Empowering Dementia Carers With an iSupport Virtual Assistant (e-DiVA) in Asia-Pacific Regional Countries: Protocol for a Pilot Multisite Randomized Controlled Trial

Background Dementia is a global public health priority with an estimated prevalence of 150 million by 2050, nearly two-thirds of whom will live in the Asia-Pacific region. Dementia creates significant care needs for people with the disease, their families, and carers. iSupport is a self-help platform developed by the World Health Organization (WHO) to provide education, skills training, and support to dementia carers. It has been adapted in some contexts (Australia, India, the Netherlands, and Portugal). Carers using the existing adapted versions have identified the need to have a more user-friendly version that enables them to identify solutions for immediate problems quickly in real time. The iSupport virtual assistant (iSupport VA) is being developed to address this gap and will be evaluated in a randomized controlled trial (RCT). Objective This paper reports the protocol of a pilot RCT evaluating the iSupport VA. Methods Seven versions of iSupport VA will be evaluated in Australia, Indonesia, New Zealand, and Vietnam in a pilot RCT. Feasibility, acceptability, intention to use, and preliminary impact on carer-perceived stress of the iSupport VA intervention will be assessed. Results This study was funded by the e-ASIA Joint Research Program in November 2020. From January to July 2023, we will enroll 140 dementia carers (20 carers per iSupport VA version) for the pilot RCT. The study has been approved by the Human Research Committee, University of South Australia, Australia (203455). Conclusions This protocol outlines how a technologically enhanced version of the WHO iSupport program—the iSupport VA—will be evaluated. The findings from this intervention study will provide evidence on the feasibility and acceptability of the iSupport VA intervention, which will be the basis for conducting a full RCT to assess the effectiveness of the iSupport VA. The study will be an important reference for countries planning to adapt and enhance the WHO iSupport program using digital health solutions. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12621001452886; https://tinyurl.com/afum5tjz International Registered Report Identifier (IRRID) PRR1-10.2196/33572


Applicant peer review report
Reviewer # 52

Proposal details
Title e-DiVA (empowering Dementia Carers with an iSupport Virtual Assistant) First named investigator Dr Sarah Cullum (The University of Auckland; Counties Manukau District Health Board)

Health Significance
The proposed research (a) translates the existing WHO iSupport to local languages, and culturally and contextually adapt it to fit the health and social care systems of Australia, Indonesia, New Zealand and Vietnam; (b) develops an iSupport Virtual Assistant smart device app; and (c) ascertains the effects of the iSupport Virtual Assistant on stress, psychological distress and quality of life for informal carers of people living with dementia via a pilot randomised controlled trial. The applicants have demonstrated that the proposed research addresses a significant health issue, has the potential to advance knowledge relevant to health, and that it may contribute to improved health or health outcomes.

Scientific Merit
The rationale for the proposed study is presented well. The aims of the proposed study are clear where they focus on improving mental health and well-being of carers of people with dementia via the adaption of the WHO 'iSupport for Dementia', which is a self-learning online skills training and support program for informal dementia carers, for use in different countries where it is more user-friendly with real time support. Study hypotheses, while only implied in the research proposal, are acceptable. Original findings are expected from the proposed study.

Design and Methods
The study design is adequate. However, there are either insufficient detail for parts of the method and proposed analyses, or the study would benefit significantly by improvements in a one or more of these areas: -Information regarding the translation of iSupport content for local adaption. There is some brief discussion about submission to WHO for quality assurance and the use of focus groups to assess comprehensibility and acceptability of the iSupport. Further information is needed on the validation of iSupport content (i.e. more details on these processes and the analysis to be undertaken etc.).
-Justification of sample size for RCT (why 20 participants per iSupport VA version given the three outcomes -stress, psychological distress and quality of life).
-Clarity on why the waitlist control group will receive access to the iSupport VA three months after randomisation when the intervention group will be using the iSupport VA for six months.
-Details on outcomes measures. Further information on the outcomes measures (i.e. what are the measures, how they measure and why these measures are appropriate) could be provided.
-How will missing data be managed?
-Clarity on data analysis (e.g. what are the expected covariates if any?)

Expertise of Research Team
The research team collectively have the academic qualifications, topic based knowledge, and experience to undertake the proposed research. They have a track record of publication in peer reviewed scientific journals and other professional publications, and/or experience in disseminating research. However, it does not appeared or is unclear whether the lead CIs from each of the four countries has worked together previously and/or experienced in leading / being involved in international collaborations.

Quality of the Partnership
The partnership detailed in this application does provide opportunities for contributions to existing research, training and development of New Zealand researchers and/or collaborative research in this area. The quality of the partnership could be strengthened with a discussion on how early career researchers and pre-doctoral researchers will benefit from this international collaborative research project (e.g. mentorship and potential international research experience).

General comments
The total cost of this project (~1.7 million USD) appears steep for the projected project outcomes. The NZ component seems reasonable at ~$200,000 USD. At minimum, the significance of the research study beyond the proposed project itself should be strengthened to better justified the budget costs.

Applicant peer review report
Reviewer # 55

Proposal details
Title e-DiVA (empowering Dementia Carers with an iSupport Virtual Assistant) First named investigator Dr Sarah Cullum (The University of Auckland; Counties Manukau District Health Board)

Health Significance
The mental health of carers is a health priority.Prevention of mental ill health is better than treatment.If effective, a digital intervention is sustainable, relatively inexpensive.

Scientific Merit
This is an excellent team and my confidence in their capability to deliver this proposal is high.

Design and Methods
A very similar study design is to be implemented in different contexts. This means that its suitability for each one may be compromised in favour of uniformity.

Expertise of Research Team
This is a huge and diverse team. Its scale is its weakness, for example there is scope here for competing egos and global pandemics to de-rail the careful plans. Equally important therefore is the co-ordination of the study.See my general comments.

Quality of the Partnership
This is an exciting network that will enrich NZ research links.

General comments
My main concern about this mammoth programme of work is that the documents I have seen do not explain how it will be coordinated and managed.It appears that this is left to the 'international advisory board'.I would like to know more about the overall project admin function: where is it based, who is accountable, what are the structures and systems for managing data, issuing consortium agreements and holding researchers to account? I would also like some assurance that there is a separate budget line for overall project management, co-ordination and troubleshooting.
I would also like to point out that the initial workshop outline includes training on 'understanding dementia'.Although these are experiential workshops, I wonder why they have taken priority over 'understanding carers', who are the focus of this research.In any educational effort, we need to strike a balance between available online learning and those things which need to be encountered face to face.There is a wealth of free, online learning about dementia.A workshop of this kind would be an invaluable opportunity to listen first-hand to the experiences of dementia carers.

Applicant peer review report
Reviewer # 67

Proposal details
Title e-DiVA (empowering Dementia Carers with an iSupport Virtual Assistant) First named investigator Dr Sarah Cullum (The University of Auckland; Counties Manukau District Health Board)

Health Significance
As noted in the application, dementia is a significant and growing global health issue. The majority of care for people with dementia is undertaken by unpaid family carers who may experience health and economic impacts from their caring. It is vital that family carers are well supported for the sake of their own health and wellbeing; in order to support quality care for people with dementia; and to reduce the impacts on health systems of alternative care for people with dementia.
For Aotearoa New Zealand, this project will develop a culturally adapted version of the WHO iSupport for Dementia in te reo Māori. This is important because with an ageing Māori population, the number of Māori with dementia is expected to grow, and with it, the stress on their family carers.

Scientific Merit
The rationale for the project is clear and it addresses a significant health issue in the collaborating countries and an identified priority of their national dementia plans. The project will take an existing WHO resource (iSupport for Dementia) and adapt it culturally and linguistically for seven population groups within four Asia-Pacific countries. There is a WHO adaptation and implementation guide for doing this type of work and the project has the support of the WHO iSupport team who will assist with training at the initial project workshop and provide ongoing quality assurance.
The proposed pilot RCT will appropriately test the feasibility, acceptability and preliminary efficacy of the app with both quantitative and qualitative methods, providing the basis for a future full RCT to test the effectiveness of this carer support programme.

Design and Methods
The project will adapt an existing WHO resource for dementia carers. In all four countries, this will be undertaken through a co-design process with local carers, NGOs and professionals. Although the proposed resource adaptation work will be done in parallel in the four countries, there are appropriate methodological variations for the different contexts e.g. translation then adaptation of the resource in Vietnam and Indonesia but in New Zealand, adaptation before translation into te reo Māori.
The pilot RCT is appropriately designed to provide initial testing of the usefulness of the iSupport resource and prepare for a full RCT.
I do have two concerns around the design. The first is the sole focus on developing a resource requiring access to the internet and familiarity with using websites or apps. I accept Smartphone use will continue to grow worldwide, including among older people (who will form a significant proportion of carers for people with dementia) but there will still be a group without access to these technologies who may then be excluded from getting much-needed support. Could the researchers collect data on recruitment to the pilot RCT which records how many people are approached who decline to participate because they do not have technology access? (This will only be possible where a clinician will be directly advising carers about the study, in Indonesia, New Zealand and Vietnam and will be most useful in Vietnam where a clinician approach appears to be the only recruitment method.) My second concern is the lack of an Aboriginal or Torres Strait Islander group in the Australian part of the research, given the prevalence of dementia in this group is significantly higher than the general Australian population and they are known to experience poorer health outcomes than other Australians (Radford, K., Lavrencic, L. M., Delbaere, K., Draper, B., Cumming, R., Daylight, G., . . . Broe, G. A. (2019). Factors Associated with the High Prevalence of Dementia in Older Aboriginal Australians. Journal of Alzheimer's disease: JAD, 70(s1), S75-S85. doi:10.3233/JAD-180573). These groups should be high priority for further development of the iSupport VA and any future RCT.
There are three proposed in-person meetings during the project: an initial, five-day, all-of-team training workshop in Australia; a meeting in New Zealand halfway through the project to review the work and plan the pilot RCT; and a final closeout workshop in Australia. Page 18 notes these are subject to international travel being permitted and refers to a Risks section, but this seems to be missing from the proposal. How will the researchers manage the first training workshop in particular if it is not possible to meet in person? How will they manage other possible limitations on or interruptions to the research due to Covid19?

Expertise of Research Team
The project has a very experienced research team. The four country leads all demonstrate strong clinical and research backgrounds in relation to dementia. There is excellent disciplinary breadth among the research team. The inclusion of NGO partners in the research and plans to support their development in research capacity will increase the likely success and impact of the research.

Quality of the Partnership
The project builds on existing collaborations between the researchers from Australia and Vietnam. It also demonstrates partnership with local NGOs which will be vital for both the development and future implementation of this tool.
There is a demonstrated plan for capacity building across the research team and NGO partners, with an initial five-day, allof-team training workshop and other support throughout the project (such as mentoring of newer researchers and joint analysis of qualitative data). The lead PI is an early career researcher. Two Masters and two PhD students will be involved in the project. There is diversity of gender and ethnicity among the research team (excepting indigenous Australians?).

General comments
Thank your for the opportunity to review this interesting proposal.