BrainLive Connect: Non-professional Delivered Cognitive Stimulation Therapy for People Living With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
研究概览
简要总结
The goal of this mixed method study is to evaluate whether the volunteer-led Cognitive Stimulation Therapy (CST) under the BrainLive Connect programme is effective for improving cognitive function and quality of life of people living with dementia (PLwD).
The main question it aims to answer are:
• Do PLwD receiving the BrainLive Connect service show better cognitive function and quality of life than those receiving usual care?
Researchers will compare BrainLive Connect service to usual care to see whether the intervention leads to better outcomes.
Participants will:
- Receive either 7 weeks of BrainLive Connect sessions delivered by trained volunteers or continue receiving usual care.
- Be assessed at baseline (T0), post-intervention (7 weeks; T1), and 1 month follow up (11 weeks; T2).
- Take part in semi-strucutred interviews post-intervention to provide feedback on implementation and areas for improvement.
详细描述
The research design is a non-randomized controlled trial (nRCT), involving 260 PLwD in the experimental group (BrainLive group) who will receive 7 weeks of BrainLive Connect service, and another 260 PLwD in the control group (Care-as-usual group) who will receive usual care for comparison. Participants of the experimental group will be recruited by our partnering NGOs, and those of the control group will be from both the partnering NGOs and network of HKU. Outcomes of PLwD and their carers will be measured at three time points: intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2), to assess the lasting effects of the volunteer-led CST. During the evaluation period, participants in the control group will receive standard care and support.
The BrainLive Connect service aimed at maintaining cognitive functions, and improving quality of life (Primary outcomes); and reducing distressed behaviour, improving social functioning, reduced carer burden, improving daily functioning, and preference for ageing-in-place (Secondary outcomes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •PLwD: Hong Kong residents, mild to moderate dementia, either having i) a formal diagnosis, or 2) suspected dementia reported by care professionals and screened by Montreal Cognitive Assessment (MoCA).
- •Family carers: self-identified as the primary carer of the PLwD.
排除标准
- •Unable to communicate and participate in interviews/training/intervention due to hearing impairment, visual impairment, or other conditions.
研究组 & 干预措施
Non-professional delivered CST
Participants will receive 14-session Cognitive Stimulation Therapy (CST) delivered by trained volunteers, with two sessions per week over a period of 7 weeks
干预措施: Cognitive Stimulation Therapy (CST) (Behavioral)
Usual social care
Participants will receive usual social care and support provided by elderly care service units operated by non-governmental organisations, including but not limited to care services, psychosocial intervention, and social activites.
干预措施: Usual Care (Other)
结局指标
主要结局
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
时间窗: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Possible range: 0 -70, with higher scores indicate more impairment
Quality of Life-Alzheimer's Disease (QoL-AD)
时间窗: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Possible range: 13 - 52, with higher scores indicate better quality of life
次要结局
- Neuropsychiatric Inventory Questionnaire (NPIQ)(Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2))
- Social functioning in Dementia Scale (HKSF-DEM: carer rating)(Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2))
- Care burden (Zarit Burden Interview short version, 12-item)(Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2))
- The Lawton Instrumental Activities of Daily Living (IADL)(Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2))
- Preference for ageing-in place (self-developed scale)(Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2))
- Preparation of ageing in-place (self-developed scale)(Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2))
- The Montreal Cognitive Assessment subscale (MoCA subscale)(Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2))
研究者
Choy Chak Pui Jacky
Research Assistant Professor
The University of Hong Kong