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Trial registered on ANZCTR


Registration number
ACTRN12622000382774
Ethics application status
Approved
Date submitted
17/02/2022
Date registered
4/03/2022
Date last updated
13/04/2024
Date data sharing statement initially provided
4/03/2022
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 - a randomised controlled trial.
Scientific title
Draw-Care: A randomised controlled trial on 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] 306396 0
Funding Identification Number MRFF2008065
Universal Trial Number (UTN)
Trial acronym
Draw-Care
Linked study record
This study is the second component of the overall Draw-Care Trial and is related to the first component recently assigned ACTRN 12622000358741.

Health condition
Health condition(s) or problem(s) studied:
Dementia 325227 0
Condition category
Condition code
Public Health 322627 322627 0 0
Health promotion/education
Neurological 322628 322628 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. Draw-Care is a single trial encompassing three interconnected study components. Study 2 is a randomised control trial (RCT) designed to test the Draw-Care intervention developed by co-design methodology in Study 1 and evaluate the effect on the primary (carer burden) and secondary outcomes (mood and quality of life respectively). In turn, Study 3 aims to evaluate cost-effectiveness of the Draw-Care intervention within the same participant cohort enrolled into the RCT.
STUDY 2: The digital RCT will evaluate the clinical effectiveness of the Draw-Care intervention complement of resources--developed in Study 1, in reducing burden experienced by family carers up to 12 weeks after receipt of the resource, relative to the control group. The research question to be addressed is whether the culturally-adapted multilingual Draw-Care intervention reduces carer burden--the primary outcome measure. The RCT will be a 12-week wait-list RCT with a parallel design conducted with CALD family carers (total target sample size = 194; 1:1 ratio) of Arabic, Cantonese, Greek, Hindi, Italian, Mandarin, Spanish, Tamil and Vietnamese-speaking backgrounds. Study 3 will in turn, evaluate the cost-effectiveness of the Draw-Care intervention from a societal perspective and the direct costs of delivering the intervention within the target community.
The key points of the Draw-Care Intervention RCT -- Study 2 and 3 are highlighted below.
1) 194 participants will be recruited through national networks servicing Australia's CALD communities. Participants will be randomly assigned to one of the two groups i.e. intervention group vs the control group. We endeavor to achieve a balanced sample of carers from the different language backgrounds within the scope of this trial.
2) Outcomes will be assessed at baseline, 6 weeks and 12 weeks post-baseline. Baseline covariates include -- carer characteristics (age in years, sex, ethnicity, location, educational and economic attainments, country of birth, English proficiency and relationship with the care recipient) and care recipients characteristics (age in years, sex, country of birth, English proficiency, dementia duration, type and severity and behavioural and psychological symptoms). Where relevant, data will be captured on native language proficiency, years lived in Australia, visa on entry (e.g. to discern economic from humanitarian migrants).
3) The Draw-Care Intervention to be tested includes six messages consistent with the English version of the WHO iSupport Lite fact sheets which co-developed and co-designed in Study 1 and delivered as six culturally-adapted, multilingual animations, a chat bot and six digital fact sheets.
4) 194 carers will be recruitment using NARI's CALD Research Engagement Network. Partner organisations will extend a letter of invitation to potential participants. Interested individuals will be screened by the Draw-Care Project Manager and/or Research Assistant.
5) Following signed consent and completion of baseline questionnaires, carers will be randomised separately for each Draw-Care language to either the intervention group or the waiting list control group (1:1 ratio). This is done separately for each language to create balance in the intervention and control arms of the trial.
6) The intervention group of carers (n=97) will use the Draw-Care Intervention for a 12 week testing period immediately following randomisation. Carers will receive a link by researchers by email containing a username/password to access the website and in turn, the Draw-Care intervention. After logging in and prior to accessing the animations, the multilingual chat bot will help them identify and prioritise their needs. Animations will be presented in order of their selections to ensure the intervention is tailored to their needs. All participants will receive a monthly email or phone text message from the research team to support adherence and engagement with the testing phase.
7) Simultaneously, during the testing period of the intervention group, carers randomised to the active waitlist group will receive access to a pdf version of a comic in their preferred language relating to dementia care. Control group participants will be informed that they receive access to the second component of the intervention i.e. Draw-Care after they have completed the 12-week assessment after which all wait-list carer participants can access the Draw-Care Intervention. By design, to minimise performance bias, a benign deception will be applied. All participants irrespective of group allocation will be informed that there are two components to the intervention they will receive, that the order in which the components are received is randomised and that researchers want to better understand the effects of each.
8) During the 12 week assessment testing period, participants will be asked not to discuss the intervention and the assessor will also be blinded to the order of components received by the intervention and the control group. After 12 weeks, all participants will be given access to the Draw-Care intervention and online comics on dementia care.
9) By design, the length of each animation within the Draw-Care intervention is approximately two to three minutes. Each fact sheet--a single A4 size, will take no more than 5 minutes to read. At a minimum, participants must access and engage with the Draw-Care intervention at least once during the 12-week testing period. There is no maximum limit on how many times participants can access the intervention during the 12 weeks.
10) To support participants' adherence and engagement, all participants will receive a monthly email or text message from the research team (Project Manager or RA1/2) and a friendly reminder by phone to complete assessments.
11) To complement the quantitative analysis of the Draw-Care intervention, a sub-set of participants, i.e. carers, (target n=55 in total) will take part in qualitative interviews designed to capture their views and experience using the Draw-Care intervention. Interviews will be undertaken via video conferencing or by phone and audio-recorded (with consent), transcribed and analysed.
12) Within this part of the Draw-Care trial, data will be captured to facilitate Study 3, a trial-based economic evaluation of cost-effectiveness of the Draw-Care intervention. This will be measured by analysis of questionnaire responses from the same cohort of participants already enrolled into the RCT.
Intervention code [1] 322832 0
Behaviour
Intervention code [2] 322833 0
Treatment: Other
Comparator / control treatment
STUDY 2: Randomised Control Trial of the Draw-Care Intervention. The comparator or active control group for the RCT are CALD family carers (n=97) who will not have access to the Draw-Care intervention until after the 12 week test period is completed. However, this group will be provided with access to existing digital information related to dementia care in the form of comics in their language of choice. The comics are a readily available resource previously developed by the Moving Pictures Project (National Ageing Research Institute and Curtin University). We estimate the in-language short comic may take approximately five minutes to read. Participants can refer to, and read the comic ad libitum throughout the 12-week period.
Control group
Active

Outcomes
Primary outcome [1] 330428 0
Care burden (for family carers) assessed using the Zarit Burden Interview (ZBI). This is the primary outcome of study 2 and 3.
ZBI is a widely used tool to assess items related to carer burden by five point scale with response options ranging from never to nearly always. The tool has been deemed reliable and valid among the target population (Zarit SH, et al. Relatives of the impaired elderly: Correlates of feelings of burden. Geront 1980).
Timepoint [1] 330428 0
- Baseline
- 6 weeks post-intervention commencement
- 12 weeks post-intervention commencement (primary timepoint)
Secondary outcome [1] 406168 0
Carer mood assessed using the Centre for Epidemiologic Studies Depression Scale (CES-D) screening questionnaire for clinical depression (Lewinsohn et al, 1997). This is the secondary outcome of study 2.
Timepoint [1] 406168 0
- Baseline
- 6 weeks post-intervention commencement
- 12 weeks post-intervention commencement
Secondary outcome [2] 406169 0
Quality of life of the carer and the person with dementia assessed by WHOQOL-Bref (WHOQOL Group, 1998) and of a sub-group of carers (Italian and Spanish speaking) using the CarerQoL-7D (W.B.F Brouwer et al, 2006). This is the secondary outcome of study 2.
Timepoint [2] 406169 0
- Baseline
- 6 weeks post-intervention commencement
- 12 weeks post-intervention commencement
Secondary outcome [3] 406171 0
Productivity and activity impairment assessed using the WPAI:CG (Giovannetti et al, 2009). This is the secondary outcome of study 2.
Timepoint [3] 406171 0
- Baseline
- 6 weeks post-intervention commencement
- 12 weeks post-intervention commencement
Secondary outcome [4] 406172 0
Resource Utilisation in Dementia (RUD) (Wimo et al, 2013). This is the secondary outcome of study 2.
Timepoint [4] 406172 0
- Baseline
- 6 weeks post-intervention commencement
- 12 weeks post-intervention commencement
Secondary outcome [5] 406173 0
Quality-adjusted life-years (QALYs) in both carers and patients, calculated based on baseline, 6 week and 12 week data using EQ-5D-5L utilities mapped from WHOQOL-Bref data (Wee et al., 2018). Supplementary analyses will be conducted in the sub-group for which CarerQol are available (W.B.F.Brouwer et al., 2006). This is the secondary outcome of study 3.
Timepoint [5] 406173 0
- Baseline
- 6 weeks post-intervention commencement
- 12 weeks post-intervention commencement
Secondary outcome [6] 406174 0
Direct costs of delivering the intervention and control conditions will be calculated based on administrative records and fidelity/adherence data - Resource Utilization in Dementia (RUD) (Wimo et al., 2013). This is the secondary outcome of study 3.
Timepoint [6] 406174 0
- 6 weeks post-intervention commencement
- 12 weeks post-intervention commencement
Secondary outcome [7] 406175 0
Health service utilisation for both the carer and patient within the trial period will be calculated based on carer self-report, using the Resource Utilisation in Dementia (RUD) instrument. This is the secondary outcome of study 3.
Timepoint [7] 406175 0
- 6 weeks post-intervention commencement
- 12 weeks post-intervention commencement
Secondary outcome [8] 406748 0
Productivity gains/losses will be calculated using the friction cost approach (Werner B. F. Brouwer & Koopmanschap, 2005) based on WPAI:CG data for each carer. This is the secondary outcome of study 3.
Timepoint [8] 406748 0
- Baseline
- 6 weeks post-intervention commencement
- 12 weeks post-intervention commencement

Eligibility
Key inclusion criteria
STUDY 2: RCT of the Draw-Care intervention and Study 3: Evaluation of the cost-effectiveness of the Draw-Care intervention comprise the same cohort of participants. Eligible individuals must meet all of the following criteria.
• Be an informal carer of a person living with dementia from a CALD background, aged 18 and over;
• Be from a non-English speaking background and can speak one of the following languages: Arabic, Cantonese, Greek, Hindi, Italian, Mandarin, Spanish, Tamil, and Vietnamese;
• Also speak English;
• Be able to provide consent and participate in the trial;
• Have access to an internet connection and appropriate device such as laptop, PC, Tablet or Smartphone;
• Have not participated in study 1 in either phase i.e. co-design workshops or the user-testing.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
STUDY 2-Draw-Care trial and STUDY 3-Evaluate the cost-effectiveness of the intervention i.e. the same cohort of participants.
• CALD carers who participated in the preceding study 1 (in either the workshops or the
user-testing).
• Informal carers who are English-speaking only and not from a CALD background.
• Unable to provide consent and participate in the trial;
• Have no access to an internet connection and appropriate device such as laptop, PC,
Tablet or Smartphone; and
. Participated in study 1 in either phase i.e. co-design workshops or the user-testing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Carers will be randomised separately for each Draw-Care language version to one of two groups, either the intervention group or waiting list control group. This process will be done by a clinical trials service (off-site), which is blinded from study personnel.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using blocks sized four will be performed for equal allocation of participants into either the intervention of the control group throughout the duration of the enrolment period for Study 2.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Study 2: RCT of the Draw-Care intervention -- has a wait-list design (intervention and control groups, ratio 1:1). The intervention group will use the Draw-Care intervention for 12 weeks immediately following randomisation. The wait-list control group will receive later access to the intervention 12 weeks after randomisation.
Study 3: Evaluate the cost-effectiveness of the Draw-Care intervention. This evaluation will be conducted from data captured from the same cohort of participants from Study 2.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
STUDY 2-Trial the Draw-Care (RCT)
ZBI is our primary outcome measure of carer burden and in turn, used for the power calculation. Based on normative data from carers of people with dementia (Zarit et al., 1980), we expect an effect size (Cohen d) of 0.40 measured between baseline and the 12 week endpoint. Assuming an alpha of .05 and a statistical power (1-beta) of .80 in a one-tailed test, we will need 78 respondents in each of the conditions, resulting in a total of 156 participants. Calculation of the sample size was carried out with Stata V16. Assuming 25% attrition the total sample is 194 participants. To evaluate our primary outcome, we will use mixed effects generalised linear regression. Random effects will account for repeated measures from participating carers. Time-point (baseline, 6wks and 12wks) and intervention/control group will be specified as fixed. Other independent variables will be considered for inclusion in the model as they may influence the primary outcome and require adjustment for confounding (e.g. age, sex, ethnicity, location, country of birth, English proficiency, and relationship to person with dementia).
Fidelity/adherence data will be derived from analytics, which will examine participant’s hours of viewing, completeness of viewing of animations, frequency/timing of viewing, and interactions with the chat-bot. Acceptability of the intervention is pre-specified as >70% of participants rating the intervention ‘completely acceptable’.

STUDY 3: Cost-effectiveness: trial-based economic evaluations of the cost-effectiveness of the intervention from a societal perspective (as compared to a control condition approximating usual care) will be conducted. In line with the main analysis, the primary outcome for the trial-based analysis will be carer burden as measured by the ZBI at 6- and 12-weeks. The secondary outcome for the economic evaluation will be quality-adjusted life-years (QALYs) in both carers and patients, calculated based on baseline, 6 week and 12 week data using EQ-5D-5L utilities mapped from WHOQOL-Bref data (Wee et al., 2018). Supplementary analyses will be conducted in the sub-group for which we have CarerQoL (W. B. F. Brouwer et al., 2006) utilities, calculating patient QALYs using mapped EQ-5D-5L utilities and calculating carer QALYs using CarerQoL utilities. Treatment effects with respect to the ZBI will be estimated as per the main effectiveness analysis. Treatment effects with respect to total QALYs to 12 week follow-up will be estimated using one-part generalized linear models (GLM); controlling for carer and patient WHOQoL-Bref scores at baseline and specifying appropriate variance and link functions (Glick, Doshi, Sonnad, & Polsky, 2014).
Direct costs of delivering the intervention and control conditions will be calculated based on administrative records and fidelity/adherence data - Resource Utilization in Dementia (RUD) (Wimo et al., 2013). Health service utilisation for both the carer and patient within the trial period will be calculated based on carer self-report at 6 and 12 weeks. Productivity gains/losses will be calculated using the friction cost approach (Werner B. F. Brouwer & Koopmanschap, 2005) based on WPAI:CG data for each carer at baseline, 6 and 12 weeks. Base-case analyses will exclude productivity gains/losses due to the risk of double-counting (Shiroiwa, Fukuda, Ikeda, & Shimozuma, 2013) but we will conduct supplementary analyses to evaluate the potential for bias due to separate inclusion/exclusion of productivity gains/losses. Given the likely structure of our data and the advice of Buntin and Zaslavsky (Buntin & Zaslavsky, 2004), treatment effects with respect to total cost will be estimated using a one-part GLM models with gamma variance function and a log link (rather than transformed OLS or two-part models); controlling for patient and carer characteristics at baseline. Results will be expressed as (i) cost per point improvement on the ZBI at trial end, and (ii) cost per QALY gained. We will summarise sampling error and parameter uncertainty using the bootstrap acceptability method to calculate confidence intervals and generate cost-effectiveness acceptability curves (Glick et al., 2014).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
10/08/2023
Date of last participant enrolment
Anticipated
12/07/2024
Actual
Date of last data collection
Anticipated
4/09/2024
Actual
Sample size
Target
194
Accrual to date
61
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310749 0
Government body
Name [1] 310749 0
Australian Government Department of Health, Medical Research Future Fund (MRFF)
Country [1] 310749 0
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] 311976 0
Other
Name [1] 311976 0
Department of Mental Health and Substance Use, World Health Organization (WHO)
Address [1] 311976 0
WHO Headquarters in Geneva
Avenue Appia 20, 1211 Geneva, Switzerland
Country [1] 311976 0
Switzerland
Secondary sponsor category [2] 311977 0
Other
Name [2] 311977 0
Dementia Australia
Address [2] 311977 0
Dementia Australia - Building 21 Macquarie Hospital - Gibson-Denney Centre, 21/120 Coxs Rd, North RydeNSW 2113
Country [2] 311977 0
Australia
Secondary sponsor category [3] 311978 0
Other
Name [3] 311978 0
Federation of Ethnic Communities Council of Australia (FECCA)
Address [3] 311978 0
4 Phipps Cl, Deakin ACT 2600
Country [3] 311978 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310328 0
Curtin University HREC
Ethics committee address [1] 310328 0
Kent Street, Bentley WA 6102
Ethics committee country [1] 310328 0
Australia
Date submitted for ethics approval [1] 310328 0
06/12/2021
Approval date [1] 310328 0
04/01/2022
Ethics approval number [1] 310328 0
HRE2022-0004

Summary
Brief summary
The Draw-Care study aims to improve the lives of culturally and linguistically diverse (CALD) family carers and people living with dementia using animations, digital fact sheets, and a multilingual chat-bot, collectively titled “The Draw-Care Intervention”. The three primary objectives of the study are addressed in three interconnected components comprising the overall trial.
In Study 2, the intervention will be trialled and tested for effectiveness in reducing care burden experienced by carers of people living with dementia -- both of a CALD background up to 12 weeks after they receive the resources and will be compared with an active control group who won't receive the resources at the same time.
The third component of the trial overall is to evaluate cost-effectiveness of the intervention from a societal perspective compared to a control which models usual standard care.
The outcomes of the Draw-Care study are significant and measurable in terms of effectiveness of the resources developed, that is, 1) whether care burden is reduced 2) whether there are improvements in family carer's mood and quality of life 3) whether there are improvements in the quality of life for the person living with dementia. A range of online questionnaires including previously validated tools and interviews with carers and people living with dementia will be used to capture exposures and views and experiences using the Draw-Care intervention complement of resources.
Trial website
Trial related presentations / publications
Public notes
The benign deception is detailed in the study protocol (attached to this application) and has been approved by the HREC from Curtin University. Briefly, this aspect of the methodology involves all participants being informed by the researchers that there are two components to the Draw-Care intervention they will receive and that the order in which they receive these interventions is randomised, and that we want to understand the effects of each component. They will receive the first component upon completion of baseline assessment (intervention/active control) but will not receive access to the second component until they have completed the 12-week assessment. During this time, participants will also be asked not to discuss the intervention with anyone. After 12 weeks, all participants irrespective of whether they are in the intervention or active waitlist control group will be given access to the Draw-Care intervention and online comics for dementia care.

Contacts
Principal investigator
Name 117258 0
Prof Bianca Brijnath
Address 117258 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital VIC 3050
Country 117258 0
Australia
Phone 117258 0
+613 8387 2294
Fax 117258 0
Email 117258 0
b.brijnath@nari.edu.au
Contact person for public queries
Name 117259 0
Dr Antonia Thodis (preferred name: Tania)
Address 117259 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital VIC 3050
Country 117259 0
Australia
Phone 117259 0
+61 3 8387 2305
Fax 117259 0
Email 117259 0
t.thodis@nari.edu.au
Contact person for scientific queries
Name 117260 0
Dr Tania Thodis
Address 117260 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital VIC 3050
Country 117260 0
Australia
Phone 117260 0
+61 3 8387 2305
Fax 117260 0
Email 117260 0
t.thodis@nari.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
15041Study 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 383550-(Uploaded-10-02-2022-19-03-16)-Study-related document.docx
15042Informed 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-CareParticipant Information Statement: Family carers--Study 2 Trial the intervention. t.thodis@nari.edu.au 383550-(Uploaded-10-02-2022-19-04-01)-Study-related document.docx



Results publications and other study-related documents

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