Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000990628
Ethics application status
Approved
Date submitted
7/08/2023
Date registered
11/09/2023
Date last updated
26/05/2024
Date data sharing statement initially provided
11/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and evaluation of the myTBI online psychoeducation platform on psychosocial adjustment to traumatic brain injury from acute to chronic injury
Scientific title
Development and evaluation of the myTBI online psychoeducation platform on psychosocial adjustment to traumatic brain injury from acute to chronic injury
Secondary ID [1] 310313 0
None
Universal Trial Number (UTN)
Trial acronym
myTBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 331030 0
Condition category
Condition code
Neurological 327827 327827 0 0
Other neurological disorders
Injuries and Accidents 327828 327828 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention name: Online psychoeducation platform (myTBI)

Intervention description: The myTBI psychoeducation platform will consist of approximately 6 (range: 4-8) brief structured modules addressing common psychosocial challenges experienced after TBI across different injury stages (acute, post-acute, chronic). Examples of psychosocial challenges that may be covered in the psychoeducation modules include understanding the diagnosis, understanding functional limitations, acceptance and coping with challenges, social connection, expectations and setting goals, and the recovery journey.

An Expert Group will determine the number and type of modules to be included in the final myTBI platform using the Delphi Expert Consensus method. The Expert Group will consist of a balanced mix of approximately 10-20 clinicians, academics, and people with lived experience with TBI from Western Australia. Expert Group members will participate in multiple rounds of online surveys in which members will be asked to anonymously rank each psychosocial challenge in order of importance until consensus on the modules to include has been achieved. Modules will be purpose-developed and include educational information, and links to relevant strategies and exercises, and other useful resources.

Who will deliver the intervention: Self-guided via online platform. Depending on level of cognitive functioning, participants will be able to work through the modules on their own, or to be guided through the modules by a rehabilitation clinician or support worker.

Mode of delivery: Online website.

Duration: 1 x 30 minute sessions, once a week for 6 weeks.

Location: Post-acute community-based rehabilitation centre or at the participant's home.
Intervention code [1] 326695 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335678 0
Mean Mayo-Portland Adaptability Inventory (MPAI-4) score
Timepoint [1] 335678 0
Pre-treatment, post-treatment (within 1 week after the final myTBI module is complete, primary timepoint), 1-month follow-up, discharge from rehabilitation.
Primary outcome [2] 335679 0
Mean Psychosocial Adjustment to Illness Scale (PAIS) score
Timepoint [2] 335679 0
Pre-treatment, post-treatment (within 1 week after the final myTBI module is complete, primary timepoint), 1-month follow-up, discharge from rehabilitation.
Primary outcome [3] 335680 0
Mean Depression, Anxiety, Stress Scale-21 (DASS-21) score
Timepoint [3] 335680 0
Pre-treatment, post-treatment (within 1 week after the final myTBI module is complete, primary timepoint), 1-month follow-up, discharge from rehabilitation.
Secondary outcome [1] 425171 0
Mean Pittsburgh Rehabilitation Participation Scale score
Timepoint [1] 425171 0
Pre-treatment, post-treatment, 1-month follow-up, discharge from rehabilitation.
Secondary outcome [2] 425172 0
Mean UK Functional Independence and Assessment Measure (UK FIM+FAM) score
Timepoint [2] 425172 0
Pre-treatment, post-treatment, 1-month follow-up, discharge from rehabilitation.
Secondary outcome [3] 425173 0
Mean Quality of life after brain injury (QoLIBRI) score
Timepoint [3] 425173 0
Pre-treatment, post-treatment, 1-month follow-up, discharge from rehabilitation.
Secondary outcome [4] 425174 0
Mean Northwick Park Dependency Score (NPDS) score
Timepoint [4] 425174 0
Pre-treatment, post-treatment, 1-month follow-up, discharge from rehabilitation.

Eligibility
Key inclusion criteria
1. Adults aged 18 years and above, AND
2. Diagnosis of TBI according to Australian Rehabilitation Outcomes Centre (AROC) impairment codes: 2.21 Traumatic brain dysfunction, open injury and 2.22 Traumatic brain dysfunction, closed injury, AND
3. Currently undergoing post-acute rehabilitation at Brightwater Care Group
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acutely ill and/or not medically stable as determined by the treating rehabilitation team, and/or;
2. In a minimally conscious state or have a prolonged disorder of consciousness (PDOC), as determined by a UK FIM+FAM score =35

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Change in primary and secondary outcomes from pre-treatment to: i) post-treatment, and ii) 1-month follow-up and ii) discharge from rehabilitation, will be evaluated using a series of multilevel mixed-effects regression analyses.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 314523 0
Hospital
Name [1] 314523 0
Perron Institute for Neurological and Translational Science
Country [1] 314523 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Brightwater Care Group
Address
Brightwater Central2A Walter Road WestInglewood WA 6052
Country
Australia
Secondary sponsor category [1] 316471 0
None
Name [1] 316471 0
Address [1] 316471 0
Country [1] 316471 0
Other collaborator category [1] 282788 0
University
Name [1] 282788 0
The University of Western Australia
Address [1] 282788 0
35 Stirling Highway, CRAWLEY Western Australia 6009
Country [1] 282788 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313565 0
North Metropolitan Health Service Mental Health Research Ethics and Governance Office
Ethics committee address [1] 313565 0
Ethics committee country [1] 313565 0
Australia
Date submitted for ethics approval [1] 313565 0
Approval date [1] 313565 0
09/05/2023
Ethics approval number [1] 313565 0
RGS0000005877

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128566 0
Dr Lakkhina Troeung
Address 128566 0
Brightwater Central 2A Walter Road WestInglewood WA 6052
Country 128566 0
Australia
Phone 128566 0
+61 8 9202 2800
Fax 128566 0
Email 128566 0
[email protected]
Contact person for public queries
Name 128567 0
Lakkhina Troeung
Address 128567 0
Brightwater Central 2A Walter Road WestInglewood WA 6052
Country 128567 0
Australia
Phone 128567 0
+61 8 9202 2800
Fax 128567 0
Email 128567 0
[email protected]
Contact person for scientific queries
Name 128568 0
Lakkhina Troeung
Address 128568 0
Brightwater Central 2A Walter Road WestInglewood WA 6052
Country 128568 0
Australia
Phone 128568 0
+61 8 9202 2800
Fax 128568 0
Email 128568 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
Individual participant data will not be made publicly available due to organisational policies.


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.