ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

Health promotion/education

Neurological

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]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Single timepoint: at the end of the member-checking process (after workshops' participants viewing the animations)

Primary outcome [2]

E-health literacy will be assessed using eHEALS survey.

Timepoint [2]

Pre-commencement of the intervention component (prior the user-testing)

Primary outcome [3]

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]

At the end of the user-testing (after viewing the animations)

Secondary outcome [1]

N/A

Timepoint [1]

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

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Department of Health, Medical Research Future Fund (MRFF)

Address [1]

Medical Research Future Fund (MRFF) - Australian Government Department of Health
Sirius Building, 23 Furzer Street, Phillip ACT 2606

Country [1]

Australia

Primary sponsor type

Other

Name

National Ageing Research Institute Inc.

Address

Royal Melbourne Hospital, Royal Park Campus, Gate 4, Building 8, 34-54 Poplar Road, Parkville VIC 3052

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Department of Mental Health and Substance Use, World Health Organization (WHO)

Address [1]

WHO Headquarters in Geneva
Avenue Appia 20, 1211 Geneva, Switzerland

Country [1]

Switzerland

Secondary sponsor category [2]

Charities/Societies/Foundations

Name [2]

Dementia Australia

Address [2]

Dementia Australia - Building 21 Macquarie Hospital - Gibson-Denney Centre, 21/120 Coxs Rd, North Ryde NSW 2113

Country [2]

Australia

Secondary sponsor category [3]

Other

Name [3]

Federation of Ethnic Communities Council of Australia (FECCA)

Address [3]

4 Phipps Cl, Deakin ACT 2600

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University HREC

Ethics committee address [1]

Kent Street, Bentley WA 6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/12/2021

Approval date [1]

04/01/2022

Ethics approval number [1]

HRE2022-0004

Summary

Brief summary

Draw-Care aims to improve the lives of culturally and linguistically diverse (CALD) family carers and people living with dementia using culturally-adapted, multilingual animations, digital fact sheets, and a chat-bot, collectively titled “The Draw-Care Intervention”. The first  objective addressed in Study 1 is to develop the digital resources in English and translated versions and undertake checking and user-testing within a series of six online workshops each tackling a different theme related to caring for an individual living with dementia. The workshops therefore use a co-design approach and include carers, clinicians, health and service providers and people living with dementia from CALD backgrounds. The digital resources -- within the scope of this trial are a culturally adapted complement to the iSupport Programme designed by the WHO for carers of people living with dementia.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Bianca Brijnath

Address

National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital VIC 3050

Country

Australia

Phone

+613 8387 2294

Fax

b.brijnath@nari.edu.au

Contact person for public queries

Name

Antonia Thodis (preferred name: Tania)

Address

National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital VIC 3050

Country

Australia

Phone

+61 3 8387 2305

Fax

t.thodis@nari.edu.au

Contact person for scientific queries

Name

Tania Thodis

Address

National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital VIC 3050

Country

Australia

Phone

+61 3 8387 2305

Fax

t.thodis@nari.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided 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?

Doc. No.	Type	Citation	Email	Attachment
14654	Study protocol	Brijnath, 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	383266-(Uploaded-03-02-2022-16-53-55)-Study-related document.pdf
14655	Informed consent form	Brijnath, 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	383266-(Uploaded-03-02-2022-13-21-46)-Study-related document.docx
14920	Informed consent form	Brijnath, 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	383266-(Uploaded-03-02-2022-13-24-20)-Study-related document.docx
14921	Informed consent form	Brijnath, 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	383266-(Uploaded-03-02-2022-13-22-32)-Study-related document.docx
14922	Informed consent form	Brijnath, 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	383266-(Uploaded-10-02-2022-18-20-15)-Study-related document.docx

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.

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