Optimal Timing of Computerized Cognitive Training for Older Intensive Care Unit Survivors
OPTIMIZE
2 other identifiers
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedFebruary 4, 2026
February 1, 2026
2.2 years
April 21, 2022
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Feasibility of morning-only sessions of computerized cognitive training
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 / \[30 minutes x number of intervention days\]).
7 days
Feasibility of afternoon/evening-only sessions of computerized cognitive training
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 / \[30 minutes x number of intervention days\]).
7 days
Acceptability of morning-only sessions of computerized cognitive training
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.
7 days
Acceptability of afternoon/evening-only sessions of computerized cognitive training
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.
7 days
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (3)
COG-AM
EXPERIMENTAL30-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
COG-PM
EXPERIMENTAL30-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
UC
NO INTERVENTIONStandard post-ICU inpatient care/usual care, which includes physical/occupational therapy as ordered by treatment team
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Harborview Medical Center
Seattle, Washington, 98104, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maya N Elias, PhD, MA, RN
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Study personnel evaluating cognitive function outcomes will use standardized cognitive measures and will be blinded to participants' group assignments.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Biobehavioral Nursing and Health Informatics
Study Record Dates
First Submitted
April 21, 2022
First Posted
July 20, 2022
Study Start
November 15, 2023
Primary Completion
February 2, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 4, 2026
Record last verified: 2026-02