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评估基于移动设备的干预措施以促进新加坡非正式痴呆症照顾者的心理健康:一项试点双臂随机对照试验的研究方案。

Evaluating a mobile-based intervention to promote the mental health of informal dementia caregivers in Singapore: Study protocol for a pilot two-armed randomised controlled trial.

机构信息

Research Division, Institute of Mental Health, Singapore, Singapore.

Department of Geriatric Psychiatry, Institute of Mental Health, Singapore, Singapore.

出版信息

PLoS One. 2024 Jun 24;19(6):e0305729. doi: 10.1371/journal.pone.0305729. eCollection 2024.

Abstract

BACKGROUND

Informal caregivers of persons with dementia (PWD) often suffer adverse impacts on their mental health and require interventions for effective support. As they are often occupied with providing care, web-based interventions could be more convenient and efficient for them. However, there is currently a dearth of evidence-based mobile interventions to enhance the mental well-being of dementia caregivers locally, especially ones that are user-centered and culturally relevant. Hence, having designed an app based on feedback from local dementia caregivers, this study will evaluate the effectiveness of this mobile app in promoting the mental health of informal caregivers of PWD in Singapore.

METHODS

A pilot two-armed randomised controlled trial will be conducted on 60 informal caregivers of PWD recruited via convenience and snowball sampling. Thirty participants will be assigned to the intervention group, while another 30 will be in a waiting-list control group. Questionnaires will be administered at baseline and one month after, with the primary outcome being the difference in the change of depressive symptoms among the two groups.

STATISTICAL ANALYSIS

Primary analyses will follow the intention-to-treat principle and compare changes from baseline to the one-month follow-up time point relative to the control group. A repeated measures ANOVA will be conducted to examine differences between the groups over time.

SIGNIFICANCE

To our knowledge, this is the first study in Singapore that seeks to promote the mental health of informal dementia caregivers through a mobile-based intervention. The findings can inform the development and evaluation of future evidence-based digital interventions for local informal caregivers of PWD to address the gap in availability of such resources for them.

TRIAL REGISTRATION

ClinicalTrials.gov (NCT05551533). Registration date: September 22, 2022.

摘要

背景

痴呆症患者(PWD)的非正式照顾者经常受到心理健康不良影响,需要干预措施来提供有效支持。由于他们经常忙于提供护理,基于网络的干预措施对他们来说可能更加方便和高效。然而,目前缺乏基于证据的移动干预措施来增强本地痴呆症照顾者的心理健康,特别是那些以用户为中心和文化相关的干预措施。因此,在基于当地痴呆症照顾者的反馈设计了一个应用程序后,本研究将评估该移动应用程序在促进新加坡 PWD 的非正式照顾者心理健康方面的有效性。

方法

将通过便利抽样和滚雪球抽样招募 60 名 PWD 的非正式照顾者进行一项试点两臂随机对照试验。30 名参与者将被分配到干预组,而另外 30 名将被分配到等待名单对照组。基线和一个月后将进行问卷调查,主要结果是两组之间抑郁症状变化的差异。

统计分析

主要分析将遵循意向治疗原则,并将与对照组相比,从基线到一个月随访时间点的变化进行比较。将进行重复测量方差分析,以检查随着时间的推移两组之间的差异。

意义

据我们所知,这是新加坡第一项旨在通过基于移动的干预措施来促进非正式痴呆症照顾者心理健康的研究。研究结果可以为为本地 PWD 的非正式照顾者开发和评估未来基于证据的数字干预措施提供信息,以解决此类资源对他们的可用性差距。

试验注册

ClinicalTrials.gov(NCT05551533)。注册日期:2022 年 9 月 22 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ba8/11195940/e0eca356a405/pone.0305729.g001.jpg

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