Trial Review

Please note that the ANZCTR will be unattended on Friday 25th April due to the ANZAC Day public holiday. Submissions and updates will not be processed during that time.

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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
ACTRN12625000306415
Ethics application status
Approved
Date submitted
3/04/2025
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing a Co-Design Project to Enhance Sexuality Support for Individuals with Traumatic Brain Injury
Scientific title
Evaluating a Co-Design and Implementation Project to Improve Sexuality Support Following Traumatic Brain Injury in a Multi-Disciplinary Rehabilitation Unit
Secondary ID [1] 314030 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This current study is a follow-up study to a previous study previously registered with ANZCTR - record ACTRN12622001033730

Health condition
Health condition(s) or problem(s) studied:
traumatic brain injury 336772 0
Condition category
Condition code
Physical Medicine / Rehabilitation 333259 333259 0 0
Other physical medicine / rehabilitation
Neurological 333260 333260 0 0
Other neurological disorders
Injuries and Accidents 333261 333261 0 0
Other injuries and accidents
Public Health 333262 333262 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The clinician co-designed intervention consists of a staff e-learning module and other relevant clinician and patient-facing resources (e.g., trifold patient brochure, modified case conference team meeting form, and clinician-directed infographic) on the topic of sexuality after Traumatic Brain Injury (TBI).

The goal of the intervention is to improve sexuality support for patients at the Epworth acquired brain injury (ABI) rehabilitation unit such that clinicians will attempt to address sexuality with patients on a routine basis. The e-learning module is anticipated to take 30 minutes to complete and will touch on topics including foundational knowledge of sexuality and practical information on how to address sexuality within the Epworth acquired brain injury (ABI) rehabilitation unit. The mode of information delivery used in the module will primarily be in the text form and interactive activities with text. Short videos and animated videos may be used.

This staff e-learning module was co-designed through earlier focus group sessions with clinicians working at the ABI rehabilitation unit and will be further developed for release through continued collaboration with staff members. The content of this e-learning module will be supported by empirically validated research on sexuality after TBI (Deschênes et al., 2019; Downing et al., 2018; Fraser et al., 2020; Fraser et al., 2024; Hwang et al., 2021; Hwang et al., 2024; Patsakos et al., 2024). All clinical staff members of the rehabilitation unit, new and existing, will be required to undergo this mandatory e-learning module.

To monitor adherence to the intervention, the Epworth e-learning team will keep track of completion status amongst employed staff members through website analytics.

Intervention code [1] 330608 0
Rehabilitation
Comparator / control treatment
For the primary aim of the study, clinician participants serve as their own controls through comparison of change through three timepoints; a pre-module baseline timepoint, post-module completion timepoint, and follow-up at approximately 3 months after.

For the secondary aims of the study, a pre-module implementation patient group will serve as historical control for a post-module implementation patient group. All patient participants will be contacted for recruitment at least a month after discharging from the rehabilitation unit. Pre-implementation patients would be discharged up to approximately a year prior to the launch of the e-module and post-implementation patients would be discharged up to a year after the launch.
Control group
Active

Outcomes
Primary outcome [1] 340831 0
Clinician attitudes and beliefs
Timepoint [1] 340831 0
(1) pre-module baseline, (2) immediately after completing module, (3) approximately 3 months following completion of module
Primary outcome [2] 340832 0
Penetration: Ratio of number of patients with whom sexuality was addressed with divided by the number of eligible or potential participants.
Timepoint [2] 340832 0
Pre-module implementation patient participant data compared against post-implementation patient participant data. Participants will be assessed at least one month after discharge from unit.
Secondary outcome [1] 445194 0
Fidelity implementation outcome
Timepoint [1] 445194 0
(1) pre-module baseline, (2) immediately after completing module, (3) approximately 3 months following completion of module
Secondary outcome [2] 445202 0
Patient sexuality outcome
Timepoint [2] 445202 0
Pre-module implementation patient participant data compared against post-implementation patient participant data. Participants will be assessed at least one month after discharge from unit.
Secondary outcome [3] 445203 0
Patient ratings of experiences of sexuality support received
Timepoint [3] 445203 0
Pre-module implementation patient participant data compared against post-implementation patient participant data. Participants will be assessed at least one month after discharge from unit.
Secondary outcome [4] 445625 0
Clinician ratings of acceptability of e-learning module
Timepoint [4] 445625 0
Immediately after completing module
Secondary outcome [5] 446026 0
Clinician ratings of usability of e-learning module
Timepoint [5] 446026 0
Immediately after completion of module
Secondary outcome [6] 446027 0
Patient ratings of satisfaction with sexuality support received
Timepoint [6] 446027 0
Pre-module implementation patient participant data compared against post-implementation patient participant data. Participants will be assessed at least one month after discharge from unit.

Eligibility
Key inclusion criteria
For clinician participants:
- Clinicians working at the Epworth ABI rehabilitation unit with patients

For patient participants:
- community dwelling individuals with traumatic brain injury aged 18 and above.
- Adequate English and cognitive skills to complete questionnaires independently
- sustained complicated mild to very severe TBI
- greater than one month post discharge from the Epworth ABI rehabilitation inpatient unit
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Inadequate cognitive capacity to provide informed consent

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Pre-post design.
Repeated measure design for clinician participants.
Historical control design for patient participants.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2025
Actual
Date of last participant enrolment
Anticipated
26/02/2026
Actual
Date of last data collection
Anticipated
27/05/2026
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27660 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 43834 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 318535 0
Government body
Name [1] 318535 0
National Health and Medical Research Council
Country [1] 318535 0
Australia
Funding source category [2] 318537 0
Charities/Societies/Foundations
Name [2] 318537 0
Epworth Medical Foundation
Country [2] 318537 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320931 0
None
Name [1] 320931 0
Address [1] 320931 0
Country [1] 320931 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317138 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 317138 0
Ethics committee country [1] 317138 0
Australia
Date submitted for ethics approval [1] 317138 0
08/10/2021
Approval date [1] 317138 0
20/06/2022
Ethics approval number [1] 317138 0
80518

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

Contacts
Principal investigator
Name 140126 0
Prof Jennie Ponsford
Address 140126 0
Monash Epworth Rehabilitation Research Centre, Ground Floor 185-187 Hoddle Street, RICHMOND VIC 3121
Country 140126 0
Australia
Phone 140126 0
+61 03 9426 8925
Fax 140126 0
Email 140126 0
[email protected]
Contact person for public queries
Name 140127 0
Prof Jennie Ponsford
Address 140127 0
Monash Epworth Rehabilitation Research Centre, Ground Floor 185-187 Hoddle Street, RICHMOND VIC 3121
Country 140127 0
Australia
Phone 140127 0
+61 03 9426 8925
Fax 140127 0
Email 140127 0
[email protected]
Contact person for scientific queries
Name 140128 0
Dr Jill Hwang
Address 140128 0
Monash Epworth Rehabilitation Research Centre, Ground Floor 185-187 Hoddle Street, RICHMOND VIC 3121
Country 140128 0
Australia
Phone 140128 0
+61 416821050
Fax 140128 0
Email 140128 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.