Play Intervention for Dementia for Promoting Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adjusted Post-test Score of Montreal Cognitive Assessment Scale After 2 Months of Intervention
研究概览
简要总结
This study intends to use Play Intervention for Dementia (PID) to promote cognitive functions of people with early to moderate dementia.
This is a cluster randomized controlled trial aims to recruit 38 participants from two study sites. Participants will be randomly allocated into intervention or wait-list controlled groups. Both groups will receive the same content of PID programme at different time. The PID consists of 12 weekly sessions. Each session lasts for 45-75 minutes. The PID will be facilitated by a play specialist, trained elderly volunteers, and centre staffs. Cognitive functions will be evaluated with Montreal Cognitive Assessment, Fuld Object Memory Evaluation and Modified Verbal Fluency Test, conducted by a trained research assistant blinded to group allocation. Centre staffs (not involved in the PID) will be interviewed. Every alternate session will be video-taped for understanding the experience of the participants in the PID programme.
详细描述
Methodology To investigate the feasibility of using Play Intervention for Dementia for enhancing the cognitive functions of people with dementia.
Research objectives
- To examine the feasibility of using Play Intervention for Dementia for enhancing cognitive functions.
- To explore the effects of Play Intervention of Dementia on cognitive functions.
- To examine the experience of participating in the play intervention by people with dementia.
Research design This study is a feasibility study, designed as a cluster randomized controlled trial. Two study sites (day care centres) have agreed to join this project and will be randomly allocated to either PID group, or wait-list control group.
A mixed methods design will be employed to address the three research objectives. To evaluate the feasibility of Play Intervention, information about the ease of recruitment, attendance, occurrence of adverse events during play intervention will be collected. Staff perceptions upon play intervention will be explored through semi-structured interview. To explore the preliminary effects of Play Intervention, participants' cognitive functions will be measured at baseline (T0), after 2 months (T1), and post intervention (T2). To examine the experience of Play Intervention by people with dementia, every alternate session will be videotaped for analysis.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community dwelling, at the age of 65 or above
- •With a medical confirmed diagnosis of any type of dementia (such as Alzheimer's disease, vascular dementia, etc.).
- •At the stage of early to moderate dementia, at the stage of 4-6 screened by Global Deterioration Scale
排除标准
- •Unable to sit independently and participate in table activities
- •Physically unstable
- •Dislikes group activity
结局指标
主要结局
Adjusted Post-test Score of Montreal Cognitive Assessment Scale After 2 Months of Intervention
时间窗: At Baseline, after 2 months (T1)
The Hong Kong version of the 11-item Montreal Cognitive Assessment scale was used to measure the global cognitive functions of the participants. The scores range from 0 to 30, and lower scores refer to lower levels of cognitive function. The scores reported are the adjusted post-test mean scores using its baseline measures as a covariate in ANCOVA.
次要结局
- Adjusted Post-test Score of Fuld Object Memory Evaluation - Total Storage Score(At Baseline, after 2 months (T1))
- Adjusted Post-test Score of the Modified Verbal Fluency Test(At Baseline, after 2 months (T1))
研究者
Dr Daphne Cheung
Dr.
The Hong Kong Polytechnic University