Clinical trial NCT05467410: Optimal Timing of Computerized Cognitive Training for Older Intensive Care Unit Survivors
Official title: Optimal Timing of Computerized Cognitive Training for Older Intensive Care Unit Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Cognitive Impairment
Circadian Dysrhythmia
Intensive Care Unit Delirium
Aging
Older People
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: American Association of Critical Care Nurses
First posted: 2022-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, experimental design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of morning-only sessions of computerized cognitive training
timeFrame: 7 days
measure: Feasibility of afternoon/evening-only sessions of computerized cognitive training
timeFrame: 7 days
measure: Acceptability of morning-only sessions of computerized cognitive training
timeFrame: 7 days
measure: Acceptability of afternoon/evening-only sessions of computerized cognitive training
timeFrame: 7 days
Secondary outcomes:
measure: Cognitive function: global cognition
timeFrame: 7 days
measure: Cognitive function: verbal working memory
timeFrame: 7 days
measure: Cognitive function: executive function
timeFrame: 7 days
measure: Cognitive function: set-shifting
timeFrame: 7 days
measure: Circadian rhythm of continuous body temperature
timeFrame: 7 days
measure: Activity counts per minute
timeFrame: 7 days
measure: Total sleep time in minutes
timeFrame: 7 days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Maya N Elias, PhD, MA, RN
role: PRINCIPAL_INVESTIGATOR
References: