Impact of a Novel Socially Assistive Robotic Architecture on Engaging Older Adults With Mild Cognitive Impairment, Alzheimer's Disease and Related Dementia in Long Term Care Settings
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Change in Apathy
研究概览
简要总结
The objective of this study is to demonstrate the impact of a socially assistive robot system on reducing apathy among cognitively impaired older adults residing in long term care facilities. Earlier phases of this project demonstrated the feasibility and acceptability of the robotic system. First, investigators will improve the social robotic interaction architecture through additional software development, enhance its versatility, and make it easy for non-experts to run. Second, 188 participants will be randomized to either usual activity programs at the long term care facility, or the usual activity programs plus the robotic activities. Researchers will examine the effect on apathy and also plan on examining underlying individual and facility factors that influence the impact of the robotic activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Trained research assistants separate from other research personnel will collect outcomes; these research personnel will be blinded to the hypotheses and group assignments.
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
- •Residing >3 months in long term care facility
- •Evidence of mild cognitive impairment (SAGE score 15-16), mild dementia (SAGE score <15, AD8<2, DSRD<19), or moderate dementia (SAGE <15, AD8>1, DSRD 19-36)
- •Symptoms of apathy (Score 30+ on AES-C)
排除标准
- •Severe cognitive impairment
- •Physically unable to participate
- •Unable to provide assent
- •Uncorrected vision or hearing
- •Never spoke English
- •Unable to sit comfortably in chair
- •Acutely ill, terminally ill or unresponsive
- •Unable to be moved to activity location
- •Aggressive or combative
研究组 & 干预措施
Socially Assistive Robot Activity
Participants will attend two sessions per week and interact with the robot. Four weeks with a humanoid robot and four weeks with a dog robot. Participants can continue to join other activities held within the facility.
干预措施: Socially Assistive Robot Activity (Behavioral)
Usual Activity Program
Participants will attend at least two sessions per week at activities held within the facility. They will not be exposed to the robot activities.
干预措施: Socially Assistive Robot Activity (Behavioral)
结局指标
主要结局
Change in Apathy
时间窗: Baseline to Week 8
Apathy Evaluation Scale - Clinician (AES-C) will be used to assess changes in composite apathy score from baseline, Week 4, and Week 8. The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate greater apathy.
次要结局
- Change in Animal Fluency Test(Baseline to Week 8)
- Change in Trail Making Test (TMT)(Baseline to Week 8)
研究者
Nilanjan Sarkar
David K. Wilson Professor of Engineering
Vanderbilt University