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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness Cognitive Impairment Circadian Dysrhythmia Intensive Care Unit Delirium Aging Older People

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, experimental design

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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COG-AM

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

Group Type EXPERIMENTAL

COG-AM

Intervention Type BEHAVIORAL

Participants who are randomized to the COG-AM intervention group will be asked to complete 30-minute computerized cognitive training (Lumosity cognitive training program) sessions during morning hours (between 09:00-12:00), for a total of 7 days or until hospital discharge, whichever comes first. Participants will complete cognitive training sessions in each of the following subdomains: memory, attention, problem solving, cognitive flexibility, and processing speed.

COG-PM

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

Group Type EXPERIMENTAL

COG-PM

Intervention Type BEHAVIORAL

Participants who are randomized to the COG-PM intervention group will be asked to complete 30-minute computerized cognitive training (Lumosity cognitive training program) sessions during late afternoon/early evening hours (between 15:00-18:00), for a total of 7 days or until hospital discharge, whichever comes first. Participants will complete cognitive training sessions in each of the following subdomains: memory, attention, problem solving, cognitive flexibility, and processing speed.

UC

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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COG-AM

Participants who are randomized to the COG-AM intervention group will be asked to complete 30-minute computerized cognitive training (Lumosity cognitive training program) sessions during morning hours (between 09:00-12:00), for a total of 7 days or until hospital discharge, whichever comes first. Participants will complete cognitive training sessions in each of the following subdomains: memory, attention, problem solving, cognitive flexibility, and processing speed.

Intervention Type BEHAVIORAL

COG-PM

Participants who are randomized to the COG-PM intervention group will be asked to complete 30-minute computerized cognitive training (Lumosity cognitive training program) sessions during late afternoon/early evening hours (between 15:00-18:00), for a total of 7 days or until hospital discharge, whichever comes first. Participants will complete cognitive training sessions in each of the following subdomains: memory, attention, problem solving, cognitive flexibility, and processing speed.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No