Refinement, Pilot Implementation, and Testing of the Carer Support Needs Assessment Tool Intervention (CSNAT-I) in Hong Kong Palliative Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Caregiver burden
研究概览
简要总结
In this hybrid Type 1 effectiveness-implementation pilot randomized controlled trial, 60 caregivers will be randomized into either the CSNAT-I group or usual care. Preliminary effectiveness outcomes include caregiver burden, distress, and health-related quality of life. Preliminary implementation outcomes include feasibility, fidelity, appropriateness, acceptability, cost of the intervention, as well as barriers and facilitators to intervention implementation. Quantitative data will be analyzed using descriptive analysis and linear mixed effects model, while qualitative data using thematic analysis. The CSNAT-I is expected to be preliminarily effective in improving caregiver outcomes and implementable in Hong Kong palliative care context, which will serve as the foundation for a large trial before integration into daily practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults ≥18 years old;
- •family members taking a primary role in patient care at home as nominated by the palliative cancer patient;
- •ability to communicate in Chinese.
排除标准
- •paid caregivers;
- •unable to complete the questionnaire due to mental impairment determined by physicians.
结局指标
主要结局
Caregiver burden
时间窗: From enrollment to the end of intervention at 4 weeks
13-item Caregiver Strain Index (CSI), each item with 1 ("yes") or 0("no") responses. The total score ranges from 0 to 13 and a higher score represents greater caregiver burden.
次要结局
- Caregiver distress(From enrollment to the end of intervention at 4 weeks)
- Health-related quality of life(From enrollment to the end of intervention at 4 weeks)
- Reach(Through study completion, an average of 6 months)
- Implementation(Through study completion, an average of 6 months.)
- Enablers and barriers to access, effectiveness, implementation, adoption, and maintenance(Up to 6 months)
研究者
Dr CHENG Huilin
Assistant Professor
The Hong Kong Polytechnic University