Early Cognitive Training and Rehabilitation to Improve Long-term Cognitive Outcomes in Older Hospitalized Adults With Delirium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 4
- 主要终点
- Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
研究概览
简要总结
This is a randomized control trial to determine if early cognitive training and rehabilitation improve 4-month cognition in hospitalized older (>=65 years old) delirious patients with and without Alzheimer's disease and related dementias. Enrolled patients will be randomized to receive cognitive intervention versus usual care at a 1:2 allocation ratio. Patients assigned to the cognitive intervention group will receive cognitive training daily during hospitalization and cognitive rehabilitation weekly for 12 weeks after hospital discharge. Patients will be evaluated for global cognition (primary outcome) and secondary outcomes at 4-months.
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
- •65 years or older
- •Admitted through the ED
- •Cognitive training can be initiated within 24 hours of ED presentation
- •Delirious at enrollment
排除标准
- •Not able to follow simple commands or non-verbal prior to the acute illness (end-stage pre-illness ADRD)
- •Resides in a nursing home
- •Receiving hospice care
- •Lives > 100 miles away from the enrolling sites
- •Non-English speaking
- •Previously enrolled
- •Deaf or blind
- •Intravenous drug, crack or cocaine, or methamphetamine use within the past one year, or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial.
- •Psychotic disorder or suicidal gesture requiring hospitalization with the past one year
- •Discharged from the ED
结局指标
主要结局
Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
时间窗: 4-months
A neuropsychological battery for global cognition which evaluates immediate and delayed memory, attention, visuospatial construction, and language. Scores range from 40 to 160, with higher scores indicating better cognition.
次要结局
- Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales(4-months)
- Functional Status as Measured by Older American Resources and Services Activities of Daily Living Scale(4-months)
- Quality of Life as Measured by the EQ-5D-5L(4-months)
- Vital Status (Dead / Alive)(4-months)
- Nursing Home Placement (Yes / no)(4-months)
- Change in Montreal Cognitive Assessment(4-months)
研究者
Jin H. Han
Associate Professor
Vanderbilt University Medical Center