Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001281886
Ethics application status
Approved
Date submitted
19/05/2021
Date registered
23/09/2021
Date last updated
25/04/2024
Date data sharing statement initially provided
23/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of dementia training on interpreters' communication during cognitive assessments
Scientific title
The impact of dementia training on interpreters' quality of communication during interpreter-mediated cognitive assessments: The MINDSET study
Secondary ID [1] 304090 0
NHMRC Application ID: APP2005759
Universal Trial Number (UTN)
Trial acronym
MINDSET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 321758 0
Condition category
Condition code
Neurological 319500 319500 0 0
Dementias
Public Health 319501 319501 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Language interpreters will be given access to an online training program on language interpreting for people living with dementia.
The program will be accessed by participants entering a username and password on our (NARI) website.
The training will be self paced and will take approximately 3-4 hours in total.
The interpreters will have a window of 3 months within which they must complete the training.

Prior to the trial, the training modules will be produced through a co-design process involving clinicians, interpreters, people with dementia and family carers.

The training will include modules covering:
- Dementia awareness
- Dementia-related phraseology and terminology
- Cognitive assessment instruments
- Interpreting practice for cognitive assessments
- Professional ethics
Intervention code [1] 320423 0
Behaviour
Comparator / control treatment
The control group will be language interpreters who do not undertake the training program during the trial. They will be given access to the training after they have completed their final assessment of the trial, i.e. 6 months after the baseline assessment.
Control group
Active

Outcomes
Primary outcome [1] 327364 0
Quality of interpreted communication measured via a battery composite z score evaluating five interpreting domains (phraseology, terminology, ethics, contextual knowledge, cross-cultural communication).

Assessment will comprise of a video-simulation of an interpreted consultation and a questionnaire.

The following instruments compose the z score:
a) NAATI certified interpreter test assessment rubric - phraseology, terminology (Video-simulation)
b) the Dementia-Knowledge Assessment Scale - contextual knowledge (Questionnaire)
c) a bespoke questionnaire covering ethical practices, and cross cultural communication - ethics, cross-cultural communication (Questionnaire)
Timepoint [1] 327364 0
Baseline, 3 months (primary timepoint), and 6 months after intervention commencement.
Secondary outcome [1] 401248 0
nil
Timepoint [1] 401248 0
nil

Eligibility
Key inclusion criteria
Interpreters NAATI credentialed as either a recognised, provisionally certified, or professionally certified interpreter.
Practising for 6+ months
Have an internet connection
Interpret for Greek, Italian, Mandarin, Cantonese, Vietnamese, or Arabic languages.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Involved in the development/pilot testing of training materials.

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)
Baseline outcome scores will be concealed from the statistician completing randomized allocation of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic randomization using minimization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
It is not possible to conceal allocation from study participants either undertaking training during the trial period or being assigned to a wait list. Hence, this will be a single-blinded trial, where allocation is concealed from outcome assessors.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 120 (60 test and 60 control) participants (interpreters) is sufficient to detect with 80% power and alpha of 0.05, a difference in control and test group means of 1.3 with standard deviation of 2.5. The calculations are the customary ones based on normal distributions. To evaluate our primary outcome we will use mixed effects generalised linear regression.
We will aim to recruit 150 participants overall (75 test and 75 control) to account for potential drop-out.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2022
Actual
27/06/2022
Date of last participant enrolment
Anticipated
30/11/2022
Actual
2/04/2023
Date of last data collection
Anticipated
31/10/2023
Actual
14/11/2023
Sample size
Target
150
Accrual to date
Final
167
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308474 0
Government body
Name [1] 308474 0
National Health and Medical Research Council
Country [1] 308474 0
Australia
Funding source category [2] 308476 0
Other Collaborative groups
Name [2] 308476 0
National Accreditation Authority for Translators and Interpreters Ltd
Country [2] 308476 0
Australia
Funding source category [3] 308477 0
Commercial sector/Industry
Name [3] 308477 0
All Graduates Interpreting and Translation Services
Country [3] 308477 0
Australia
Funding source category [4] 308478 0
Other Collaborative groups
Name [4] 308478 0
Australian Institute of Interpreters and Translators (AUSIT)
Country [4] 308478 0
Australia
Funding source category [5] 308626 0
Government body
Name [5] 308626 0
The Translating and Interpreting Service (TIS National)
Country [5] 308626 0
Australia
Funding source category [6] 308627 0
Charities/Societies/Foundations
Name [6] 308627 0
Dementia Australia
Country [6] 308627 0
Australia
Funding source category [7] 308628 0
Charities/Societies/Foundations
Name [7] 308628 0
Migrant and Refugee Health Partnership
Country [7] 308628 0
Australia
Funding source category [8] 308629 0
Government body
Name [8] 308629 0
Healthcare Interpreter Service (NSW)
Country [8] 308629 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Ageing Research Institute Ltd.
Address
PO Box 2127, Royal Melbourne Hospital VIC 3050
Country
Australia
Secondary sponsor category [1] 309497 0
None
Name [1] 309497 0
Address [1] 309497 0
Country [1] 309497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308430 0
Curtin University HREC
Ethics committee address [1] 308430 0
Ethics committee country [1] 308430 0
Australia
Date submitted for ethics approval [1] 308430 0
14/05/2021
Approval date [1] 308430 0
13/08/2021
Ethics approval number [1] 308430 0
HRE2021-0477
Ethics committee name [2] 311519 0
University of Western Australia
Ethics committee address [2] 311519 0
Ethics committee country [2] 311519 0
Australia
Date submitted for ethics approval [2] 311519 0
10/08/2022
Approval date [2] 311519 0
24/08/2022
Ethics approval number [2] 311519 0
2022/ET000576

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

Contacts
Principal investigator
Name 110682 0
Prof Bianca Brijnath
Address 110682 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital VIC 3050
Country 110682 0
Australia
Phone 110682 0
+613 8387 2294
Fax 110682 0
Email 110682 0
[email protected]
Contact person for public queries
Name 110683 0
Simona Markusevska
Address 110683 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital VIC 3050
Country 110683 0
Australia
Phone 110683 0
+613 8387 2567
Fax 110683 0
Email 110683 0
[email protected]
Contact person for scientific queries
Name 110684 0
Bianca Brijnath
Address 110684 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital VIC 3050
Country 110684 0
Australia
Phone 110684 0
+613 8387 2294
Fax 110684 0
Email 110684 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11533Study protocolBrijnath, B., LoGiudice, D., Gonzalez Garcia, E. Low, L-F., Woodward Kron, R., Hlavac, J., Enticott, J., Antoniades, J., Gilbert, A., Lin, X., White, J., Hwang, K. (2021) Protocol: Improving interpreting for dementia assessments: The MINDSET Study. Parkville, Australia: National Ageing Research Institute.  [email protected]
11705Informed consent formBrijnath, B., LoGiudice, D., Gonzalez Garcia, E. Low, L-F., Woodward Kron, R., Hlavac, J., Enticott, J., Antoniades, J., Gilbert, A., Lin, X., White, J., Hwang, K. (2021) MINDSET Participant Information and Consent Form. Parkville, Australia: National Ageing Research Institute.  [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.