A Stand-alone Therapeutic Music-with-Movement Programme for People With Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
The number of people living with cognitive impairment is increasing at an exponential rate. More than 100,000 older people are living with dementia in Hong Kong. Alarmingly, about 60% of long-term care residents or day-care centre users are living with dementia, nearly all of whom experience anxiety, depression, or other behavioural and psychological symptoms that place heavy demands on healthcare support and jeopardize their quality of life.
A standalone Music-with-Movement system is developed by integrating innovative and communication technology to facilitate the delivery of an evidence-based music-with-movement intervention. The technology employed are music library, 6-axis motion-sensing music instruments, wireless charging, and RFID.
This study aims to evaluate the changes in health outcomes (cognition, psychosocial well-being and perceived support) of older adults after receiving the service delivered by the trained staff using the standalone music-with-movement system.
详细描述
Methods:
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Aims and objectives:
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to evaluate the feasibility of the system supporting staff from elderly care institutes in leading musical activities (i.e., recruitment, retention, and acceptability);
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to evaluate the engagement of the participants in the intervention; and
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to preliminarily examine the health conditions of older adults with cognitive impairment.
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Methods:
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Design: Single-group pre-and-post-test design
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Participants: Older adults with cognitive impairment.
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Setting: Elderly care institutes, such as daycare centres, community centres, and/or nursing homes.
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Sample size: 750 participants.
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Outcomes: Recruitment rate, attrition rate, acceptability, any adverse events, engagement in the intervention, health outcomes (social support, frailty, health-related QoL, MoCA).
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Data analysis strategies:
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Ethical consideration: Approval has been obtained from the University (HSEARS20211026009)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Older adults with cognitive impairment
- •In a stable medical condition
排除标准
- •With critical medical or psychiatric problems
- •Those with uncorrectable hearing impairment
结局指标
主要结局
Recruitment Rate
时间窗: through study completion, an average of 3 year
Recruitment rate-defined as the proportion of eligible participants (following screening) who agreed to take part in the study (calculated as number of participants recruited (numerator)/number of eligible participants (denominator)). Reference: Easpaig, B. N. G., Zhai, J., Gray, R., Brown, E., \& Bressington, D. (2022). Recruitment, attrition and intervention completion in clinical trials of psychosocial interventions involving people with early and emerging psychosis: a systematic review protocol. BMJ open, 12(9), e060863.
Intervention completion rate
时间窗: through study completion, an average of 3 year
Intervention completion rate - defined as the proportion of participants who completed the allocated intervention (for at least 70% attendance). Calculated as number of participants allocated to the intervention that completed the minimum attendance (numerator)/number of participants allocated to treatment (denominator).
Attribution Rate
时间窗: through study completion, an average of 3 year
Attrition rate -defined as the proportion of participants at defined study points who discontinued the intervention or were lost to follow-up (calculated as number of participants that withdraw (numerator)/number of participants randomised (denominator)). Attrition rates will be calculated as three points: after randomisation, during the intervention and at final follow-up. Reference: Easpaig, B. N. G., Zhai, J., Gray, R., Brown, E., \& Bressington, D. (2022). Recruitment, attrition and intervention completion in clinical trials of psychosocial interventions involving people with early and emerging psychosis: a systematic review protocol. BMJ open, 12(9), e060863.
次要结局
- Change in Montreal Cognitive Assessment 5-minute (MoCA)(6 months)
- Change in Frail Scale(6 months)
- Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score(6 months)
- Change in Health-related Quality of Life (EQ-5D-3L)(6 months)
- Change in Neuropsychiatric Symptoms - Informant-based(6 months)
- Engagement during the intervention(3 months)
研究者
Dr Daphne Cheung
Associate Professor
The Hong Kong Polytechnic University