Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001347752p
Ethics application status
Submitted, not yet approved
Date submitted
29/09/2022
Date registered
19/10/2022
Date last updated
2/06/2024
Date data sharing statement initially provided
19/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effectiveness of a vocational rehabilitation (VR) smartphone application (app) to support return to work (RTW) after Traumatic brain injury (TBI)
Scientific title
Investigating the effectiveness of a vocational rehabilitation (VR) smartphone application (app) to support return to work (RTW) after Traumatic brain injury (TBI)
Secondary ID [1] 307915 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 327561 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324652 324652 0 0
Occupational therapy
Neurological 324887 324887 0 0
Other neurological disorders
Injuries and Accidents 324888 324888 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment consists of access and unconditional use of a psychoeducational smartphone app to support the return to work (RTW) of individuals with TBI; the RTW after TBI App. The app contains a written chronological guide to the different stages of RTW following TBI and includes the following modules: Contemplating RTW, Preparing for RTW, At Work, At Home, and Support. These modules contain TBI specific, practical information to help plan for returning to work and information on common difficulties and barriers when returning to employment. The modules also include strategies and advice to manage common challenges. The final module is
Videos/Stories and this module includes video interviews with individuals with TBI with living experience of RTW sharing their RTW experiences and offering advice and strategies to overcome limitations). The app uses written, audio and video modes, all written content also has an audio 'text to voice' function that can speak the written content aloud by clicking the audio button. The app has been co-designed with individual with TBI with living experience of returning to work and the information contained in the app is based on extensive research done by the TBI and rehabilitation expert researchers and clinicians who developed the app.

The usage of each participant will be monitored (frequency and duration) will be monitored through app analytics.

Participants will be provided with instructions on how to download the app to their phones (phone guidance is provided by the study co-ordinator for those who prefer to be guided through the download process or those who have difficulty with the instructions). They will then be given a short 15 minute presentation/guide to the app by their RTW/vocational provider and asked to use the app at their leisure - the amount of time participants will spend using the app will vary highly, but is anticipated to be up to 10 hours over a period of several months while participants are returning to work.
Intervention code [1] 324376 0
Treatment: Other
Intervention code [2] 324377 0
Rehabilitation
Comparator / control treatment
The standard care group will receive the same relevant rehabilitation therapy sessions such as physiotherapy, occupational therapy, speech pathology and neuropsychology as the treatment group. Therapy goals may include addressing issues that will lead to achievement of vocational goals (such as attending a work conditioning group or a gym program to improve endurance) however participants in the treatment as usual group won’t receive the additional targeted vocational rehabilitation or a peer support/lived experience intervention that the RTWapp provides.
Once referred to a vocational provider, participants in the standard care group will receive the usual education or preparation provided during sessions with their vocational provider which will be limited by the knowledge and experience of their provider and may also include any resources material provided by their provider. Those in the RTW app group will be able to access a wide range of vocational information and lived experience videos, at any time while they are preparing for RTW and once back at work.
Control group
Active

Outcomes
Primary outcome [1] 332468 0
Employment status (mean weekly hours in paid employment) at six months after downloading the app. This data will be collected using a study-specific questionnaire.
Timepoint [1] 332468 0
6 months after downloading the app.
Secondary outcome [1] 413643 0
Time taken to RTW. This data will be collected using a study-specific questionnaire.
Timepoint [1] 413643 0
6 months after downloading the app.
Secondary outcome [2] 414239 0
Hours of vocational rehabilitation intervention. This data will be collected from RTW/VR provider participants using a study-specific questionnaire (when RTW/VR providers sign up to participate in the trial, they will be asked to record hrs of intervention provided to each of their clients with TBI who are participants in the trial).
Timepoint [2] 414239 0
6 months after downloading the app.
Secondary outcome [3] 414240 0
Quality of life measured on the SF-12 Health Survey
Timepoint [3] 414240 0
6 months after downloading the app

Eligibility
Key inclusion criteria
Individuals with traumatic brain injury (TBI) who were employed prior to injury.
RTW/VR providers who have experience working with individuals with TBI (these participants will be the healthy individuals who are eligible to participate).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Following appropriate exploratory analysis of the data, comparison of the two groups, RTW app group versus standard vocational intervention only, on the primary outcome of mean weekly hours in paid employment at six months will be performed using linear regression. Secondary outcomes such as time to RTW, hours of vocational provider intervention and SF-12 Health Survey physical and mental health summary scores will also be compared using linear regression, or if data are found to be skewed, appropriate methods for skewed data such as quantile regression or negative binomial regression, appropriate for the analysis of counts, including number of hours worked. A small number of clinically relevant variables, such as age, gender, number of hours worked prior to injury, education, injury type and severity, will be included in the regression models as potential predictors and confounders.
Descriptive statistics including means, standard deviations for continuous data (medians and interquartile ranges or the difference between the 25th and 75 percentiles if found to be skewed), and frequencies and percentages for binary and categorical data will be presented, along with appropriate graphs. 95% confidence intervals will be presented throughout. All statistical analyses will be conducted by, or under direct supervision of, a professional biostatistician, who is blinded to group assignment, employing a standard statistical package such as Stata 15 or higher.
Qualitative interviews for each data source (i.e. individuals with TBI and vocational providers) will be transcribed and then analysed thematically following the six-step process recommended by Braun & Clarke.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
30/12/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312188 0
Government body
Name [1] 312188 0
Trasport Accident Commission (TAC)
Country [1] 312188 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellinton Road
Clayton
VIC 3800
Country
Australia
Secondary sponsor category [1] 313883 0
None
Name [1] 313883 0
Address [1] 313883 0
Country [1] 313883 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311575 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 311575 0
Monash University
Wellington Road
Clayton VIC 3800
Ethics committee country [1] 311575 0
Australia
Date submitted for ethics approval [1] 311575 0
18/10/2022
Approval date [1] 311575 0
Ethics approval number [1] 311575 0

Summary
Brief summary
An APP has been developed to provide information and guidance to individuals with TBI and RTW/VR providers in ways to prepare for returning to work and to provide strategies to manage potential challenges once back at work. The aim of the project is to compare the effectiveness of the app in improving employment outcomes in a group who access the app prior to and during their return to work as compared with those who don’t. The results will be used to justify use of the app to improve work outcomes for individuals after TBI.
Trial website
Trial related presentations / publications
Public notes
Development and feasibility testing of a psychoeducational tool to support the return to work (RTW) of individuals with traumatic brain injury (TBI): The RTW after TBI app
Libeson, Lauren ; Ross, Pamela ; Downing, Marina ; Ponsford, Jennie
Neuropsychological rehabilitation, 2022, Vol.ahead-of-print (ahead-of-print), p.1-19

Contacts
Principal investigator
Name 121578 0
Dr Pamela Ross
Address 121578 0
Epworth Healthcare
89 Bridge Road
Richmond
VIC 3121
Country 121578 0
Australia
Phone 121578 0
+61 03 9426 8745
Fax 121578 0
+61 03 9426 8734
Email 121578 0
Pamela.Ross@epworth.org.au
Contact person for public queries
Name 121579 0
Dr Lauren Libeson
Address 121579 0
Monash University
Wellington Road
Clayton VIC 3800
Australia
Country 121579 0
Australia
Phone 121579 0
+61 408 471 975
Fax 121579 0
Email 121579 0
lauren.libeson@monash.edu
Contact person for scientific queries
Name 121580 0
Dr Lauren Libeson
Address 121580 0
Monash University
Wellington Road
Clayton VIC 3800
Australia
Country 121580 0
Australia
Phone 121580 0
+61 408 471 975
Fax 121580 0
Email 121580 0
lauren.libeson@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be available in data dictionaries. We do not have ethical approval for this.


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.