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

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.