Developing Immersive Gamification Technology Systems for the Management of Patients With Alzheimer's Disease With Behavioral and Psychological Symptoms of Dementia (Phase 2 Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of behavioral and psychological symptoms of dementia will be assessed using the Neuropsychiatric Inventory-12
研究概览
简要总结
The proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the second phase. The phase 2 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its clinical effectiveness, safety, usability, and acceptability among patients with mild to moderate Alzheimer's disease.
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)
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
- •Aged 60 years old or older
- •Diagnosed with mild to moderate Alzheimer's dementia according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- •Montreal Cognitive Assessment-Philippines (MOCA-P) score of 10-20 inclusive
- •Neuropsychiatric Inventory (NPI-12) score 1-50 inclusive
- •Reisberg Scale Stage 4-5 inclusive
- •Stable dose of antidepressants for the past 6 weeks
- •Stable dose of antipsychotics for the past 4 weeks
- •Able to walk unassisted or with minimal assistance, with or without assistive device
- •No other explanation for condition based on reasonable clinical diagnostics
排除标准
- •Have mild cognitive impairment (no dementia)
- •Have MOCA-P score less than 10 or more than 20
- •Other non-amnestic dementia syndromes
- •Have receptive aphasia
- •Have significant visual or hearing impairment
- •Have an active psychiatric disorder prior to Alzheimer dementia diagnosis
- •Had previous episodes of seizures, diagnosis of epilepsy, or intake of antiepileptic or seizure medications
- •Have quadriplegia or paralysis of the dominant hand
- •Have a history of motion sickness
- •Experience claustrophobia
- •Have a diagnosis of a terminal illness or a life expectancy of less than one year
结局指标
主要结局
Incidence of behavioral and psychological symptoms of dementia will be assessed using the Neuropsychiatric Inventory-12
时间窗: Within one hour after completion of the fourth session
The NPI evaluates the degree and severity of BPSDs and the distress it causes the primary caregiver. Scores range from 0 to 120 where higher scores indicate greater psychiatric disturbance.
Incidence of virtual reality sickness symptoms will be assessed using the Virtual Reality Sickness Questionnaire
时间窗: Immediately after each intervention, within an hour of completion of the virtual reality game
The VRSQ will measure a participant's experience with the following symptoms: general discomfort, fatigue, eye strain, difficulty focusing, headache, fullness of head, blurring of vision, dizziness (when eyes are closed), and vertigo. Symptoms will be rated on a 4-point scale: 0 or None, 1 or Slight, 2 or Moderate, and 3 or Severe.
Usability of the virtual reality intervention will be assessed using the System Usability Scale
时间窗: Immediately after each intervention, within an hour of completion of the virtual reality game
The SUS is a 10-item questionnaire that is widely used in the evaluation of various kinds and aspects of technology. Each question has five response options ranging from 'Strongly agree' to 'Strongly disagree', which has a corresponding number value. Each response is added and multiplied by 2.5 to obtain the final score that ranges from 0 to 100. A SUS score above 68 is considered above average.
次要结局
- Cognitive function will be assessed using MOCA-P(Within one hour after completion of the fourth session)
- Cognitive function will be assessed using ADAS-Cog(Within one hour after completion of the fourth session)
- Cognitive function will be assessed using MMSE(Within one hour after completion of the fourth session)
- Activities of daily living will be assessed using ADCS-ADL(Within one hour after completion of the fourth session)
- Health-related quality of life will be assessed using DEMQOL(Within one hour after completion of the fourth session)