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社区工作者基于移动健康的干预措施,以支持居家痴呆症患者的家庭照护者:一项整群随机对照试验的研究方案

mHealth-based intervention by community workers to support family caregivers of persons with dementia living at home: study protocol for a cluster randomised controlled trial.

作者信息

Bhardwaj Pankaj, Joshi Nitin Kumar, Gupta Manoj Kumar, Sharma Suresh K, Nebhinani Naresh, Sinha Abhik, Tyrrell Marie, Konradsen Hanne, Craftman Åsa G, Kabir Zarina Nahar

机构信息

Community Medicine and Family Medicine, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.

School of Public Health, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.

出版信息

BMJ Open. 2025 Jan 7;15(1):e087896. doi: 10.1136/bmjopen-2024-087896.

Abstract

BACKGROUND

India is undergoing a significant demographic shift with a growing older population, leading to an anticipated increase in people with dementia. Family caregivers, who are predominantly informal, carry the burden of care within households, facing numerous challenges that impact their well-being. Despite the cultural emphasis on family support, there is a lack of targeted interventions for caregivers in India. The WHO emphasises the importance of caregiver support, and recent advancements in information and communication technology, particularly mobile health (mHealth), offer promising avenues to address this need. This study protocol outlines an Indo-Sweden collaborative effort, funded by Indian Council of Medical Research (ICMR) Forte, to develop and assess the effectiveness of a mHealth application designed to improve caregiving skills, reduce caregiver burden and support family caregivers of persons with dementia.

METHODS AND ANALYSIS

The study will be conducted through a community-based cluster randomised controlled trial in Jodhpur, Rajasthan, with Accredited Social Health Activists (ASHAs) serving as the unit of randomisation. The methodology includes several key phases: a needs assessment to understand caregiver requirements, the development of the mHealth application, comprehensive training for ASHAs and a thorough evaluation of the intervention's impact.The effectiveness of the intervention will be measured through quantitative assessments of stress reduction, depressive symptoms and quality of life improvements, alongside qualitative insights from stakeholders. Additionally, usability and cost analyses will be conducted to evaluate the practicality and economic feasibility of the intervention.The expected outcomes of this study include the creation of a scalable mHealth platform that facilitates remote support, bridges geographical gaps and enhances the well-being of caregivers in India's evolving healthcare landscape.

ETHICS AND DISSEMINATION

Ethical approval has been obtained from the Institutional Ethical Committee of AIIMS Jodhpur (AIIMS/IEC/2022/4245).

TRIAL REGISTRATION NUMBER

Clinical Trials Registry: CTRI/2022/12/048320.

摘要

背景

印度正在经历重大的人口结构转变,老年人口不断增加,预计痴呆症患者数量也会随之上升。家庭护理人员大多是非正式的,他们在家庭中承担着护理负担,面临着诸多影响其福祉的挑战。尽管印度文化强调家庭支持,但针对护理人员的针对性干预措施却很缺乏。世界卫生组织强调了护理人员支持的重要性,而信息和通信技术,特别是移动健康(mHealth)领域的最新进展,为满足这一需求提供了有前景的途径。本研究方案概述了一项由印度医学研究理事会(ICMR)Forte资助的印度 - 瑞典合作项目,旨在开发并评估一款移动健康应用程序的有效性,该应用程序旨在提高护理技能、减轻护理人员负担并支持痴呆症患者的家庭护理人员。

方法与分析

该研究将在拉贾斯坦邦焦特布尔通过基于社区的整群随机对照试验进行开展,以经认证的社会健康活动家(ASHAs)作为随机分组单位。该方法包括几个关键阶段:进行需求评估以了解护理人员的需求、开发移动健康应用程序、对ASHAs进行全面培训以及对干预措施的影响进行全面评估。干预措施的有效性将通过对压力减轻、抑郁症状和生活质量改善的定量评估以及利益相关者的定性见解来衡量。此外,还将进行可用性和成本分析,以评估干预措施的实用性和经济可行性。本研究的预期成果包括创建一个可扩展且便于远程支持的移动健康平台,弥合地理差距,并在印度不断发展的医疗保健环境中提升护理人员的福祉。

伦理与传播

已获得焦特布尔全印医学科学研究所机构伦理委员会(AIIMS/IEC/2022/4245)的伦理批准。

试验注册号

临床试验注册:CTRI/2022/12/048320

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/96fb/11749876/383fe645f2e2/bmjopen-15-1-g001.jpg

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