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【ChiCTR2500098293】线上心理教育项目对衰弱老年人配偶照顾者心理结局的影响：一项试点随机对照研究

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基本信息

登记号

ChiCTR2500098293

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2025-03-05

临床申请受理号

靶点

适应症

无

试验通俗题目

线上心理教育项目对衰弱老年人配偶照顾者心理结局的影响：一项试点随机对照研究

试验专业题目

线上心理教育项目对衰弱老年人配偶照顾者心理结局的影响：一项试点随机对照研究

申办单位信息

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

本研究旨在开发和评估一项心理教育计划对衰弱老年人的配偶照护者的幸福感（主要结果）、照护自我效能感、照顾的积极方面、应对以及心理困扰的影响

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Participants will be randomly assigned to either the intervention or control group at a 1:1 ratio, using block randomisation with a block size of four or six. Group allocation will be determined by pre-generated random identifiers for each site, produced by a computer-generated random number system and prepared in advance by an independent researcher.

盲法

Blinding of participants and interveners is not feasible due to the nature of the intervention; however, to minimise potential bias in outcome assessment, outcome assessors will be blinded to allocation results. Two nursing students will be recruited as research assistants for outcome assessment, receiving a one-hour training session and an assessment of inter-rater reliability before conducting evaluations.

试验项目经费来源

自筹

试验范围

目标入组人数

实际入组人数

第一例入组时间

2025-03-10

试验终止时间

2025-06-15

是否属于一致性

入选标准

(1) Are the primary caregivers for their partner; (2) live with a partner aged 60 years or over (World Health Organization, 2022) who has a health condition with a score of 4 or above using the Groningen Frailty Indicator (Huang et al., 2022); (3) have access to Internet-capable devices; and (4) able to speak and understand Mandarin.；

排除标准

(1)Have visual, auditory and/or cognitive impairments (Abbreviated Mental Test score <=7) (Hernandez et al., 2022); (2) care for patients with terminal illnesses with a predicted survival time (Hui et al., 2014); (3) have anticipated changes in their living arrangements within the next six months, such as a move to long-term care facilities, to prevent any undue influence on the study outcomes; and (4) involve in other psychosocial studies.；

研究者信息

研究负责人姓名

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试验机构

香港中文大学

研究负责人电话

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研究负责人邮编

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