Legal issues assessed through multiple choice question on follow up survey (designed specifically for this study).
Timepoint [18] 428867 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [19] 428868 0
Experience of challenges with education/study through multiple choice question on follow up survey (designed specifically for this study).
Timepoint [19] 428868 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [20] 428869 0
Study status assessed through multiple choice questions and free text on follow up survey (designed specifically for this study) at each follow up time point.
Timepoint [20] 428869 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.
Secondary outcome [21] 428870 0
Change in hows individual adults cope with concerns using the Coping Scale for Adults
Timepoint [21] 428870 0
1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Eligibility
Key inclusion criteria
Participants are included if they:
have been admitted to Epworth Richmond or Camberwell for rehabilitation following a traumatic brain injury of any severity
are over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Inadequate English capability to complete study measures
• Inadequate cognitive capability to complete study measures
• Impairments, functional limitations, and symptoms that affect CIP outcome not primarily due to TBI

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Many different methods are used to analyse data as appropriate to the dataset and goals of analysis, ranging from simple frequency statistics to multi-level modelling or structural equation modelling.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/1988
Date of last participant enrolment
Anticipated
31/12/2033
Actual
Date of last data collection
Anticipated
31/12/2063
Actual
Sample size
Target
7000
Accrual to date
3264
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25498 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment hospital [2] 25499 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 41310 0
3121 - Richmond
Recruitment postcode(s) [2] 41309 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 314736 0
Government body
Name [1] 314736 0
Transport Accident Commission
Country [1] 314736 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Monash Epworth Rehabilitation Research Centre
Address
Ground Floor
185-187 Hoddle Street
RICHMOND VIC 3121
Country
Australia
Secondary sponsor category [1] 316742 0
None
Name [1] 316742 0
Address [1] 316742 0
Country [1] 316742 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313746 0
Bethesda Hospital Ethics,
Ethics committee address [1] 313746 0
Level 5, Leigh Place, Richmond VIC 3121
Ethics committee country [1] 313746 0
Australia
Date submitted for ethics approval [1] 313746 0
01/02/1995
Approval date [1] 313746 0
01/04/1995
Ethics approval number [1] 313746 0
46209
Ethics committee name [2] 313767 0
Epworth Healthcare
Ethics committee address [2] 313767 0
89 Bridge Rd, Richmond VIC 3121
Ethics committee country [2] 313767 0
Australia
Date submitted for ethics approval [2] 313767 0
03/08/2009
Approval date [2] 313767 0
23/09/2009
Ethics approval number [2] 313767 0
Ethics committee name [3] 313791 0
Monash Health Human Research Ethics Committee
Ethics committee address [3] 313791 0
Research Support Services, Monash Health Level 2, I Block, Monash Medical Centre, Clayton, VIC 3168
Ethics committee country [3] 313791 0
Australia
Date submitted for ethics approval [3] 313791 0
07/02/2019
Approval date [3] 313791 0
21/11/2019
Ethics approval number [3] 313791 0

Summary
Brief summary
The Longitudinal Head Injury Outcome Project is a long-standing research project investigating the functional, cognitive, behavioural and physical and emotional outcomes of patients who have sustained a TBI from the time of injury up to 30 years after their injury. This study aims to provide comprehensive information regarding the difficulties experienced by these individuals and their families over long periods of time after injury. This information can be used to establish the needs of individuals with TBI, identify predictors of outcome, develop rehabilitation programs to improve outcome, inform TAC policy and provide ongoing service to TBI patients.
Trial website
Trial related presentations / publications
Public notes
Recruitment commenced prior to ethics approval as no ethics committee existed at Bethesda hospital (now Epworth Rehabilitation, Richmond) at the time the study started. The study started as a quality improvement exercise to monitor patient outcomes post head injury. Patient consent was always sought at recruitment and all the guidelines that were ultimately approved once the ethics committee was formed at Epworth were adhered to at commencement of the project. Once an ethics committee was formed at Epworth, ethical approval was gained.

Contacts
Principal investigator
Name 129222 0
Prof Jennie Ponsford
Address 129222 0
Monash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street RICHMOND VIC 3121
Country 129222 0
Australia
Phone 129222 0
+61419320671
Fax 129222 0
+61 3 9426 8925
Email 129222 0
jennie.ponsford@monash.edu
Contact person for public queries
Name 129223 0
Ms Meagan Carty
Address 129223 0
Monash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street RICHMOND VIC 3121
Country 129223 0
Australia
Phone 129223 0
+613 9426 8923
Fax 129223 0
+61 3 9426 8925
Email 129223 0
Meagan.Carty@epworth.org.au
Contact person for scientific queries
Name 129224 0
Ms Meagan Carty
Address 129224 0
Monash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street RICHMOND VIC 3121
Country 129224 0
Australia
Phone 129224 0
+613 9426 8923
Fax 129224 0
+61 3 9426 8925
Email 129224 0
Meagan.Carty@epworth.org.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20398Study protocol  Meagan.Carty@epworth.org.au
20399Informed consent form  Meagan.Carty@epworth.org.au
20400Ethical approval  Meagan.Carty@epworth.org.au



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.