Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000358741
Ethics application status
Approved
Date submitted
18/01/2022
Date registered
28/02/2022
Date last updated
13/04/2024
Date data sharing statement initially provided
28/02/2022
Date results provided
13/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Drawing Out Care: Using animation and digital technologies in different languages in family carers and people living with dementia
Scientific title
Draw-Care: The effect of using animation and digital technologies on care burden in Culturally and Linguistically Diverse (CALD) family carers and people living with dementia
Secondary ID [1] 305996 0
Funding Identification Number MRFF2008065
Universal Trial Number (UTN)
Trial acronym
Draw-Care
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 324771 0
Condition category
Condition code
Public Health 322076 322076 0 0
Health promotion/education
Neurological 322220 322220 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Draw-Care aims to improve the lives of family carers and people living with dementia from CALD communities using animations and digital technologies in different languages. Draw-Care is a single trial overall, encompassing three interconnected components. The objective Study 1 is to develop and refine the Draw-Care intervention using a co-design approach.
The Draw-Care intervention will comprise multilingual digital care resources -- animations, digital fact sheets and empathetic chat bot and will be developed based on the WHO's iSupport Lite program targeted to family, informal carers of people living with dementia. iSupport Lite "consists of a set of practical support messages for caregivers..." and has been extracted from iSupport, a more detailed version of the WHO's knowledge and skills online, virtual training program. (https://www.who.int/news/item/06-07-2020-who-launches-isupport-lite). The first objective is to develop and culturally adapt the 'Draw-Care intervention' collaboratively with CALD communities including family carers, people living with dementia, clinicians and service-providers as well as study partners (WHO, Dementia Australia, Federation of Ethnic Communities Council of Australia) using a co-design approach in nine CALD languages--Arabic, Cantonese, Greek, Hindi, Italian, Mandarin, Spanish, Tamil, Vietnamese, plus English. The co-production process includes four steps.
- Step 1: Co-design workshops. A series of six online workshops (1.5 hours duration each) over a three week period. Workshop participants will include a heterogenous group including family carers of people living with dementia from a CALD background, clinicians and service providers. The total number of participants attending over the three week period will be between 42 to 60 in total. Therefore, each individual workshop will comprise 8-10 participants. Each workshop will focus on one key message based on the iSupport Lite Fact Sheets -- 1) Reach Out for Support 2) Taking Care of Yourself 3) Continuity of Care 4) Respond to Change 5) Be Flexible 6) Communicate Effectively.
Participants will be provided with a proposed script and animation storyboard and asked to provide their feedback with the aim of refining the Draw-Care Intervention. To reduce study burden, participants can select the number of workshops they can attend (minimum is one) and are not expected to attend all six. The anticipated heterogeneity of workshop attendees invited to participate from a range of networks and organisations will support a diverse breadth of feedback by which researchers can refine the intervention in Step 3 below.
- Step 2: Interviews. Six to 12 qualitative interviews will be undertaken with people living with dementia. Interviews will be no longer than 30 minutes with a family carer present using a video-conferencing platform consistent with HREC approval.
- Step 3: Creating the Draw-Care intervention -- including 6 short animated films, 6 digital fact sheets and a multilingual chat-bot in English and nine CALD languages.
- Step 4: User-testing: The digital resources will be member-checked with workshop and interview participants and user-tested by CALD carers (n ranging between 27-45). User-testing will be conducted online. Participants will be invited to complete demographics and eHEALTH questionnaires first, then they will complete different tasks on the Draw-Care site. Each testing session will be done on one language of 2-3 people in 20-30 minutes. Once developed and evaluated, the resources comprising the Draw-Care intervention will be collated, further tested and evaluated for clinical and cost-effectiveness in the next component of the Draw-Care trial using a Randomised Controlled Trial (RCT) design (detailed in a separate application).
Intervention code [1] 322515 0
Behaviour
Intervention code [2] 322755 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330098 0
Direct determinants of intervention will be assessed using the Unified Theory of Acceptance and Use of Technology (UTAUT) adapted questionnaire, comprising four components: performance expectancy, effort expectancy, social influence and facilitating conditions. This is a composite primary outcome.
Timepoint [1] 330098 0
Single timepoint: at the end of the member-checking process (after workshops' participants viewing the animations)
Primary outcome [2] 330313 0
E-health literacy will be assessed using eHEALS survey.
Timepoint [2] 330313 0
Pre-commencement of the intervention component (prior the user-testing)
Primary outcome [3] 330314 0
Participants' interaction and use of the interface will be assessed using Hotjar website visualisation software to gain insight into behaviour analytics and gain feedback data.
Timepoint [3] 330314 0
At the end of the user-testing (after viewing the animations)
Secondary outcome [1] 406469 0
N/A
Timepoint [1] 406469 0
N/A

Eligibility
Key inclusion criteria
Step 1: Co-design workshop participant inclusion criteria. Eligible individuals must meet the following:
• Be either CALD carers caring for a person with dementia or a clinician/service provider working with CALD carers;
• Be from a non-English speaking background and speak one of the following languages at home: Arabic, Cantonese, Greek, Hindi, Italian, Mandarin, Spanish, Tamil, and Vietnamese;
• Also speak English;
• Be able to provide consent and participate in workshops; and
• Have access to an internet connection and device such as PC, laptop or tablet/smartphone.
Step 2: Interview: To participate in the qualitative interviews, participants must:
• Have been diagnosed with any type of dementia;
• Be from a non-English speaking background and speak one of the following languages at home: Arabic, Cantonese, Greek, Hindi, Italian, Mandarin, Spanish, Tamil, and Vietnamese;
• Also speak English;
• Be able to provide consent and participate in an interview; and
• If participating in online interview, the participant will need to have access to an internet connection and an appropriate device e.g. laptop, PC, tablet or smartphone.
Step 4: User-testing: To participate in the user testing phase, participants must:
• Be CALD informal / family carers of people living with dementia;
• Be from a non-English speaking background and speak one of the following languages at home: Arabic, Cantonese, Greek, Hindi, Italian, Mandarin, Spanish, Tamil, and Vietnamese;
• Also speak English;
• Be able to provide consent and participate in user testing; and
• Have access to an internet connection and an appropriate device e.g. laptop, PC, tablet or smartphone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who meet the following exclusion criteria are not eligible to participate.
Step 1: Co-design workshops:
• Carers not from a CALD background and clinician/service providers who do not work
with CALD carers.
• Carers who don't speak one of the nine languages at home under investigation in this
trial.
• Are unable to provide consent and participate in one or more of the co-design
workshops,
• Do not have access to an internet connection and device such as PC, laptop or
tablet/smartphone.
Step 2: Interview:
• Have not been formally i.e. medically diagnosed with any type of dementia;
• Are from an English speaking background;
• Not be able to provide consent and participate in an interview; and
• Have no access to an internet connection and an appropriate device e.g. laptop, PC,
tablet or smartphone to participate in an online interview.
Step 4: User-testing:
• Are not from a CALD background.
• Are from an English speaking background;
• Unable to provide consent and participate in user testing; and
• Have no access to an internet connection and an appropriate device e.g. laptop, PC, tablet or smartphone.

Study design
Purpose of the study
Treatment
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
Single group
Other design features

Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
STUDY 1: Step 4-User-testing: Sessions will be analysed via IDA by initial brainstorming occurring at the end of each day of testing to identify usability issues observed and the session data captured by Hotjar. Issue will be ranked as critical (unable to complete task), severe (significant delay or frustration in task completion), or cosmetic (minor issues). Once all sessions are completed, the issues will be inductively separated out and aggregated into larger themes using affinity mapping - a process in which ideas or insights are organised into overarching themes (Joe et al., 2015). At the end of this process, the major themes of the Draw-Care’s usability issues will have been identified as well as users’ suggestions on how to improve the site. Demographic data, eHEALS scores and technology specific scores will undergo data analysis to gain insights into e-health literacy levels of participants, technology usage and sample demographics. SPSS Ver. 27 will be employed to analyse quantitative data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2022
Actual
1/03/2022
Date of last participant enrolment
Anticipated
31/12/2022
Actual
23/03/2023
Date of last data collection
Anticipated
31/03/2023
Actual
23/03/2023
Sample size
Target
117
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310338 0
Government body
Name [1] 310338 0
Australian Government Department of Health, Medical Research Future Fund (MRFF)
Country [1] 310338 0
Australia
Primary sponsor type
Other
Name
National Ageing Research Institute Inc.
Country
Australia
Secondary sponsor category [1] 311717 0
Other
Name [1] 311717 0
Department of Mental Health and Substance Use, World Health Organization (WHO)
Country [1] 311717 0
Switzerland
Secondary sponsor category [2] 311719 0
Charities/Societies/Foundations
Name [2] 311719 0
Dementia Australia
Country [2] 311719 0
Australia
Secondary sponsor category [3] 311721 0
Other
Name [3] 311721 0
Federation of Ethnic Communities Council of Australia (FECCA)
Country [3] 311721 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309997 0
Curtin University HREC
Ethics committee address [1] 309997 0
Ethics committee country [1] 309997 0
Australia
Date submitted for ethics approval [1] 309997 0
06/12/2021
Approval date [1] 309997 0
04/01/2022
Ethics approval number [1] 309997 0
HRE2022-0004

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 116122 0
Prof Bianca Brijnath
Address 116122 0
National Ageing Research Institute PO Box 2127 Royal Melbourne Hospital VIC 3050
Country 116122 0
Australia
Phone 116122 0
+613 8387 2294
Fax 116122 0
Email 116122 0
b.brijnath@nari.edu.au
Contact person for public queries
Name 116123 0
Antonia Thodis (preferred name: Tania)
Address 116123 0
National Ageing Research Institute PO Box 2127 Royal Melbourne Hospital VIC 3050
Country 116123 0
Australia
Phone 116123 0
+61 3 8387 2305
Fax 116123 0
Email 116123 0
t.thodis@nari.edu.au
Contact person for scientific queries
Name 116124 0
Tania Thodis
Address 116124 0
National Ageing Research Institute PO Box 2127 Royal Melbourne Hospital VIC 3050
Country 116124 0
Australia
Phone 116124 0
+61 3 8387 2305
Fax 116124 0
Email 116124 0
t.thodis@nari.edu.au

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?

TypeCitationLinkEmailOther DetailsAttachment
Study protocolBrijnath, B., Nguyen, T., Antoniades, J., Varghese, M., Loganathan, S., Enticoff, J., Hlis, D., Mortimer, D., Wickramasinghe, N., Gilbert, A.S., Dow, B., Cooper, C., Xiao, L.D., Dang, H., Thodis, A. (2021) Protocol Draw-Care: Using animation and digital technologies to support Culturally and Linguistically Diverse (CALD) family carers and people living with dementia. Parkville. Australia: National Ageing Research Institute t.thodis@nari.edu.au Study-related document.pdf
Informed consent formBrijnath, B., Nguyen, T., Antoniades, J., Varghese, M., Loganathan, S., Enticoff, J., Hlis, D., Mortimer, D., Wickramasinghe, N., Gilbert, A.S., Dow, B., Cooper, C., Xiao, L.D., Dang, H., Thodis, A. (2021) Draw-Care Participant Information Statement: Family carers--Study 2 Trial the intervention.  t.thodis@nari.edu.au Study-related document.docx
Informed consent formBrijnath, B., Nguyen, T., Antoniades, J., Varghese, M., Loganathan, S., Enticoff, J., Hlis, D., Mortimer, D., Wickramasinghe, N., Gilbert, A.S., Dow, B., Cooper, C., Xiao, L.D., Dang, H., Thodis, A. (2021) Draw-Care Participant Information Statement: Family carers--Study 2 Trial the intervention.  t.thodis@nari.edu.au Study-related document.docx
Informed consent formBrijnath, B., Nguyen, T., Antoniades, J., Varghese, M., Loganathan, S., Enticoff, J., Hlis, D., Mortimer, D., Wickramasinghe, N., Gilbert, A.S., Dow, B., Cooper, C., Xiao, L.D., Dang, H., Thodis, A. (2021) Draw-Care Participant Information Statement: Family carers--Study 2 Trial the intervention.  t.thodis@nari.edu.au Study-related document.docx
Informed consent formBrijnath, B., Nguyen, T., Antoniades, J., Varghese, M., Loganathan, S., Enticoff, J., Hlis, D., Mortimer, D., Wickramasinghe, N., Gilbert, A.S., Dow, B., Cooper, C., Xiao, L.D., Dang, H., Thodis, A. (2021) Draw-Care Participant Information Statement: Family carers--Study 2 Trial the intervention.  t.thodis@nari.edu.au Study-related document.docx


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Thodis A, Dang T-H, Antoniades J, et al. Improving... [More Details]
Study results articleYes Thu Ha Dang, Antonia Thodis, Nalika Ulapane, Josef... [More Details]

Documents added automatically
No additional documents have been identified.