Efficacy and Feasibility of a Multi-component Individualized Telephone-based Support Intervention for Adult-child Caregivers Caring for Parents With Dementia in China: Study Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Caregiver Burden
研究概览
简要总结
This is the first randomized controlled trial exploring the implementation of a multi-component individualized telephone-based support intervention for adult-child caregivers caring for parents with dementia in China. Results hold the potential to inform the further development of family caregiver supportive services.
详细描述
The objectives of this study are to evaluate the efficacy and feasibility of a multi-component individualized telephone-based support intervention (HEART) for adult-child caregivers caring for parents with dementia in China.
The primary hypothesis to test is whether the HEART is more efficacious in reducing caregiver burden than the follow-up as usual (FU) in dementia adult-child caregivers.
Secondary hypotheses include the following:
- The HEART is more efficacious in improving health related quality of life than the FU in dementia adult-child caregivers.
- The HEART is more efficacious in protecting reciprocal Filial Piety than the FU in dementia adult-child caregivers.
- The HEART is more efficacious in relieving CR's behavioral and psychological symptoms of dementia (BPSD) than the FU in dementia adult-child caregivers.
- The HEART group has a higher satisfaction with the intervention than the FU group.
In addition, two research questions will be answered by qualitative data from process evaluation for the feasibility of the HEART intervention. The research questions are as follows:
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
- 否
入选标准
- •Primary caregivers being adult children (age 18 or older) who have spent at least 2 hours per day over the last 3 months caring for a parent with a diagnosis of dementia.
- •Must have telephone access.
- •Caregivers will not end their primary caregiving role within 6 months of study enrollment.
排除标准
- •Cognitive impairment or intellectual disability.
- •Those who are providing care for another relative with chronic physical or mental diseases.
- •Pregnant women (Because it is unlikely that this group would be primary caregivers except in exceptional circumstances, the consideration of which was beyond the scope of this research).
结局指标
主要结局
Caregiver Burden
时间窗: 12 weeks
Caregiver burden will be assessed using the 12-item version of Zarit Burden Interview (12-item ZBI) to measure caregiver burden (Bédard, 2001; Zarit, 1980). Each item is rated on a 5-point Likert scale from 0 (never) though 4 (nearly always), yielding a possible range of 0 to 48. Higher scores indicate greater levels of caregiver burden. This short version and The Chinese version of 12-item ZBI has excellent internal consistency (Cronbachα= 0.87); and is highly correlated with the full measure (r = 0.952) (Lin, 2017; Wang, Yand, \& Hou, 2006).
次要结局
- Caregiver Burden(Baseline, 6 weeks and 24 weeks)
- Health Related Quality of Life(Baseline, 6 weeks, 12 weeks and 24 weeks)
- Satisfaction with and benefits from the Intervention(12 weeks and 24 weeks)
- Reciprocal Filial Piety(Baseline, 6 weeks, 12 weeks and 24 weeks)
- BPSD(Baseline, 6 weeks, 12 weeks and 24 weeks)