Reserve For Delirium Superimposed On Dementia (DSD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 18
- 主要终点
- Confusion Assessment Method
研究概览
简要总结
The purpose of this study is to test the effectiveness of cognitively stimulating activities for resolving delirium in people with dementia.
详细描述
The primary aim in this RCT is to test the efficacy of Recreational Stimulation for Elders as a Vehicle to resolve DSD (RESERVE- DSD). The investigators will randomize 256 subjects, newly admitted to post acute care, to intervention (RESERVE-DSD) or control (usual care). Intervention subjects will receive 30-minute sessions of tailored cognitively stimulating recreational activities for up to 30 days. The investigators hypothesize that subjects who receive RESERVE-DSD will have: decreased severity and duration of delirium; greater gains in attention, orientation, memory, abstract thinking, and executive functioning; and greater gains in physical function compared to subjects with DSD who receive usual care. The investigators will also evaluate potential moderators of intervention efficacy (lifetime of complex mental activities and APOE status). The secondary aim is to describe the costs associated with RESERVE-DSD.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of delirium
- •mild to moderate cognitive impairments
- •65 years of age or older
- •English speaking
- •community-dwelling
- •legally authorized representative available
排除标准
- •severe vision or hearing problems
- •diagnosis of
- •major depression
- •Parkinson's with Lewy Body disease
- •Huntington's disease
- •normal pressure hydrocephalus
- •seizure disorder
- •subdural hematoma
- •head trauma
- •known structural brain abnormalities
- •acute CVA/stroke
- •acute psychiatric condition
- •life expectancy < 6 months
结局指标
主要结局
Confusion Assessment Method
时间窗: Averaged over 30 days or until discharge, whichever comes first
Delirium Rating Scale
时间窗: Averaged over 30 days or until discharge, whichever comes first
次要结局
- Executive Function(Averaged over 30 days or until discharge, whichever comes first)
- Physical Function(Averaged over 30 days or until discharge, whichever comes first)
- Memory(Averaged over 30 days or until discharge, whichever comes first)
- Abstract Thinking(Averaged over 30 days or until discharge, whichever comes first)
- Attention(Averaged over 30 days or until discharge, whichever comes first)
- Orientation(Averaged over 30 days or until discharge, whichever comes first)
研究者
Ann Kolanowski
Professor of Nursing
Penn State University