Effects of An Advance Care Planning Programme for Persons With Early Dementia And Their Family Caregivers in the Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Change in advance care planning engagement
研究概览
简要总结
Advance care planning (ACP) has been widely advocated for persons with early stage dementia (PWEDs). This proposed study attempts to promote the uptake of ACP for this population and their family caregivers in the community and to examine the effects of an ACP programme "Have a Say" for this population. It is hypothesized that participants in the intervention group will be more engaged in ACP and their dyadic concordance on end-of-life care preference with their family caregivers will be significantly higher than that in the control group.
详细描述
This study aims to evaluate the effects of an advance care planning (ACP) programme "Have a Say" for persons with early stage dementia (PWEDs) and their family caregivers in the community. A randomized controlled trial with repeated blinded outcome assessment will be conducted to assess the effects of an ACP programme on dyads of PWEDs and their family caregivers recruited from elderly community centres. Individuals who have a clinical diagnosis of any form of dementia at the early stage or have a Global Deterioration Score (GDS) 3 or 4 will be eligible to this study. Participants in the experimental group will receive a 4-session ACP programme. It includes an educational component, guided reflection and ACP discussion through a series of group-based activity and dyadic discussion delivered by trained ACP facilitator and guided by an ACP booklet. Dyads of participants will be provided with information about the trajectory of dementia, their future healthcare needs and caring options. Their values and care preferences on future care will be elicited in a consistent manner. They will be supported to have an individualized ACP discussion. Individuals assigned to the control group will receive attention-control health talks. The primary study outcome is the ACP engagement level of PWEDs. Secondary outcome is the dyadic concordance on end-of-life care preference. Adverse outcomes such as depression and caregivers' burden will also be evaluated. Data collection will be conducted at baseline, immediately after, and one-month after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to the group assignment and research question.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being Chinese,
- •being a Cantonese speaker,
- •having a formal diagnosis of any form of dementia at the early stage, or having a Global Deterioration Scale score 3-4,
- •having a designated family caregiver in direct contact and willing to participate in this study.
排除标准
- •non-communicable,
- •mentally incompetent,
- •received an ACP intervention,
- •have previously signed an advance directive,
- •have other life-limiting chronic illnesses.
- •A family caregiver involved in primary responsibility for caring and care-related decisions for the PWED will also be recruited. Paid caregivers are to be excluded.
结局指标
主要结局
Change in advance care planning engagement
时间窗: Outcome will be measured at baseline, immediately after intervention, and 1-month after
The validated 9-item Advance Care Planning (ACP) Engagement Survey will be used to measure the engagement of PWED in the ACP process. Each item is measured on a five-point Likert scale and average 5-point scores will be calculated. It is originated from a longer version of 82 items measuring factors affecting the process of ACP engagement, including knowledge, contemplation, self-efficacy, and readiness. This shorter version reported sound psychometric properties and able to detect change across a broad range of ACP behaviours and ACP domains, with Cronbach's alpha =0.84, cross-sectional correlations =0.85, and delta correlations =0.68. The Chinese version of the ACP Engagement Survey is validated and reported sound psychometrical properties. This scale is composed of self-efficacy subscale and readiness subscale. Higher score reflects a higher level of ACP engagement.
次要结局
- Change in dyadic concordance of preference on end-of-life care(Outcome will be measured at baseline, immediately after intervention, and 1-month after)
- change in depression(Outcome will be measured at baseline, immediately after intervention, and 1-month after)
- Change in caregivers' stress(Outcome will be measured at baseline, immediately after intervention, and 1-month after)
研究者
Ms Cheryl Yeung Chi Yan
Principal Investigator
Hong Kong Metropolitan University