Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000587404
Ethics application status
Approved
Date submitted
9/05/2025
Date registered
5/06/2025
Date last updated
5/06/2025
Date data sharing statement initially provided
5/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a ‘culturally tailored iSupport model’ for carers of people with dementia
Scientific title
Impact of a ‘culturally tailored iSupport model’ on quality of life for carers of people with dementia
Secondary ID [1] 314279 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carer distress 337219 0
General well-being 337216 0
Dementia-related symptoms and behaviours 337218 0
Condition category
Condition code
Mental Health 334053 334053 0 0
Other mental health disorders
Neurological 333626 333626 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention titled 'culturally tailored iSupport model' is designed for carers of people with dementia from culturally and linguistically diverse (CALD) backgrounds. The intervention will be compared to a usual care group.
The core components of the 'culturally tailored iSupport model' interventaion are:

1) Facilitator-enabled access to and utilisation of care services: In each study site, CALD carers will be assigned to a facilitator matched for culture and language. They will be encouraged to request individualised support from the facilitator during transition between care types and settings of the people living with dementia (PLWD), at a time of change for PLWD and gain advice to access relevant multidisciplinary care services for timely treatment and care. The facilitator will follow the carers until their preferences needs for support have been met, as:
• Individualising support for CALD carers: Guide carers in accessing multidisciplinary services for PLWD on a timely manner; support carers during transitions in care type and setting; assist during times of change or escalating needs in PLWD; facilitate access to culturally appropriate care services to address high dependency, chronic illness, and behavioural challenges—helping prevent crises and hospitalisations; introduce carers to dementia care resources, including iSupport content; build carers’ skills in coping, self-care, problem-solving, and assertiveness through iSupport manual contents; act as cultural brokers to enhance culturally responsive services.
• Interacting with CALD Carers: matched by culture and language to build rapport and trust; serve as a consistent point of contact for service navigation; carers initiate contact for one-on-one support based on their needs; duration and frequency of support are flexible and needs-based (run monthly carer support group sessions); offer individual follow-up opportunities, especially for feedback; use phone, WhatsApp or WeChat platform for online interaction or face-to-face interaction; engagement sessions typically last 45–60 mins depending on type and follow-up sessions last 5-10 minutes.
• Supporting carers: Provide practical advice on service access and utilisation; continuously follow up until carers' needs are addressed; use structured tools (e.g., carer risk assessment and coaching tools, videos) to identify and respond to needs; gather carer feedback into organisational improvements. Engagement sessions typically last 45–60 mins depending on type and follow-up sessions last 5-10 minutes.
• Strategies for monitoring the adherence to the interventions: Facilitators will maintain monthly portfolios which will be reviewed by site leaders. Carers will provide feedback on the intervention they received via a satisfaction survey quarterly and interviews and focus groups at 6 months and 12 months post-baseline.

2. Care support group:
In each study site, facilitators will assign carers into support groups of 5-10 carers, matched by cultural and linguistic background. Carers are expected to participate in these monthly meetings for the 12-month duration of the intervention. Each meeting is planned to last between 45 and 60 minutes. Meetings will involve facilitator-led discussions and group sharing, focusing on a standard meeting agenda that includes facilitating positive thoughts of care, managing disease progression and changes, coaching carers in self-care, and caring for their relatives with dementia, allowing carers to share experiences and support each other. Meetings will be recorded for carers in the same group to access. Participant attendance and activities in the support groups will be tracked through the facilitators' monthly portfolios, which will be reviewed and audit, serving as a method to monitor the adherence to the intervention. Facilitators, who share the participants' culture and language, will actively encourage ongoing communication and connection among peers in the group, such as through talking or text messages, to strengthen social support. The text massages will be downloaded as part of research data for analysis by the research team.

3. Psychoeducation: Facilitators will engage CALD carers with the iSupport program in their preferred language and preferred formats (i.e., web-based iSupport, iSupport handbook or iSupport videos). The iSupport program is a psychoeducation program developed and endorsed by the World Health Organization (WHO), designed to enable carers to develop capabilities to manage dementia while reducing their psychological stress. The Australian iSupport program comprises six modules with 29 units, covering areas such as introduction to dementia, being a carer, caring for oneself, providing everyday care, a person-centred approach to changes in behaviour, and engagement in consumer directed care. The program also addresses dementia care from the early stage to the end of life. Carers will be encouraged to complete at least 20 out of 29 relevant learning units. The expected time spent on learning from the iSupport program is around 20 minutes per week. Participants will have access to the iSupport program as part of the 12-month intervention period. Carers will receive a certificate for each unit they complete, which serves as a motivational strategy. Strategies used to assess or monitor adherence include facilitators’ engagement with carers in learning needs assessment to identify relevant units; documenting their activities and outcomes in a structured 'Facilitator's Portfolio'. These portfolios will be reviewed by site leaders and the project team monthly as part of project audit activities.

4. Feedback on services: The facilitators will encourage carers to provide feedback on care services, specifically via monthly carer support group meetings or individual meetings with the facilitators. This feedback will be discussed in their organisation’s quality improvement meetings, and facilitators will act as cultural brokers to assist their organisation to improve culturally tailored care services for PLWD and their carers. The facilitators will also report the organisation’s actions and quality improvement outcomes back to carers in the intervention group.
Intervention code [1] 330890 0
Treatment: Other
Comparator / control treatment
As part of the usual care group, CALD carers will be directed to Dementia Australia and/or the iSupport program website for accessing dementia care resources, including iSupport in their preferred language, by a researcher.
Control group
Active

Outcomes
Primary outcome [1] 341203 0
Carers' quality of life using 12-Item Short-Form Health Survey (SF-12).
Timepoint [1] 341203 0
The questionnaire will be completed at baseline, 6 months and 12 months post-initiation of the intervention. The primary timepoint is 6 months post-initiation of the intervention.
Primary outcome [2] 341204 0
Care recipients’ Quality of Life in Alzheimer’s Disease (QOL-AD)-Proxy
Timepoint [2] 341204 0
The questionnaire will be completed at baseline, 6 months and 12 months post-initiation of the intervention. The primary timepoint is 6 months post-initiation of the intervention.
Secondary outcome [1] 446764 0
Caregiving Self-Efficacy Scale
Timepoint [1] 446764 0
The questionnaire will be completed at baseline, 6 months and 12 months post-initiation of the intervention.
Secondary outcome [2] 447353 0
Carer recipients; Combined measure of health and social care visits (excluding MBS-covered services), collected using the ‘Resource Utilisation in Dementia’ questionnaire.
Timepoint [2] 447353 0
The questionnaire will be completed at baseline, 6 months and 12 months post-initiation of the intervention.
Secondary outcome [3] 446767 0
Care recipients' Quality of Care Experience (QCE) Measure.
Timepoint [3] 446767 0
The questionnaire will be completed at baseline, 6 months and 12 months post-initiation of the intervention.
Secondary outcome [4] 446905 0
Carer recipients: Combined measure of hospital admissions, emergency department presentations, and use of permanent residential aged care.
Timepoint [4] 446905 0
The questionnaire will be completed at baseline, 6 months and 12 months post-initiation of the intervention.
Secondary outcome [5] 447354 0
Carers: Carers in the intervention group will be encouraged to provide feedback on the care services received by their care recipients.
Timepoint [5] 447354 0
The feedback will be collected through focus group discussions or interviews at 6 months and 12 months post-intervention.
Secondary outcome [6] 447359 0
Facilitator experiences: Composite measure of facilitators’ perspectives on implementing and monitoring the model, including outcome evaluation, self-assessment, and observations on organisational knowledge and environmental adjustments during the implementation phase.
Timepoint [6] 447359 0
Monthly for 12 months during the trial
Secondary outcome [7] 446765 0
Carers' Quality of Social Support Scale
Timepoint [7] 446765 0
The questionnaire will be completed at baseline, 6 months and 12 months post-initiation of the intervention.
Secondary outcome [8] 446766 0
The Revised Memory and Behaviour Problem Checklist
Timepoint [8] 446766 0
The questionnaire will be completed at baseline, 6 months and 12 months post-initiation of the intervention.

Eligibility
Key inclusion criteria
1) Carers speak one of these languages at home: Italian, Greek, Mandarin, Cantonese, Vietnamese, Bahasa or Spanish;
2) Carers are aged 18 years or over;
3) Carers provide care for older people (aged greater than or equal to 65) living with dementia from a culturally and linguistically diverse background at least twice a week. If the care recipients have not been formally diagnosed with dementia but meet the score 10 to 22 using the Rowland Universal Dementia Assessment Scale (RUDAS) or a score between 10 and 24 using the Mini Mental State Examination (MMSE).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Carers will be excluded if they (1) have health conditions that may significantly impact their ability to participate in the study; (2) involve in other studies, and (3) cannot read English without additional assistance.

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)
Allocation concealment is ensured by:
1. Participants will be assigned a code by a research assistant
2. The biostatistician who has no contact with participants will randomly assign the code into groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After baseline data collection, carers will be randomly assigned to receive either the 'Tailored Culturally iSupport model' or the usual care. To ensure the two groups are of equivalent size and conditions, a block randomisation will be used to allocate carers to one of the two treatment groups for each recruitment site. Stratification will also be used in the block
randomisation to ensure equivalent distribution of language groups, spouse carers versus nonspouse carers and care recipients with a similar stage of dementia in each treatment group. The randomisation will be performed by a statistician who is blinded to participants and will not be involved in data analysis.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A statistician, who will be blinded to group assignments, will undertake data analysis. Data will be analysed on an intention-to-treat basis based on group assignments. A multivariate mixed effect linear regression model will be applied to fit linear mixed models to examine the primary and secondary outcomes between groups. As the outcome occurs for each individual with repeated time points, the mixed effect models will capture both fixed effects and random effects within the hierarchical structure of the data. The fixed effects, including group effect, time effect and group x time interaction, will be analogous to the regression coefficients. The random effects represent the estimated variability in the intercept to account for repeated measurements. The model will be adjusted by the baseline measure of outcome variable. The maximum likelihood estimate procedure will be used to compare significant differences in primary and secondary outcomes over time and between groups. Univariate models will be first used, then multivariate modelling will be undertaken by adding variables considered clinically important or statistically significant from the univariate model to adjust for confounding effects between variables. A series of models will be undertaken by adding and subtracting variables, with changes in model fit assessed by log likelihood to choose the final multivariate model. The two-sided test will be performed for all analyses and the level of significance will be set at p <0.05. All analyses will be performed using Stata software version 16.1. and R version 4.2.2.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2026
Actual
Date of last data collection
Anticipated
31/08/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 318797 0
Government body
Name [1] 318797 0
National Health and Medical Research Council: 2022 TCR Cultural Ethnic and Linguistic Diversity in Dementia Research
Country [1] 318797 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 321311 0
Other
Name [1] 321311 0
Bolton Clarke
Address [1] 321311 0
Country [1] 321311 0
Australia
Secondary sponsor category [2] 321310 0
University
Name [2] 321310 0
Western Sydney University
Address [2] 321310 0
Country [2] 321310 0
Australia
Other collaborator category [1] 283495 0
Other
Name [1] 283495 0
Pronia, Victoria
Address [1] 283495 0
Country [1] 283495 0
Australia
Other collaborator category [2] 283496 0
Other
Name [2] 283496 0
Multicultural Aged Care, SA
Address [2] 283496 0
Country [2] 283496 0
Australia
Other collaborator category [3] 283492 0
Charities/Societies/Foundations
Name [3] 283492 0
Chinese Australian Services Society (CASS)
Address [3] 283492 0
Country [3] 283492 0
Australia
Other collaborator category [4] 283497 0
Other
Name [4] 283497 0
Murray Mallee Aged Care Group, SA
Address [4] 283497 0
Country [4] 283497 0
Australia
Other collaborator category [5] 283493 0
Charities/Societies/Foundations
Name [5] 283493 0
Australian Nursing Home Foundation (ANHF)
Address [5] 283493 0
Country [5] 283493 0
Australia
Other collaborator category [6] 283494 0
Charities/Societies/Foundations
Name [6] 283494 0
United - Spanish Latin American Welfare Centre Inc
Address [6] 283494 0
Country [6] 283494 0
Australia
Other collaborator category [7] 283498 0
Other
Name [7] 283498 0
Community Services and Access, SA
Address [7] 283498 0
Country [7] 283498 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317405 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 317405 0
Ethics committee country [1] 317405 0
Australia
Date submitted for ethics approval [1] 317405 0
24/03/2025
Approval date [1] 317405 0
23/04/2025
Ethics approval number [1] 317405 0
HEG8271

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

Contacts
Principal investigator
Name 140958 0
Prof Lily Xiao
Address 140958 0
College of Nursing and Health Sciences Flinders University Sturt Road, Bedford Park 5042 GPO Box 2100 Adelaide SA
Country 140958 0
Australia
Phone 140958 0
+61 8 82013149
Fax 140958 0
Email 140958 0
[email protected]
Contact person for public queries
Name 140959 0
Lily Xiao
Address 140959 0
College of Nursing and Health Sciences Flinders University Sturt Road, Bedford Park 5042 GPO Box 2100 Adelaide SA
Country 140959 0
Australia
Phone 140959 0
+61 8 82013149
Fax 140959 0
Email 140959 0
[email protected]
Contact person for scientific queries
Name 140960 0
Lily Xiao
Address 140960 0
College of Nursing and Health Sciences Flinders University Sturt Road, Bedford Park 5042 GPO Box 2100 Adelaide SA
Country 140960 0
Australia
Phone 140960 0
+61 8 82013149
Fax 140960 0
Email 140960 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Please contact the principal investigator in this project. The contact details for the principal investigator is listed in the following:
Professor Lily Xiao
Email: [email protected]


Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Letter.pdf


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.