Effects of an Algorithmically Enhanced Personalized Music-based Intervention in Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Memory
研究概览
简要总结
This 6 - 12 week longitudinal study will include patients with Dementia.
Participants will be randomized into one of two groups: a) an intervention group, in which patients will listen to music using Rubato Life app, and b) a control group, in which patients will receive standard of care.
Patients in intervention group will be asked to listen to at least 30 minutes per day, (or a total of 3.5 hours per week) for a period of 6 -12 weeks, coming up to their scheduled follow up appointment. Patients in the Intervention group will wear smartwatches to monitor heart rate variability throughout the study.
详细描述
A. Specific Aims/Objectives:
- Primary Aim: Determine if Rubato Life (RL) music selection is effective making improvements in the emotional, functional and cognitive dimensions of patients with Dementia.
o H1: The investigators hypothesize that using personalized musical playlists, through RL, will improve emotional, functional and cognitive outcomes for patients with Dementia.
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Secondary Aim: Determine the incremental improvements in the emotional, functional and cognitive dimensions from RL's music selection over standard of care.
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H2: The investigators hypothesize that the magnitude of emotional, functional and cognitive improvements will be significantly higher for patients using RL than for patients only with the standard of care.
B. Background and Significance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Aged 18 or older
- •Diagnosed with Dementia, requiring reassessment every 3 month
- •Have access to a smartphone and able to operate smartphone (or their caretaker)
- •Have a Google or Apple ID. (or their caretaker)
排除标准
- •Participants with hearing disorders who do not use hearing aids
- •Participants who have extreme dislike of music.
- •Participants who cannot comply with the minimum time Rubato Life application requires to be used. (or their caretaker)
结局指标
主要结局
Memory
时间窗: 12 weeks
Will be assessed using the Immediate Prose Memory Test (IPMT)
Anxiety
时间窗: 12 weeks
Will be assessed using the State-Trait Anxiety Inventory- State (STAI-S)
Depression
时间窗: 12 weeks
Will be assessed using the Geriatric Depression Scale (GDS)
Cognition
时间窗: 12 weeks
Will be assessed using the Mini examination of the mental state (Mini)
次要结局
未报告次要终点