Effectiveness and Cost-effectiveness of Virtually Delivered Cognitive Stimulation Therapy (vCST) and Online Dementia Carer Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Change in cognitive function
研究概览
简要总结
A multicentre single-blind cluster randomised trial to evaluate the effectiveness and cost-effectiveness of virtually delivered versus in-person cognitive stimulation therapy (CST) and carer support in people living with dementia and carers
详细描述
This is a multicentre, single-blind cluster randomised trial with an aim to evaluate the effectiveness and cost-effectiveness of virtual delivery of CST and carer support in comparison with in-person CST and carer support in Hong Kong Chinese. A total of 156 dyads of people living with dementia and carers will be randomly assigned to one of the four groups: (A) vCST (7 weeks) followed by in-person carer support programme (6 months); (B) in-person CST (7 weeks) followed by in-person carer support programme (6 months); (C) vCST (7 weeks) followed by online carer support programme (6 months); and (D) in-person CST (7 weeks) followed by online carer support programme (6 months). The investigators will measure outcomes at baseline, 7 weeks, and 6 months.
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)
盲法说明
The researchers performing the assessments will be blinded to the intervention group allocation.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having a clinical diagnosis of mild to moderate dementia;
- •having a family carer;
- •living in the community in Hong Kong;
- •able to communicate and understand communication;
- •able to see and hear well enough to participate in a meaningful assessment;
- •the person with dementia and/or his/her carer can provide informed consent
排除标准
- •unable to communicate;
- •unable to participate in intervention due to significant hearing or visual impairment, or other physical or psychiatric conditions
研究组 & 干预措施
vCST + online carer support
vCST followed by online carer support programme
干预措施: online carer support (Behavioral)
f2f CST + online carer support
In-person CST followed by online carer support programme
干预措施: f2f CST (Behavioral)
f2f CST + online carer support
In-person CST followed by online carer support programme
干预措施: online carer support (Behavioral)
vCST + f2f carer support
vCST followed by in-person carer support programme
干预措施: f2f carer support (Behavioral)
vCST + f2f carer support
vCST followed by in-person carer support programme
干预措施: vCST (Behavioral)
f2f CST + f2f carer support
In-person CST followed by in-person carer support programme
干预措施: f2f CST (Behavioral)
f2f CST + f2f carer support
In-person CST followed by in-person carer support programme
干预措施: f2f carer support (Behavioral)
vCST + online carer support
vCST followed by online carer support programme
干预措施: vCST (Behavioral)
结局指标
主要结局
Change in cognitive function
时间窗: From T0 (baseline) to T1 (7 weeks)
Change in cognitive function in persons living with dementia measured using the Chinese version of the Alzheimer's Disease Assessment Scale - Cognitive section (ADAS-Cog) from T0 (baseline) to T1 (7 weeks).
Change in quality of life in persons living with dementia
时间窗: From T0 (baseline) to T1 (7 weeks)
Change in quality of life in persons living with dementia measured using the 13-item Quality of Life in Alzheimer's Disease (QoL-AD) from T0 (baseline) to T1 (7 weeks).
Change in self-efficacy
时间窗: From T1 (7 weeks) to T2 (6 months post-CST)
Change in self-efficacy in dementia carers measured using the Chinese Revised Scale for Caregiving Self-Efficacy (CSE-R) from T1 (7 weeks) to T2 (6 month post-CST).
次要结局
- Change in functioning(From T0 (baseline) to T2 (6 months post-CST))
- Change in perceived positive aspects of caregiving(From T1 (7 weeks) to T2 (6 months post-CST))
- Change in health-related quality of life (carer)(From T0 (baseline) to T2 (6 months post-CST))
- Change in mental wellbeing (PLwD)(From T0 (baseline) to T1 (7 weeks))
- Change in behavioural and psychological symptoms of dementia(From T0 (baseline) to T2 (6 months post-CST))
- Change in health-related quality of life (PLwD)(From T0 (baseline) to T1 (7 weeks))
- Change in carer burden(From T0 (baseline) to T2 (6 months post-CST))
- Change in mental wellbeing (carer)(From T0 (baseline) to T2 (6 months post-CST))
- Change in social functioning(From T0 (baseline) to T1 (7 weeks))