Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000004460
Ethics application status
Approved
Date submitted
4/11/2024
Date registered
7/01/2025
Date last updated
7/01/2025
Date data sharing statement initially provided
7/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The ENhAnCe trial: Evaluating Neuropsychological Assessment to enhance Clinical outcomes for people with brain conditions
Scientific title
The ENhAnCe trial: Evaluating Neuropsychological Assessment to enhance Clinical outcomes for people with brain conditions
Secondary ID [1] 312774 0
None
Universal Trial Number (UTN)
Trial acronym
ENhAnCe trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurodegenerative disorder 334825 0
Psychiatric disorder 334826 0
Acquired brain injury 335983 0
Mild cognitive impairment 335986 0
Condition category
Condition code
Neurological 331384 331384 0 0
Epilepsy
Mental Health 331382 331382 0 0
Depression
Neurological 331379 331379 0 0
Neurodegenerative diseases
Injuries and Accidents 331812 331812 0 0
Other injuries and accidents
Neurological 331380 331380 0 0
Other neurological disorders
Mental Health 331383 331383 0 0
Other mental health disorders
Mental Health 331381 331381 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Condition: Neuropsychological evaluation
This will involve an individualised comprehensive neuropsychological assessment and invitation to a feedback session, to which family members/support persons may also be invited. The assessments and feedback sessions will be conducted by registered clinical neuropsychologists/clinical neuropsychology registrars employed at the clinical site and provisional psychologists under supervision by registered clinical neuropsychologists.
The neuropsychological assessments will be conducted using a flexible evaluation approach, which involves adjustment of the neuropsychology test battery on the basis of suspected cognitive impairments, differential diagnoses, and the specific referral question. Where clinically indicated all major cognitive domains will be assessed as well as measures of performance validity. Major cognitive domains include attention, memory, language, visuospatial abilities and executive function.
Because this is an intervention that follows a flexible evaluation approach, the length of the neuropsychological assessment can vary from a minimum 90 minutes to a maximum of five hours. Feedback sessions typically last between 30 to 90 minutes. Typically a feedback session would include explanation of the participant's cognitive strengths and weaknesses, formulation of the underlying causes for any cognitive difficulties identified, and strategies and recommendations for how to manage those difficulties. A more detailed account of the typical content in neuropsychological feedback sessions can be found in Longley et al. (2023) and the Psychology Competency Assessment Tool - Feedback checklist (PsyCET-F; Wong et al., 2023), the latter of which will be utilised in this trial to assess intervention fidelity.
To establish adherence to the neuropsychological assessment intervention condition, this will be achieved by attendance at the neuropsychological appointment. The clinician will have needed to complete the Clinician PrONTo outcome measure, which will confirm that this has occurred. Adherence to the brief cognitive screen intervention condition will be established by attendance at the brief cognitive screen (MoCA) appointment and the generation of a score that is sent back to the referrer. Thus, adherence to the intervention will be assessed by attendance at these appointments plus the clinician's ratings on the PsyCET-F for a random subset of participants to ensure competency of delivered feedback.
Family members/support persons are not typically present for the full neuropsychological assessment, nor the brief cognitive screen, however they will be invited to attend the feedback session with the participant's consent.

References:
Longley, W. A., Tate, R. L., & Brown, R. F. (2023). The psychological benefits of neuropsychological assessment feedback as a psycho-educational therapeutic intervention: A randomized-controlled trial with cross-over in multiple sclerosis. Neuropsychological Rehabilitation, 33(5), 764-793.
Wong, D., Pinto, R., Price, S., Watson, L., & McKay, A. (2023). What does competently delivered neuropsychological assessment feedback look like? Development and validation of a competency evaluation tool. The Clinical Neuropsychologist, 38(1), 116-134.
Intervention code [1] 329303 0
Treatment: Other
Comparator / control treatment
Active Control: Brief cognitive screen
The Montreal Cognitive Assessment (MoCA) is a single-paged test that can be administered in ten minutes and is scored out of 30 points. Cognitive impairment is indicated by a performance that is below the cut-off score of 26, with one-point added to the participant’s score if they have less than 12 years education. No feedback on the results of the MoCA will be provided to the participant/support person. The numerical results of the MoCA will be emailed to the referrer with a brief generic text interpretation of the score.
The brief cognitive screening condition will take the format of an active control, whereby participants allocated to the brief cognitive screening condition will still receive a neuropsychological assessment as part of their standard clinical care after the active phase of the trial. The timeline of the RCT protocol has thus been designed with consideration of the expected waitlist duration at the clinical site, to ensure that participants complete all aspects of the trial prior to reaching the top of the waitlist for neuropsychological assessment (i.e., not hindering their clinical care).
Control group
Active

Outcomes
Primary outcome [1] 340083 0
Change in the participant/support person’s understanding of how to manage/cope with cognitive symptoms
Timepoint [1] 340083 0
Baseline, two-weeks post intervention, and six-week follow-up.
Primary outcome [2] 339736 0
Change in the participant/support person’s understanding of the participant’s difficulties.
Timepoint [2] 339736 0
Baseline, two-weeks post intervention, and six-week follow-up.
Secondary outcome [1] 441034 0
Carer burden
Timepoint [1] 441034 0
Baseline, two-weeks post intervention, and six-week follow-up.
Secondary outcome [2] 441032 0
Self-efficacy
Timepoint [2] 441032 0
Baseline, two-weeks post intervention, and six-week follow-up.
Secondary outcome [3] 441031 0
Depression symptomatology
Timepoint [3] 441031 0
Baseline, two-weeks post intervention, and six-week follow-up.
Secondary outcome [4] 441035 0
Referrer satisfaction
Timepoint [4] 441035 0
End of the trial period (i.e., six-week follow-up)
Secondary outcome [5] 441030 0
Acceptability rating
Timepoint [5] 441030 0
End of the trial period (i.e., six-week follow-up)
Secondary outcome [6] 441033 0
Health-related quality of life
Timepoint [6] 441033 0
Baseline, two-weeks post intervention, and six-week follow-up.
Secondary outcome [7] 442589 0
Anxiety symptomatology
Timepoint [7] 442589 0
Baseline, two-weeks post intervention, and six-week follow-up.
Secondary outcome [8] 442590 0
Stress symptomatology
Timepoint [8] 442590 0
Baseline, two-weeks post intervention, and six-week follow-up.

Eligibility
Key inclusion criteria
Inclusion criteria will be that participants;
i) have been referred to the clinical site for a neuropsychological assessment to assist clinical management or diagnostic clarification,
ii) are able to provide informed consent to participate in research, and
iii) are able to complete the baseline and outcome measures.

One support person of each participant will also be invited to participate if they are willing and available. Inclusion criteria for the support person will be that they:
i) have known the participant for a minimum of 12 months (e.g., family member or paid carer),
ii) are able to provide informed consent to participate in the study,
iii) are aged 18 years or older, and
iv) able to complete the informant baseline and outcome assessment measures administered in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include participants:
i) who do not meet the referral criteria for the Adult General Diagnostic program at the clinical site.
ii) who have been referred for a decision-making capacity assessment,
iii) who have been referred for a joint neuropsychological assessment and speech pathology assessment,
iv) who are unable to provide informed consent for themselves,
v) who require an urgent neuropsychological assessment (e.g., for discharge from an acute setting),
vi) who have severe communication difficulties (e.g., secondary to aphasia) or are not fluent in English, impacting their ability to complete the outcome measures in English,
vii) with acute risk of harm to self and/or others, and
viii) participants who have previously had a neuropsychological assessment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation sequence will be concealed, whereby the allocation schedule will be generated and retained by an off-site independent researcher and kept hidden from all members of the research team. Each allocation will then be sealed in a consecutively numbered opaque envelope by the independent researcher and the set of envelopes will be given to the enrolling investigator. When the enrolling investigator seeks to enrol and randomise a new participant, the participant’s name will be written on the front of the next available envelope prior to opening the sealed envelope and retrieving the allocation from inside. The enrolling investigator will thus not be aware of the full sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following enrolment and informed consent, individual randomisation to intervention condition will be completed using an online random sequence generator (randomizer.org). Randomisation will be stratified by suspected/established diagnostic group (i.e., neurodegenerative, acquired brain injury, general medicine, and psychiatric ) to ensure diagnostic category is balanced across intervention conditions. Group allocation will be via a covariate-adaptive randomisation to optimise the balance among groups with respect to diagnostic category (suspected or established), following the biased coin randomisation process.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A sample size of 100 participants (50 in each condition) accords with recommended sample sizes for pilot studies (Eldridge et al., 2016; Sim & Lewis, 2012) and will allow us to robustly estimate the expected effect size parameters for a larger definitive trial.
Pairwise comparisons and linear mixed models will be used to investigate between-group differences at each time point in clinical outcomes. Group allocation will be via a covariate-adaptive randomisation to optimise the balance among groups with respect to diagnostic category (suspected or established), following the biased coin randomisation process. In line with this randomisation method, diagnostic category will be included in the analysis as covariates. Confidence intervals will be reported and the effect size of each intervention condition, defined as the magnitude of change from T1-T3, will be estimated with Cohen’s d based on output from regression models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317707 0
Charities/Societies/Foundations
Name [1] 317707 0
Forrest Research Foundation PhD Scholarship
Country [1] 317707 0
Australia
Funding source category [2] 317708 0
Government body
Name [2] 317708 0
Insurance Commission of Western Australia Neurotrauma Research Program
Country [2] 317708 0
Australia
Funding source category [3] 317207 0
University
Name [3] 317207 0
Australian Government Research Training Program (RTP) Scholarship
Country [3] 317207 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 320028 0
None
Name [1] 320028 0
Address [1] 320028 0
Country [1] 320028 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316402 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 316402 0
Ethics committee country [1] 316402 0
Australia
Date submitted for ethics approval [1] 316402 0
29/05/2024
Approval date [1] 316402 0
01/07/2024
Ethics approval number [1] 316402 0
Ethics committee name [2] 315944 0
North Metropolitan Area Mental Health Services Human Research Ethics Committee
Ethics committee address [2] 315944 0
Ethics committee country [2] 315944 0
Australia
Date submitted for ethics approval [2] 315944 0
28/01/2024
Approval date [2] 315944 0
16/05/2024
Ethics approval number [2] 315944 0

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

Contacts
Principal investigator
Name 136302 0
Miss Nicole Feast
Address 136302 0
School of Psychological Science, The University of Western Australia, 35 Stirling Highway, Crawley WA 6009
Country 136302 0
Australia
Phone 136302 0
+61 8 6488 1415
Fax 136302 0
Email 136302 0
[email protected]
Contact person for public queries
Name 136303 0
Nicole Feast
Address 136303 0
School of Psychological Science, The University of Western Australia, 35 Stirling Highway, Crawley WA 6009
Country 136303 0
Australia
Phone 136303 0
+61 8 6488 1415
Fax 136303 0
Email 136303 0
[email protected]
Contact person for scientific queries
Name 136304 0
Nicole Feast
Address 136304 0
School of Psychological Science, The University of Western Australia, 35 Stirling Highway, Crawley WA 6009
Country 136304 0
Australia
Phone 136304 0
+61 8 6488 1415
Fax 136304 0
Email 136304 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.