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
- 2
- 主要终点
- Change in quality of life in persons living with dementia
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
结局指标
主要结局
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).
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).
次要结局
- 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 functioning(From T0 (baseline) to T2 (6 months post-CST))
- 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))