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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

LFU

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

Neurological

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Primary outcome [2]

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]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Primary outcome [3]

Classification of global outcomes in TBI survivors. assessed using the Glascow Outcome Scale- Extended score

Timepoint [3]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [1]

Anxiety assessed using the Hospital Anxiety and Depression Scale score

Timepoint [1]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [2]

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]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [3]

Fatigue assessed using Fatigue Severity Scale score

Timepoint [3]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [4]

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]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [5]

Change in neurological impairments assessed through multiple choice questions on follow up survey (designed specifically for this study) .

Timepoint [5]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [6]

Medication use assessed through multiple choice questions on follow up survey (designed specifically for this study) .

Timepoint [6]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [7]

Changes in family functioning issues assessed through multiple choice questions on follow up survey (designed specifically for this study).

Timepoint [7]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [8]

Changes in community resource utilisation assessed through multiple choice question on follow up survey (designed specifically for this study),

Timepoint [8]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [9]

Depression assessed using the Hospital Anxiety and Depression Scale

Timepoint [9]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [10]

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]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [11]

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]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [12]

Sexual function assessed through multiple choice questions on follow up survey (designed specifically for this study).

Timepoint [12]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [13]

Communication impairments assessed through multiple choice questions on follow up survey (designed specifically for this study).

Timepoint [13]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [14]

Relationship issues assessed through multiple choice questions on follow up survey (designed specifically for this study).

Timepoint [14]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [15]

Return to leisure activities assessed through open and multiple choice questions on follow up survey (designed specifically for this study).

Timepoint [15]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [16]

Mode of transportation used assessed through multiple choice questions on follow up survey (designed specifically for this study).

Timepoint [16]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [17]

Source of income assessed through multiple choice question on follow up survey (designed specifically for this study).

Timepoint [17]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [18]

Legal issues assessed through multiple choice question on follow up survey (designed specifically for this study).

Timepoint [18]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [19]

Experience of challenges with education/study through multiple choice question on follow up survey (designed specifically for this study).

Timepoint [19]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [20]

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]

1, 2, 3, 5, 10, 20, 30 years after traumatic brain injury date.

Secondary outcome [21]

Change in hows individual adults cope with concerns using the Coping Scale for Adults

Timepoint [21]

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]

Epworth Rehabilitation Camberwell - Camberwell

Recruitment hospital [2]

Epworth Richmond - Richmond

Recruitment postcode(s) [1]

3124 - Camberwell

Recruitment postcode(s) [2]

3121 - Richmond

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Transport Accident Commission

Address [1]

TAC
PO Box 742
Geelong, VIC 3220

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bethesda Hospital Ethics,

Ethics committee address [1]

Level 5, Leigh Place, Richmond VIC 3121

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/02/1995

Approval date [1]

01/04/1995

Ethics approval number [1]

46209

Ethics committee name [2]

Epworth Healthcare

Ethics committee address [2]

89 Bridge Rd, Richmond VIC 3121

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

03/08/2009

Approval date [2]

23/09/2009

Ethics approval number [2]

Ethics committee name [3]

Monash Health Human Research Ethics Committee

Ethics committee address [3]

Research Support Services, Monash Health Level 2, I Block, Monash Medical Centre, Clayton, VIC 3168

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

07/02/2019

Approval date [3]

21/11/2019

Ethics approval number [3]

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

Prof Jennie Ponsford

Address

Monash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street RICHMOND VIC 3121

Country

Australia

Phone

+61419320671

Fax

+61 3 9426 8925

Email

[email protected]

Contact person for public queries

Name

Meagan Carty

Address

Monash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street RICHMOND VIC 3121

Country

Australia

Phone

+613 9426 8923

Fax

+61 3 9426 8925

Email

[email protected]

Contact person for scientific queries

Name

Meagan Carty

Address

Monash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street RICHMOND VIC 3121

Country

Australia

Phone

+613 9426 8923

Fax

+61 3 9426 8925

Email

[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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
20398	Study protocol			[email protected]
20399	Informed consent form			[email protected]
20400	Ethical approval			[email protected]

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.