Humanoid Robot Intervention vs Treatment as Usual For Loneliness in Long-term Care Homes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 74
- 主要终点
- Change in the University of California Los Angeles 3-item Loneliness Scale
研究概览
简要总结
The investigators are aiming to compare the effects of a humanoid robot intervention to treatment as usual, on loneliness and mental health outcomes in older adults living in long-term care, through an assessor-blinded randomized controlled trial.
详细描述
Seventy-four (n=74) older adults experiencing loneliness in 3 long-term care homes will be randomized 1:1 to an 8-week, twice a week social intervention with the Grace humanoid robot vs. a treatment as usual active control. The investigators will assess change (baseline to week 8) in (1) loneliness (primary outcome), (2) depression severity and (3) stress (secondary outcomes), as well as (4) other exploratory outcomes : anxiety, quality of life and reduction in acute healthcare utilization. The investigators will also assess the feasibility and acceptability of the intervention using qualitative methods.
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •living in a LTC home setting in Montreal
- •cognitively healthy, mild cognitive impairment (MCI) or mild dementia (MMSE score of >20/clinical opinion of LTC homes staff members)
- •able to provide consent
- •loneliness UCLA-3 score of ≥ 6 or more (moderate-severe loneliness).
排除标准
- •do not speak English
- •inability to provide consent
- •moderate to severe dementia (MMSE score <18/diagnosis of moderate-severe dementia/clinical opinion of LTC homes staff members)
- •significant hearing loss
- •acutely unstable medical illnesses, including delirium, acute cerebrovascular/cardiovascular events within the last 6 months; having a terminal medical diagnosis with prognosis of less than 12 months
- •high suicide risk (e.g. active suicidal ideation and/or current/recent intent or plan).
结局指标
主要结局
Change in the University of California Los Angeles 3-item Loneliness Scale
时间窗: Baseline and Week 8
Commonly-used validated scale to screen for loneliness. Higher scores on this scale mean higher levels of loneliness.
次要结局
- Change in the Perceived Stress Scale(Baseline and Week 8)
- Patient Health Questionnaire(Baseline and Week 8)
研究者
Soham Rej MD, MSc
Principal Investigator
Lady Davis Institute