Using Digital Media to Improve Dementia Care in India: Protocol for a Randomized Controlled Trial

Background India is undergoing a demographic transition characterized by population aging and is witnessing a high dementia rate. Although nearly 7 million people live with dementia in India, dementia awareness is poor, and current resources addressing dementia care are basic and often incomplete, duplicated, or conflicting. To address this gap, this study aims to use digital media, which has had a massive technological uptake in India, to improve dementia care in India. Objective The objective of this paper is to describe an intervention study design that examines the feasibility and acceptability of Moving Pictures India, a digital media resource to improve dementia care in India. Methods This study employs a mixed methods design and is divided into 4 phases: (1) video interviews with Indian caregivers and health professionals; (2) coproduction of resources; (3) pilot randomized controlled trial (RCT); and (4) dissemination and analytics. The pilot RCT will follow an experimental parallel group design with 2 arms aiming to assess the impact, feasibility, and acceptability of the developed resources. The primary outcome measures for the pilot RCT will be feasibility and acceptability, while the secondary outcome measures will be caregiver burden, mood, and quality of life. Results This study received funding from the Alzheimer’s Association in the United States in July 2021. In 2023, we will enroll 60 dementia caregivers (40 caregivers in the intervention arm and 20 in the control) for the pilot RCT. The study has been approved by the National Institute of Mental Health and Neuro Sciences Ethics Committee (26th IEC (BEH.SC.DIV.)/2020-21 dated November 11, 2020); the Health Ministry's Screening Committee, India (proposal ID 2020-10137); the Curtin University Human Research Ethics Committee (approval number HRE2020-0735); and the NARI Research Governance Office (site-specific approval dated March 17, 2021). Conclusions This protocol is designed to deliver unique, coproduced, and evidence-based media resources to support caregivers of persons with dementia in India and other countries aiming to utilize digital media for dementia care. If the intervention is found feasible and acceptable, postpiloting analytics and qualitative feedback will be used to develop an implementation trial to evaluate the effectiveness of the potential low-risk high-benefit intervention in practice. Trial Registration Clinical Trials Registry-India CTRI/2021/01/030403; http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50794 International Registered Report Identifier (IRRID) DERR1-10.2196/38456

C. Quality of the Work Plan. (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score). : This ambi ous, 3 year long project is complex, well-developed and ghtly designed to achieve stated objec ves and project goal.
An important voice is missing in the study sample iden fied for par cipa on in qualita ve interviews. The story of demen a and demen a care cannot be told without the voices of those who have demen a, who experience receiving personal care from a family member or stranger and who may be influenced by effects of cultural beliefs and norms about demen a. Few informal or formal caregivers ask or consider how persons with demen a experience the loss of cogni on and memory, becoming a care receiver or comfort level in needing to ask for what they want or need. Adding the voices of care receivers can contribute valuable informa on and insight to videos on demen a and demen a caregiving.
Mobility and safety are two cri cal elements in maintaining the func onal and cogni ve capacity of a person with demen a especially if the person is an older adult. It will be important for mobility and safety to be discussed in caregiver interviews and considered for subsequent inclusion in the proposed videos.

D. Resources/Budget
Ques on Score: 1 Excep onal D. Quality and Adequacy of Available Resources and Budget.. (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score). : Resources available to implement this pilot study are extensive and comprehensive involving interna onal mul disciplinary professionals, agencies, and organiza ons. The project team is an excep onal resource with each member bringing a high level of experience and exper se to the project. Individual resumes are comprehensive documen ng professional background and exper se with special a en on to relevance to current project. A major strength is the experience mul ple project members bring from a similar project conducted in Australia.
The resource budget requests support dollars within the allo ed grant budget with extensive supplemental and in kind supports in personnel and equipment budgets, significantly expanding available resources. The final budget is sufficient to meet project goals.

E. Impact-Risk
Ques on Score: 1 Excep onal E. The Alzheimer's Associa on is interested in funding inves ga ons that will have a major impact on the field of Alzheimer's and related diseases, including projects that may have an element of risk. However, such projects MUST contain the poten al to fuel significant gains and/or insights. Based on this asser on, if this project were successful, could it have a major impact on advancing the field of demen a research? Please select the score which best reflects your determina on.. (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score).: There is minimal risk to study par cipants.
Success of this project will bring about significant changes, na onally and interna onally, in the way people caring for those with demen a, those with demen a and the general public access mely, accurate informa on on demen a. Study results will generate increased a en on to ensuring informa on is culturally relevant.

Reviewer Role: Reviewer (1457)
Cri que Score: 4 Very Good Reviewer Summary: This is a solid proposal. The workplace is outlined well with outcomes and deliverables. Applicant is well qualified and supported by solid team. Not sure approach is best for the popula on for most impact.

A. Significance
Ques on Score: 4 Very Good A. Significance of the Ques on Being Studied.. (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score). (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score).: Ques on is significant however would like to have seen more about why moving pictures is the best way to impact this audience and lead to outcomes studied.

B. Applicant
Ques on Score: 4 Very Good B. Applicant Informa on. (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score). : Seems appropriate for the the research outlined and has team in place to support the study. Previous experience and publica ons support the outlined work.

C. Work Plan
Ques on Score: 4 Very Good C. Quality of the Work Plan. (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score). : Workplan is well outlined with outcomes and deliverables. Valid and reliable measures outlined. Suppor ve interdiscplinary team in place to accomplish work.

D. Resources/Budget
Ques on Score: 3 Excellent D. Quality and Adequacy of Available Resources and Budget.. (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score). : The budget and resources are appropriate for the work outlined in the proposal. Addi onal team members seem appropriate to assist with the proposed work.

E. Impact-Risk
Ques on Score: 4 Very Good E. The Alzheimer's Associa on is interested in funding inves ga ons that will have a major impact on the field of Alzheimer's and related diseases, including projects that may have an element of risk. However, such projects MUST contain the poten al to fuel significant gains and/or insights. Based on this asser on, if this project were successful, could it have a major impact on advancing the field of demen a research? Please select the score which best reflects your determina on.. (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score).: Seems innova ve as it leverages India's growing digital presence -340.2 million Indians are smartphone users, es mated to grow by 84% -to promote an interven on that is accessible to those who have low literacy, live in rural areas, and/or are me poor.

Reviewer Role: Reviewer (365049)
Cri que Score: 2 Outstanding Reviewer Summary: Overall, the research team is highly experienced with a strong history of collabora on and publica ons. Prior experience heading the Australia Moving Pictures is a huge advantage to the proposed study for several reasons described above. The ques on is significant -improving demen a care at home -and the means of dissemina on (digital media) is highly appropriate (accessible, cost-effec ve) for this popula on. The deliverable is highly adaptable for other communi es and will be a valuable model for other media-based interven ons to improve demen a home care in culturally relevant ways.

A. Significance
Ques on Score: 2 Outstanding A. Significance of the Ques on Being Studied.. (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score). (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score).: The applicant aims to produce 9 short films accessible via smartphone and that focus on 9 domains related to demen a symptoms, clinical care experience, and prac cal caregiver informa on to help improve family-based demen a care in India. Up to 50 interviews from health providers (25) and caregivers (25) inform the culturally relevant digital media storyboards. Storyboards are member-checked, and resul ng videos are community-evaluated using surveys for feasibility and acceptability. The problem the applicant addresses is significant because India has the world's highest growing demen a rate and, coupled with a high es mate (90%) of people diagnosed with demen a are unaware of their condi on. The use of smartphones to access videos is appropriate, given the high rate of current and projected smartphone users (84%) in 2020, and its lower cost compared to television and print media. Applicant understands value of establishing a firm cultural understanding, rather than assump on, for improved stakeholder and target audience buy-in, acceptance, and impact. Caregiver learning is cri cal for quality demen a care.

B. Applicant
Ques on Score: 1 Excep onal B. Applicant Informa on. (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score). : The team demonstrates prior collabora on, including co-publishing and clinical training in demen a and digital media work. Two PIs have exper se in demen a care and mul cultural communi es, and another PI has exper se in crosscultural mental health and healthcare -understanding methodologies to inves gate cultural differences across the region will be cri cal for producing culturally relevant videos, for poten ally greater impact. PI exper se also in communica ons and technology, digital dissemina on, storyboarding, all essen al for the proposed work. Further, team will have assistance from the Moving Pictures Australia team. Overall, the team's exper se seems well-rounded and appropriate to successfully implement the study's culturally sensi ve digital media aims regarding demen a care. Ellis has several publica ons on disability media work. Antoniades recently received her PhD in 2017 -her prior experience on the Moving Pictures project will be a great asset, as well as other team members' history of collabora on with the Australia Moving Pictures project. The team includes a current director of the Australian Na onal Ageing Research Ins tute, with over a decade of experience and publica ons in demen a health literacy, demen a community care and caregiver understanding of demen a symptoms and more; a research director with over a decade of research in adult home care, non-pharmacological interven ons, demen a, and more; Kent and Ellis have an extensive history of co-authorship in digital media studies and disabili es; Loganathan has a decade of work covering demen a and mental health in India, including an online training for caregivers which will be valuable experience for the present proposed caregiver-focused digital media study. Varghese is Head of Geriatric Psychiatry at his ins tu on in India, with over 30 years experience in Alzheimer's and mild cogni ve impairment, pathological aging in India. Brijnath has a background in Anthropology and public health, which will lend a cri cal lens to the cultural piece of this study -relevance, uptake, response, etc. She has published on the culture of demen a care in India, and is PI of Moving Pictures Australia. Her cultural exper se is a cri cal factor in the Moving Pictures Australia's adaptability to India. This mul disciplinary team has broad exper se in a number of areas appropriate to the proposed study -demen a care, caregiver learning, technology-based interven ons and dissemina on, anthropology.

C. Work Plan
Ques on Score: 2 Outstanding C. Quality of the Work Plan. (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score). : This study follows a validated design -Moving Pictures Australia. Involving par cipants in the produc on process has precedence in the Australian Moving Pictures study, so there should be good baseline understanding among the research team of an cipated barriers to circumvent for more sustained and successful involvement and interac on with study par cipants. Applicant understands value of establishing a firm cultural understanding, rather than assump on, for improved stakeholder and target audience buy-in, acceptance, and impact. The areas of focus are appropriate, prac cal, and important for developing quality home care: Demen a, help-seeking pathways, the importance of self-care, useful ques ons to ask health professionals, and how to care for a person with demen a at home on a daily basis. The study follows an established methodology (UK Medical Research Council guidance for the development and evalua on of complex interven ons), which applicant's Australian partners have used prior in the Moving Pictures Study. Applicant noted that efforts will be made for sociological diverse sample of carer interviewees, but that most are women and of middle and upper class. Having a clearer outline of how researchers will ensure that low-income family carers are included in their study would strengthen the sample diversity, and may improve the cultural relevance of the digital media the research team aims to produce, as low-income families are likely to have less educa on and financial ability to provide quality care for those living with demen a, and may thus benefit more by having access to digital media. However, some explana on of how many low-income families have access to digital media would be helpful, or how the research team plans to ensure dissemina on to popula ons with decreased access would be helpful. Similarly, a clearer explana on of the range of sociological diversity of carers at the place of recruitment (NIMHANS) would be helpful.
In Year 1 (objec ve 1), up to 50 Interviews will be done by two research team members. It is unclear how many team members, if more than the two interviewers, will be conduc ng analysis. Would be ideal if team members who did not conduct interviews were conduc ng analysis, or to have the interviewers analyze those interviews they did not conduct. This may be ght meline to recruit, interview, and analyze qualita ve data of up to 50 interviews. In Year 2 (objec ve 2), storyboarding will take place, meaning that all interviews and analysis must be completed. Would be good to know if this same rapid meline was successful in the Moving Pictures Study.
The nominal group technique for cultural appropriateness and cri cal review of storyboard will include a wide range of people for a good, thorough review process. Subsequent member checking by interviewees will be cri cal, and the applicant has proposed this, showing their commitment to center the carer perspec ve that will, as stated before, likely have significant influence on how well digital media is received, shared, and understood, poten ally for be er care and care-seeking. Reserving a por on of evalua on surveys to be done in person would may help ensure a more diverse range of socioeconomic sample. For older carers, online and even telephone interviews may be less comfortable or accessible (online). No argument was made for why eligible community members had to be literate, as digital media is a great way to educate those who are illiterate, and illiterate people also use smartphones.
Year 2/3 (Objec ve 3) will be to evaluate the impact of these resources on care and carer burden. Primary outcomes are feasibility and acceptability of a full RCT. 40 par cipants in interven on arm, and 20 controls -receive care and access to digital media; receive care and access to healthy living info (non-demen a) -this seems appropriate for this study at this stage of development.
The applicant provided good argument for ability to recruit caregivers in a short period of me based on prior study experience. The project offers nine videos that are culturally-specific, scalable, and cost-effec ve. There is careful a en on paid to understanding caregiver perspec ves and knowledge gaps regarding demen a care. This study seems highly transferrable to other communi es and cultures.

D. Resources/Budget
Ques on Score: 2 Outstanding D. Quality and Adequacy of Available Resources and Budget.. (Applicants appreciate feedback. Please provide a brief paragraph as jus fica on for each score). : The budget seems appropriate for the proposed ac vi es and travel, par cularly with the addi onal NARI dona on of $5000 for travel. Resources seem adequate -recruitment will be greatly facilitated by the 50,000 dollars of clinical staff to assist with interview and pilot recruitment. The applicant has thorough knowledge of financial requirements to successfully carry out a study given prior experience on the Australian Moving Pictures study.

E. Impact-Risk
Ques on Score: 2 Outstanding E. The Alzheimer's Associa on is interested in funding inves ga ons that will have a major impact on the field of Alzheimer's and related diseases, including projects that may have an element of risk. However, such projects MUST contain the poten al to fuel significant gains and/or insights. Based on this asser on, if this project were successful, could it have a major impact on advancing the field of demen a research? Please select the score which best reflects