A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cognitive function
研究概览
简要总结
Up to 25% of intensive care unit (ICU) survivors experience cognitive impairment comparable in severity to mild Alzheimer's disease and related dementias after hospital discharge. Older ICU survivors (ages 60 and older) are at highest risk for delirium and subsequent cognitive impairment, which contribute to higher risk for cognitive decline related to Alzheimer's disease and related dementias. Sleep and activity are essential for recovery from critical illness, yet ICU survivors experience both sleep deficiency and profound inactivity. About 75-80% of ICU patients experience circadian dysrhythmia, which contributes to cognitive decline and increases likelihood of developing Alzheimer's disease and related dementias. The scientific premises of the proposed study are: 1) a combined sleep promotion and cognitive training intervention will have synergistic effects to mitigate the risk of cognitive impairment and development of Alzheimer's disease and related dementias in older ICU survivors; and 2) chronotherapeutic timing of interventions (i.e., adjusting timing of interventions according to circadian rhythm) may improve intervention efficacy.
详细描述
Using a 2 x 2 factorial design, 100 English- or Spanish-speaking older ICU survivors will be enrolled after discharge out of ICU and randomized to one of 4 combinations of two interventions: SLEEP and COG. We propose that the combination of a nighttime sleep promotion intervention [SLEEP: nighttime use of earplugs and eye masks] and a daytime computerized cognitive training intervention [COG: daily 30-minute cognitive training sessions] may produce synergistic effects on cognitive function to mitigate delirium and reduce risk of incident Alzheimer's disease and related dementias. Because circadian dysrhythmia contributes to cognitive decline, chronotherapeutic timing of the COG intervention could maximize intervention efficacy.
Specific Aim 1: Test the separate and combined effects of SLEEP and COG [SLEEP + COG, SLEEP, COG] versus an active control [AC] in improving cognitive function for older ICU survivors.
Specific Aim 2: Examine circadian rhythm parameters of continuous body temperature (iButton: wearable sensor) to determine the optimal window for timing of the COG intervention.
Specific Aim 3: Examine if the effects of each intervention on cognitive function are mediated by sleep and activity, and examine if selected biological and clinical factors moderate intervention effects.
Exploratory Aim 4: Explore the effect of each intervention on cognitive function at 1 month and incident Alzheimer's disease and related dementias at 6 months and 12 months post-hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- 否
入选标准
- •Age greater than or equal to 60 years old
- •Current hospitalization at University of Washington Medical Center or Harborview Medical Center
- •Intensive care unit (ICU) length of stay greater than 24 hours
- •Recovery from critical care status to acute care status, and/or discharge out of ICU
- •Fluent in English or Spanish
- •Functional independence on activities of daily living prior to hospitalization (Katz Index = 6)
排除标准
- •Documented history or suspicion of Alzheimer's disease or dementia, or current prescription of anti-dementia medication
- •Documented history of bipolar disorder or schizophrenia
- •Documented acute stroke or traumatic brain injury
- •Severe vision impairment
- •Severe hearing impairment
- •Severe paralysis or dominant arm paresis
- •Transfer from skilled nursing care facility or inpatient rehabilitation facility
研究组 & 干预措施
SLEEP + COG
- Combination of SLEEP and COG interventions, for up to 7 days/nights + usual post-ICU inpatient care
- Personalized timing of morning, afternoon, or evening COG sessions, based on CSM scale at baseline
干预措施: SLEEP + COG (Behavioral)
COG
- Daily 30-minute computerized cognitive training sessions (Lumosity), for up to 7 days + usual post-ICU inpatient care
- Personalized timing of morning, afternoon, or evening COG intervention sessions, based on CSM scale at baseline
干预措施: COG (Behavioral)
SLEEP
- Nighttime use of earplugs and eye masks, for up to 7 nights + usual post-ICU inpatient care
干预措施: SLEEP (Behavioral)
AC
- Active comparator condition; delivery of educational modules on brain health + usual post-ICU inpatient care
干预措施: AC (Behavioral)
结局指标
主要结局
Cognitive function
时间窗: Follow-up at 12 months post-hospital discharge
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Cognitive function
时间窗: Post-intervention/within 7 days of hospital discharge
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Cognitive function
时间窗: Follow-up at 1 month post-hospital discharge
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Cognitive function
时间窗: Follow-up at 6 months post-hospital discharge
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
次要结局
- Cognitive function: executive function, working memory(Follow-up at 12 months post-hospital discharge)
- Cognitive function: executive function, set-shifting(Follow-up at 12 months post-hospital discharge)
- Cognitive function: executive function, working memory(Post-intervention/within 7 days of hospital discharge)
- Cognitive function: executive function, working memory(Follow-up at 1 month post-hospital discharge)
- Cognitive function: executive function, working memory(Follow-up at 6 months post-hospital discharge)
- Cognitive function: executive function, set-shifting(Post-intervention/within 7 days of hospital discharge)
- Cognitive function: executive function, set-shifting(Follow-up at 1 month post-hospital discharge)
- Cognitive function: executive function, set-shifting(Follow-up at 6 months post-hospital discharge)
研究者
Maya Elias, PhD, RN
Assistant Professor, School of Nursing
University of Washington