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临床试验/NCT05467410
NCT05467410进行中(未招募)不适用

Optimal Timing of Computerized Cognitive Training for Older Intensive Care Unit Survivors

University of Washington3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年11月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
3
主要终点
Acceptability of morning-only sessions of computerized cognitive training

研究概览

简要总结

More than 60% of intensive care unit (ICU) patients are adults ages 60 and older, who are at high risk for ICU-acquired cognitive impairment. After ICU discharge, ICU survivors often experience sleep disturbances and inactivity, and almost 80% of ICU patients experience disturbances in circadian rhythm, which may affect cognitive function. Understanding the optimal, chronotherapeutic timing of cognitive interventions is crucial to promote circadian realignment and cognitive function, and may improve intervention feasibility, acceptability, and efficacy. Specific Aim 1 will determine feasibility, acceptability, and preliminary effect sizes for: 1) a morning session of a computerized cognitive training intervention [COG]; and 2) a late afternoon/early evening session of the COG intervention; compared to 3) standard inpatient care/usual care [UC]. Specific Aim 2 will examine circadian rhythm parameters to determine the optimal timing of the daily COG intervention. Exploratory Aim 3 will explore if the effects of the COG intervention on cognitive function are mediated by daytime activity, and explore if selected biological and clinical factors moderate intervention effects on cognitive function.

详细描述

Over 60% of intensive care unit (ICU) patients are older adults (ages 60 and older). Up to 40% of ICU survivors experience cognitive impairment that is comparable in severity to moderate traumatic brain injury, while 25% have symptoms similar to mild Alzheimer's disease after hospital discharge. Older ICU survivors are at high risk for ICU-acquired cognitive impairment, often leading to a protracted recovery in a care facility. Several factors, including circadian misalignment (observed in about 75-80% of ICU patients), may decrease effects of interventions designed to improve cognitive function. Further, daytime activity is essential for recovery from critical illness and to promote circadian realignment, yet ICU survivors experience profound inactivity. The scientific premise of the proposed research is that identifying the optimal circadian timing of cognitive interventions for older ICU survivors may improve intervention feasibility, acceptability, and efficacy. Interventions targeting symptoms (i.e., disturbances in circadian rhythm and cognitive impairment) may deliver similar outcomes across conditions that require ICU admission (e.g., cancer, heart failure, pneumonia, hip fracture). To date, interventions have not been evaluated in older ICU survivors that simultaneously target circadian misalignment and cognitive impairment. Moreover, because circadian misalignment adversely affects cognitive function, understanding the optimal timing of cognitive interventions is crucial to promote both circadian realignment and cognitive function. Specific Aim 1 will determine feasibility, acceptability, and preliminary effect sizes for: 1) a morning session of a computerized cognitive training intervention [COG]; and 2) a late afternoon/early evening session of the COG intervention; compared to 3) standard inpatient care/usual care [UC]. Specific Aim 2 will examine circadian rhythm parameters to determine the optimal timing of the daily COG intervention. Exploratory Aim 3 will explore if the effects of the COG intervention on cognitive function are mediated by daytime activity, and explore if selected biological and clinical factors moderate intervention effects on cognitive function. The proposed early-stage clinical trial will be the first to evaluate chronotherapeutic timing of a computerized cognitive training intervention for hospitalized older ICU survivors after ICU discharge, to initiate early cognitive recovery on a post-ICU unit.

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

Study personnel evaluating cognitive function outcomes will use standardized cognitive measures and will be blinded to participants' 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

入选标准

  • Age ≥ 60 years
  • ICU length of stay ≥ 24 hours
  • Active transfer order or expected discharge from ICU to a post-ICU unit
  • Fluent in English
  • Functional independence prior to hospital admission (Katz Index = 6)
  • No suspicion of Alzheimer's disease/dementia
  • Current hospitalization at University of Washington Medical Center or Harborview Medical Center

排除标准

  • Documented history or suspicion of Alzheimer's disease/dementia, or current prescription of anti-dementia medication
  • Documented history of bipolar disorder or schizophrenia
  • Documented acute stroke or acute traumatic brain injury
  • Severe visual impairment
  • Severe hearing impairment
  • Severe dominant arm paresis/paralysis
  • Transfer from inpatient rehabilitation or skilled nursing care facility

研究组 & 干预措施

COG-AM

Experimental

30-minute morning session of a laptop-based computerized cognitive training intervention, delivered between the hours of 09:00 AM - 12:00 PM, in addition to UC

干预措施: COG-AM (Behavioral)

COG-PM

Experimental

30-minute afternoon/evening session of a laptop-based computerized cognitive training intervention, delivered between the hours of 15:00 PM - 18:00 PM, in addition to UC

干预措施: COG-PM (Behavioral)

UC

No Intervention

Standard post-ICU inpatient care/usual care, which includes physical/occupational therapy as ordered by treatment team

结局指标

主要结局

Acceptability of morning-only sessions of computerized cognitive training

时间窗: 7 days

Likert-type surveys including open-ended questions will be collected regarding acceptability of the COG-AM intervention. To evaluate tolerability, reasons why participants were unable to complete COG-AM sessions in their entirety will be recorded.

Acceptability of afternoon/evening-only sessions of computerized cognitive training

时间窗: 7 days

Likert-type surveys including open-ended questions will be collected regarding acceptability of the COG-PM intervention. To evaluate tolerability, reasons why participants were unable to complete COG-PM sessions in their entirety will be recorded.

Feasibility of morning-only sessions of computerized cognitive training

时间窗: 7 days

A retention rate of \>70% will determine feasibility: the percentage of participants who complete at least 60 minutes of COG-AM sessions and all cognitive outcome assessments. Adherence to the COG-AM intervention will be defined as the proportion of minutes spent training by the total minutes required per protocol (total minutes trained / \[30 minutes x number of intervention days\]).

Feasibility of afternoon/evening-only sessions of computerized cognitive training

时间窗: 7 days

A retention rate of \>70% will determine feasibility: the percentage of participants who complete at least 60 minutes of COG-PM sessions and all cognitive outcome assessments. Adherence to the COG-PM intervention will be defined as the proportion of minutes spent training by the total minutes required per protocol (total minutes trained / \[30 minutes x number of intervention days\]).

次要结局

  • Cognitive function: global cognition(7 days)
  • Cognitive function: verbal working memory(7 days)
  • Cognitive function: executive function(7 days)
  • Cognitive function: set-shifting(7 days)
  • Circadian rhythm of continuous body temperature(7 days)
  • Activity counts per minute(7 days)
  • Total sleep time in minutes(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maya Elias, PhD, RN

Assistant Professor, Department of Biobehavioral Nursing and Health Informatics

University of Washington

研究点 (3)

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