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

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University of Washington

Status

Enrolling

Conditions

Circadian Dysrhythmia
Aging
Cognitive Impairment
Critical Illness
Intensive Care Unit Delirium

Treatments

Behavioral: COG-AM
Behavioral: COG-PM

Study type

Interventional

Funder types

Other

Identifiers

NCT05467410
STUDY00014922
40067 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 3 patient groups

COG-AM
Experimental group
Description:
30-minute morning session of a computerized cognitive training intervention (Lumosity), delivered between the hours of 09:00 AM - 12:00 PM, in addition to UC
Treatment:
Behavioral: COG-AM
COG-PM
Experimental group
Description:
30-minute afternoon/evening session of a computerized cognitive training intervention (Lumosity), delivered between the hours of 15:00 PM - 18:00 PM, in addition to UC
Treatment:
Behavioral: COG-PM
UC
No Intervention group
Description:
Standard post-ICU inpatient care/usual care, which includes physical/occupational therapy as ordered by treatment team

Trial contacts and locations

1

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Central trial contact

Maya N Elias, PhD, MA, RN

Data sourced from clinicaltrials.gov

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