Benefit of Virtual Reality Headset Use on Apathy in Older Adults With Major Neurocognitive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- RIVAGES
- 入组人数
- 30
- 试验地点
- 12
- 主要终点
- Tolerance of virtual reality sessions
研究概览
简要总结
The goal of this clinical trial is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders. The main questions it aims to answer are:
- Does virtual reality have an impact on symptoms of apathy in the elderly?
- Is virtual reality well tolerated by the elderly? Participants will benefit from a 3-session virtual reality headset program with a healthcare professional. They will have one session per week for 3 weeks. They will be observed by another professional, who will complete observation grids on apathy, engagement in activity and tolerance of the virtual reality headset.
There is not a comparison group: Researchers will compare the scores before and after the intervention: the participant will be his own control.
详细描述
This study is a multicenter interventional exploratory study in two nursing homes and a geriatric long-term care service. Thirty patients will be included. They will be recruited from residents of the long-term care departments of two hospitals, and 4 nursing homes.
A pre- and post-intervention comparison will be made by assessing apathy using the apathy inventory and the neuropsychiatric inventory in the care team version. A comparison of participants' engagement will be carried out through ecological observation of the interventions. This will be objectivized by the Caregiver Interaction Behavior Scale (ECPAI) before the immersion program, and during the first and third virtual reality sessions. An ECPAI scale taken during a conventional animation prior to the program will establish a baseline state for the participant.
The main goal is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 110 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons over 65 years of age
- •Persons living in nursing homes or hospitalized in long-term care
- •Persons with correct vision or vision corrected by glasses
- •People with no hearing problems, or with hearing loss corrected by a hearing aid
- •Person with a major neurocognitive disorder
- •Person with a Mini Mental State Examination (MMSE) cognitive score <26
- •Individuals with documented apathy
排除标准
- •Person with a history of epilepsy
- •Persons wearing a pacemaker
- •Person with open wounds of the face or skull
- •Disabling headache or neck pain
- •Person at the immediate end of life or in active palliative care
- •Person with a contagious disease
- •People who are bedridden or unable to get into a wheelchair
- •Persons with severe neurological impairment
- •Person with severe behavioral disorders endangering self or staff
- •Persons unable to give oral consent
结局指标
主要结局
Tolerance of virtual reality sessions
时间窗: through study completion, an average of 6 months
No change in Simulator Sickness Questionnaire (SSQ), or maintenance of "none" and "slight" scores. There are 16 items, each item is rated with the scale from none, slight, moderate to severe. After some calculations you have 3 subscores : Computation of nausea (N), oculomotor r disturbance (O), disorientation (D), and total simulator sickness (TS) scores.
Effectiveness of virtual reality sessions on apathy symptoms
时间窗: through study completion, an average of 6 months
Decrease in apathy scores on the Apathy Inventory (IA) (NPI). IA clinician assessment (0 to 4 score) has to take into account several factors: useful observation points, Patient history and social environment, personality, Information coming from the caregiver, Patient's responses to the clinical domains, autonomy. A score equal or upper to 4 is pathological.
次要结局
- Security(through study completion, an average of 6 months)