【ChiCTR2300074683】Application of caregiver intervention program for Chinese dementia patients’ caregiver in Hong Kong

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基本信息

登记号

ChiCTR2300074683

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2023-08-13

临床申请受理号

靶点

适应症

Dementia Caregiver Stress

试验通俗题目

Application of caregiver intervention program for Chinese dementia patients’ caregiver in Hong Kong

试验专业题目

Psychology

申办单位信息

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联系人邮编

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临床试验信息

试验目的

To examine the locally adapted START dementia caregiver intervention and examine its clinical effectiveness in reducing depressive and anxiety symptoms and caregiver's stress

试验分类

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试验类型

随机平行对照

试验分期

Ⅰ期

随机化

Random Allocation Software (software for randomization) will be used by principal investigator for the randomization process. After recruiting the participants, they will be randomized into treatment and control group.

盲法

Nil

试验项目经费来源

Nil

试验范围

目标入组人数

实际入组人数

第一例入组时间

2023-08-07

试验终止时间

2024-08-31

是否属于一致性

入选标准

The current study targets to recruit caregiver with dementia person in their family. The dementia person could be either taking care of the dementia person by the family or partially taking care by day care centre/other form of similar service in Hong Kong. The caregiver has to provide stable care towards the dementia person and regard themselves as a caregiver. Caregiver who lives with the dementia person or live separately could both be accepted. Caregivers are required to have basic literacy ability in Chinese to read the manuals and questionnaires. With reference to the previous research insight, we would recruit participants with a level of distress in caregiving in order to enhance the relevance of the therapy to the caregivers and to prevent the floor effect in the results. The short form of Zarit Burden Scale (Tang et al., 2016) would be used as a screening tool on the level of distress of the caregivers. With reference to the previous research on the scales (Yu et al., 2019; Bédard et al, 2001, & Tang et al., 2016), the cut-off score would be 19 or above.；

排除标准

Due to the nature of the intervention programme, caregivers with dementia person staying in elderly home or having an active plan of letting the dementia person to be institutionalized will be excluded in the current study. Besides, caregivers with significant mental disorders e.g. schizophrenia or significant health conditions e.g. cancer, which affects their participation and application of the skills learnt in the programme, will also be excluded. Caregivers who are non-Chinese speaking or fail to read the manuals are not likely to be beneficial by the programme, hence they will not be recruited. Lastly, if the dementia person has significant difficulty to give any conscious response, the caregiver would be regarded as not suitable to be a participant of the study.；

研究者信息

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试验机构

Nil

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