Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 4, 2022
Open Peer Review Period: Apr 3, 2022 - Apr 19, 2022
Date Accepted: May 2, 2022
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The Moving Pictures India Study: A pilot randomised control trial using digital media to improve dementia care in India
ABSTRACT
Background:
India is undergoing a demographic transition characterised by population ageing and is witnessing a high dementia rate. Although, around 4.4 million people live with dementia in India, dementia awareness is poor and current resources addressing dementia care are basic and often incomplete, duplicated, and/or conflicting. To address this gap, the current study aims to use digital media, which has had a massive technological uptake in India, to improve dementia care in India.
Objective:
To describe the design of an intervention study that examines the feasibility and acceptability of a digital media resource (Moving Pictures India) to improve dementia care in India.
Methods:
The primary objectives of the study are: to video interview Indian carers and health professionals; to co-produce nine short films on dementia care; to pilot the resources developed to assess feasibility and acceptability; and finally, to disseminate the resources after incorporating post-pilot changes (if any) and use the analytics and feedback to develop a larger implementation trial. The study employs a mixed methods design and is divided into four phases as per the objectives: (i) video interviews with Indian carers and health professionals; (ii) co-production of resources; (iii) pilot randomised controlled trial (RCT); and (iv) dissemination and analytics. The pilot RCT will follow an experimental parallel group design with two arms aiming to assess impact, feasibility and acceptability of the developed resources. The primary outcome measures for the pilot RCT will be feasibility and acceptability. Secondary outcome measures for the pilot RCT will be carer burden, carer mood and carer quality of life.
Results:
This study was funded by the Alzheimer’s Association US in July 2021. In 2023, we will enroll 60 dementia carers (40 carers for the intervention arm and 20 for the control) for the pilot RCT. The study has been approved by the National Institute of Mental Health and Neurosciences (NIMHANS) Ethics Committee (NIMHANS/26th IEC (BEH.SC.DIV.)/2020-21 dated 11.11.2020), Health Ministry's Screening Committee, India (HMSC; proposal ID 2020-10137), the Curtin University Human Research Ethics Committee (HREC; Approval number: HRE2020-0735), and the NARI Research Governance Office (Site specific approval dated 17.03.2021)
Conclusions:
This study protocol is designed to deliver unique, co-produced, evidence-based media resources to support carers of persons with dementia in India and other countries aiming to utilize digital media for dementia care. Analytics and qualitative feedback post-piloting will be used, if the intervention is found feasible and acceptable, to develop an implementation trial to evaluate the effectiveness of the potential low-risk high-benefit intervention in practice. Clinical Trial: The trial was registered with the Clinical Trials Registry-India (Trial Registration No. CTRI/2021/01/030403). Registered on Jan 12, 2021.
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