Brijnath Bianca, Baruah Upasana, Antoniades Josefine, Varghese Mathew, Cooper Claudia, Dow Briony, Kent Mike, Loganathan Santosh
National Ageing Research Institute, Parkville, Australia.
Institute of Human Behaviour & Allied Sciences, Delhi, India.
JMIR Res Protoc. 2022 Jun 2;11(6):e38456. doi: 10.2196/38456.
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.
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.
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.
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).
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.
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.
印度正在经历以人口老龄化为主的人口结构转变，痴呆症发病率很高。尽管印度有近700万人患有痴呆症，但人们对痴呆症的认知较差，目前用于痴呆症护理的资源基础且往往不完整、重复或相互冲突。为了弥补这一差距，本研究旨在利用在印度已大量普及的数字媒体来改善印度的痴呆症护理。
本文的目的是描述一项干预研究设计，该设计检验《印度动画》（Moving Pictures India）这一改善印度痴呆症护理的数字媒体资源的可行性和可接受性。
本研究采用混合方法设计，分为4个阶段：（1）对印度护理人员和卫生专业人员进行视频访谈；（2）共同制作资源；（3）试点随机对照试验（RCT）；（4）传播与分析。试点RCT将采用实验平行组设计，分为两组，旨在评估所开发资源的影响、可行性和可接受性。试点RCT的主要结局指标将是可行性和可接受性，次要结局指标将是护理人员负担、情绪和生活质量。
本研究于2021年7月获得美国阿尔茨海默病协会的资助。2023年，我们将为试点RCT招募60名痴呆症护理人员（干预组40名护理人员，对照组20名）。该研究已获得国家心理健康和神经科学研究所伦理委员会（2020年11月11日第26次IEC（BEH.SC.DIV.）/2020 - 21号）、印度卫生部筛查委员会（提案编号2020 - 10137）、科廷大学人类研究伦理委员会（批准号HRE2020 - 0735）以及NARI研究治理办公室（2021年3月17日特定地点批准）的批准。
本方案旨在提供独特、共同制作且基于证据的媒体资源，以支持印度及其他旨在利用数字媒体进行痴呆症护理的国家中痴呆症患者的护理人员。如果发现该干预措施可行且可接受，试点后的分析和定性反馈将用于开展一项实施试验，以评估这一潜在低风险高效益干预措施在实际应用中的效果。
印度临床试验注册中心CTRI/2021/01/030403；http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50794。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/38456。
