Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001380583
Ethics application status
Approved
Date submitted
31/10/2024
Date registered
21/11/2024
Date last updated
21/11/2024
Date data sharing statement initially provided
21/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
MINDCARE: Co-producing a dementia risk reduction program for Culturally & Linguistically Diverse (CALD) communities to improve health self-efficacy
Scientific title
MINDCARE: Co-producing a dementia risk reduction program for Culturally & Linguistically Diverse (CALD) communities to improve health self-efficacy
Secondary ID [1] 311179 0
MRFF2023269
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 332357 0
Condition category
Condition code
Public Health 329065 329065 0 0
Health promotion/education
Neurological 332245 332245 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Approximately 96 to 120 adults aged 40 and over from Arabic-, Vietnamese-, Greek-, and Hindi-speaking communities in Australia will participate in a dementia prevention intervention through an educational program, the “MindCare program”, delivered by community peer educators at the sites of five partner organisations. The program is designed to improve self-efficacy, health literacy, and knowledge of dementia risk reduction among community members from culturally and linguistically diverse (CALD) backgrounds. It has been specifically tailored for Australians from Arabic-, Vietnamese-, Greek-, and Hindi-speaking groups.
The MindCare program was developed through a comprehensive co-design process involving members of the target communities, clinicians, and service providers. The co-production process occurred in three following stages:
The first stage included six co-production workshops conducted in English to develop a multicultural base program. Each workshop lasted approximately two hours and involved 8-12 participants, including consumers and service providers from the Arabic-, Vietnamese-, Greek-, and Hindi-speaking communities. Participants reviewed dementia risk reduction materials and provided feedback on the content, format, and cultural relevance, which was integrated iteratively.
The second stage consisted of seven cultural adaptation workshops and five individual sessions, where bilingual research assistants facilitated sessions in the respective languages to tailor the program for each community. Each group session lasted approximately two hours and included 2-10 participants who refined the materials based on cultural and linguistic needs.
Following cultural adaptation workshops, the program was circulated to all participants for memberchecking and feedback. Further to this the MindCare program is currently undergoing user testing with up to 15 participants from Hindi, Vietnamese, Arabic and Greek speaking backgrounds as well as sessions in English, User testing sessions (2-3 hours) assess usability, cultural relevance, and engagement to ensure the program is culturally and linguistically appropriate and ready for the trial.

The intervention using the MindCare program, as finalised after the above testing with community members, is a 3-hour workshop delivered in person in community settings by bilingual peer educators who are bilingual members of the CALD communities and engaged by the project's partner organisations (Ethnic Communities’ Council of Victoria
Multicultural Aged Care, South Western Sydney Local Health District, SydWest Multicultural Services, Umbrella Multicultural Community Care). The workshops provide a brief introduction to dementia, but the main focus is to educate participants about the modifiable lifestyle risk factors that can reduce the risk of developing dementia, and that people can potentially address through simple everyday actions (e.g. getting a hearing check, or making sure to get your cholesterol checked at the GP from time to time).
The program includes components to encourage engagement such as discussions, culturally relevant examples, in-language multimedia materials (such as the short films and animations developed by the MovingPictures research team, available at https://www.movingpictures.org.au/), and goal-setting activities where participants set personal health goals related to dementia risk reduction.
Participants in the intervention arm will be asked to attend a session provided in their language and complete surveys at three time points: baseline (before the intervention), immediately post-intervention, and six-week post-intervention. The surveys aim to assess changes in self-efficacy, knowledge, and health literacy, using questionnaires adapted from the General Self-Efficacy Scale (GSE) [1], the Knowledge of Dementia Risk Reduction (KoDeRR) survey (developed by the University of Tasmania’s Dementia Research and Education Centre) [2], and the Health Literacy Survey European Questionnaire (HLS-EU-Q16) [3]. These surveys will be built on REDCap or Qualtrics and tested by the research team before the intervention.
Community peer educators will be trained by the Lead Investigator and bilingual research assistants on how to deliver the education sessions to community members taking part in the trial. The training will consist of three weekly sessions, each lasting two hours, and will be completed at least two weeks before the intervention begins. Within one week before each educational session (the intervention), a member of the research team, in collaboration with community peer educators, will collect participant responses to the baseline survey (timepoint 1). The training to peer educators will ensure they are equipped to assist in recruiting participants, facilitate the collection of baseline survey responses, and deliver the program in their respective languages. During the workshops, peer educators will also support participants in setting personal health goals, monitor participant progress and provide ongoing support after the workshops, contributing to the program’s overall evaluation.
At the education session, each participant will receive a booklet specifically designed for this study, containing presentation slides of the MindCare program, presenter’s notes, materials for goal setting, and a tip sheet in the form of a fridge magnet as a reminder of dementia prevention tips. The intervention will be monitored through the attendance of two research team members (either in person or online). Participants will be encouraged to take home the materials and respond to the immediate post-intervention survey (timepoint 2) within two days of attending the session.
The evaluation of changes in self-efficacy, knowledge, and health literacy will be conducted approximately six weeks after the intervention (timepoint 3). A member of the research team will contact participants and send them the 6-week follow-up survey to collect quantitative data about knowledge retention, lifestyle changes related to dementia risk reduction, and overall progress on their health goals.
The study will aim to recruit a similar number of participants (approximately 24~30) from each community to ensure equitable representation across the four groups. By delivering the program in participants’ native languages and engaging community peer educators, the MindCare program seeks to ensure cultural relevance and accessibility while promoting dementia risk reduction within CALD communities.

References:
[1] Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user’s portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON.
[2] Eccleston C, Kitsos A, Doherty K. Assessing dementia risk reduction knowledge: development of the KoDeRR instrument (Conference Paper). In: Alzheimer’s Disease Internationditor. 35th Global Conference of Alzheimer’s Disease International: New horizons in dementia. London 2022.
[3] Bergman, L., Nilsson, U., Dahlberg, K., Jaensson, M., & Wångdahl, J. (2023). Validity and reliability of the Arabic version of the HLS-EU-Q16 and HLS-EU-Q6 questionnaires. BMC Public Health, 23(1), 304.
Intervention code [1] 327625 0
Lifestyle
Intervention code [2] 329910 0
Prevention
Comparator / control treatment
The control groups will also include approximately 96 ~ 120 adults aged 40 and over from Arabic-, Vietnamese-, Greek-, and Hindi-speaking communities in Australia who do not undertake the MindCare program but will attend a 90-minute session on general healthy ageing, based on WHO Healthy Ageing guidelines. The deliveries of the healthy ageing program to the control groups will also be conducted by community peer educators. While the same set of surveys will be administered at three-time points - baseline, immediately post-session, and six weeks post-session - to collect quantitative data, the control group will not engage in interactive discussions or goal-setting activities related to dementia risk reduction.
Control group
Active

Outcomes
Primary outcome [1] 339686 0
Self-efficacy of participants, as measured by scores on the General Self-Efficacy Scale (GSE)
Timepoint [1] 339686 0
Baseline, immediate post-intervention (within 2 days) and 6 weeks after baseline
Primary outcome [2] 339688 0
Participants' health-related behaviours and lifestyle for dementia prevention, as assessed as a composite primary outcome
Timepoint [2] 339688 0
6 weeks after baseline
Primary outcome [3] 339687 0
Participants’ knowledge of dementia risk reduction, as measured by scores on the adapted Knowledge of Dementia Risk Reduction (KoDeRR) instrument
Timepoint [3] 339687 0
Baseline, immediate post-intervention (within 2 days) and 6 weeks after baseline
Secondary outcome [1] 440887 0
Participants’ health literacy, as measured by scores on the adapted European Health Literacy Survey (HLS-EU-Q16)
Timepoint [1] 440887 0
Baseline, immediate post-intervention (within 2 days) and 6 weeks after baseline

Eligibility
Key inclusion criteria
Adults aged 40 and over from Arabic-, Vietnamese-, Greek-, and Hindi-speaking communities in Australia and be fluent in one of these languages
Minimum age
40 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)
Randomisation will be done by state (NSW, VIC, SA, WA). Community educators and the partner site staff will be blinded to the allocation.
Randomisation will be undertaken by an independent member of the biostatistical team who is blinded from study personnel.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using minimisation, stratifying by state
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
This is a pragmatic trial conducted in the community.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Group differences at baseline will be compared using mixed linear or logit models incorporating a random effect of site/cluster. The primary outcome analysis will be undertaken on an intention to treat basis, including all participants randomised, regardless of intervention received. The primary outcome will be analysed using the GSE in a mixed-effects model repeated-measures analysis, conducted in Stata 16. Sites will be included in the analyses as a random effect to evaluate and accommodate clustering effects. Comparable methods will be used for the secondary outcomes.
Additional sub-analyses will be undertaken to examine the effects from covariates such as basic demographics such as age (years), sex (male/female), ethnicity, location, educational and economic attainments, country of birth, English proficiency). Where relevant, we will also examine effects of other covariates such as native language proficiency, years lived in Australia, and visa on entry to Australia (e.g. to distinguish economic from humanitarian migrants).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2025
Actual
Date of last participant enrolment
Anticipated
14/03/2025
Actual
Date of last data collection
Anticipated
20/05/2025
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 315437 0
Government body
Name [1] 315437 0
The Commonwealth of Australia - Medical Research Future Fund (MRFF) – Consumer-led research- 2021
Country [1] 315437 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 317506 0
None
Name [1] 317506 0
Address [1] 317506 0
Country [1] 317506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314349 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 314349 0
Ethics committee country [1] 314349 0
Australia
Date submitted for ethics approval [1] 314349 0
13/10/2023
Approval date [1] 314349 0
06/12/2023
Ethics approval number [1] 314349 0
2023-27868-47748-3

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

Contacts
Principal investigator
Name 131270 0
A/Prof Josefine Antoniades
Address 131270 0
School of Humanities and Social Sciences, La Trobe University - Building HU2, Level 3, Room 308 - Plenty Road, Bundoora VIC 3086, Australia
Country 131270 0
Australia
Phone 131270 0
+61 404648063
Fax 131270 0
Email 131270 0
[email protected]
Contact person for public queries
Name 131271 0
Josefine Antoniades
Address 131271 0
School of Humanities and Social Sciences, La Trobe University - Building HU2, Level 3, Room 308 - Plenty Road, Bundoora VIC 3086, Australia
Country 131271 0
Australia
Phone 131271 0
+61 404648063
Fax 131271 0
Email 131271 0
[email protected]
Contact person for scientific queries
Name 131272 0
Josefine Antoniades
Address 131272 0
School of Humanities and Social Sciences, La Trobe University - Building HU2, Level 3, Room 308 - Plenty Road, Bundoora VIC 3086, Australia
Country 131272 0
Australia
Phone 131272 0
+61 404648063
Fax 131272 0
Email 131272 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Only de-identified aggregated data will be made available upon individual request beyond the study findings including de-identified and aggregated data to be disseminated via publications that may arise from this study.



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.