【ChiCTR2500095109】A Case-management, Family-centred and Multicomponent Programme to Support Family Caregivers in Caregiving and Mental Health Crisis - Evaluation Study

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基本信息

登记号

ChiCTR2500095109

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

2025-01-02

临床申请受理号

靶点

适应症

mental health problems

试验通俗题目

A Case-management, Family-centred and Multicomponent Programme to Support Family Caregivers in Caregiving and Mental Health Crisis - Evaluation Study

试验专业题目

A Case-management, Family-centred and Multicomponent Programme to Support Family Caregivers in Caregiving and Mental Health Crisis - Evaluation Study

申办单位信息

申请人联系人

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申请人名称

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联系人邮编

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临床试验信息

试验目的

This project aims to develop, implement and evaluate a case-management, family-centred and multicomponent programme to support family caregivers at moderate to high level of caregiving stress and mental distress. For programme development and implementation, we will employ a three-year programme. Specific objectives of this part include: 1) To develop a multi-component intervention for family caregivers, based on case-management and family-centred practice approaches; 2) To complete basic assessments and screen out 300 family caregivers in crisis of caregiving burnout and mental distress; 3) To deliver need-specific services to 300 family caregivers, including education and skills training, individual and family counselling, family-centred activities, volunteer and peer support, service navigation and resource referral; 4) To enhance public awareness, understanding and responses on caregiving burnout and mental distress of caregivers; and 5) To enhance the capacity of volunteers and staffs to evaluate and provide support for caregivers. For programme evaluation, the research team will conduct both process and outcome evaluation. Specific objectives in this part include: 1) To understand associations between caregivers’ basic characteristics and levels of caregiving strain and mental wellbeing; 2) To examine the effectiveness of programme and different components on caregivers’ strain, knowledge and skills, family relationships, social network and support, and mental wellbeing; 3) To evaluate the feasibility and user-satisfaction of programme; and 4) To gain insights of family caregivers, volunteers and service on the barriers and facilitators of programme implementation and sustainability.

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

Stratified sampling will be applied in randomisation to ensure that intervention group and control group are balanced in cases with different risk levels. After baseline assessment, we will stratify participants into two stratums, according to their risk of moderate (ZBI-12 score: 10-20 and HADS score: 8-10) or high (ZBI-12 score: >20 or HADS score: >10) level. Simple randomisation will then be applied to assign participants in each stratum to intervention group or control group, with a ratio of 7:3.

盲法

Single blinding will be applied for outcome investigators.

试验项目经费来源

Suicide Prevention Services Limited; Hong Kong Jockey Club Charities Trust

试验范围

目标入组人数

210;90

实际入组人数

第一例入组时间

2025-01-01

试验终止时间

2027-09-30

是否属于一致性

入选标准

Eligibility of caregivers include: (i) aged 18 or over; (ii) family members who take primary responsibility of caring for their relatives; (iii) caring for older adults aged >=60 years with disabilities, mental disorders or other chronic conditions in care needs; (iv) suffering moderate to high risk of caregiving burnout or mental distress (screening criteria see above), and (v) Chinese ethnicity.；

排除标准

Participants will be excluded if: (i) carers have any physical or mental condition severe enough to interfere their participations in programme activities or assessments; (ii) refuse to join the baseline assessment, or (iii) care-recipients are institutionalized in residential or long-term care homes.；

研究者信息

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试验机构

The Chinese University of Hong Kong

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