Drawing Out Care: Using animation and digital technologies in different languages in family carers and people living with dementia - a randomised controlled trial.

INTERVENTION: 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 g CONDITION: Dementia; ; Dementia Public Health ‐ Health promotion/education Neurological ‐ Dementias PRIMARY OUTCOME: 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).[‐ Baseline; ‐ 6 weeks post‐intervention commencement; ‐ 12 weeks post‐intervention commencement (primary timepoint); ; ] SECONDARY OUTCOME: Productivity and activity impairment assessed using the WPAI:CG (Giovannetti et al, 2009). This is the secondary outcome of study 2. ; [‐ Baseline ; ‐ 6 weeks post‐intervention commencement ; ‐ 12 weeks post‐intervention commencement ; ] 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. ; ; [‐ Baseline ; ‐ 6 weeks post‐intervention commencement ; ‐ 12 weeks post‐intervention commencement] 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.[‐ 6 weeks post‐intervention commencement ; [‐ Baseline ; ‐ 6 weeks post‐intervention commencement ; ‐ 12 weeks post‐intervention commencement ; ; ‐ 6 weeks post‐intervention commencement ; ‐ 12 weeks post‐intervention commencement ; ] Resource Utilisation in Dementia (RUD) (Wimo et al, 2013). This is the secondary outcome of study 2. ; [‐ Baseline ; ‐ 6 weeks post‐intervention commencement ; ‐ 12 weeks post‐intervention commencement ; ‐ 12 weeks post‐intervention commencement] 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. ; ‐ 12 weeks post‐intervention commencement ] 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.[‐ 6 weeks post‐intervention commencement ; ] 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.[‐ Baseline ; ] 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. ; ; ; [‐ Baseline ; ‐ 6 weeks post‐intervention commencement ; ‐ 12 weeks post‐intervention commencement ; ; ; ] 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.