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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Cognitive Impairment; Aging; Circadian Dysrhythmia; Intensive Care Unit Delirium
• Intervention / Treatment: Behavioral: COG-AM; Behavioral: COG-PM

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya N Elias, PhD, MA, RN; Phone Number: 206-543-8564; Email: mnelias@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington Medical Center
      • Contact: Maya N Elias, PhD, MA, RN; Phone Number: 206-543-9564; Email: mnelias@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COG-AM; 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	Behavioral: 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.
Experimental: COG-PM; 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	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.
No Intervention: UC; Standard post-ICU inpatient care/usual care, which includes physical/occupational therapy as ordered by treatment team

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of morning-only sessions of computerized cognitive training	A retention rate of 80% will determine feasibility: the percentage of participants who complete all COG-AM sessions and 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 80% will determine feasibility: the percentage of participants who complete all COG-PM sessions and 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function: attention	NIH Toolbox Cognition Battery: Flanker Inhibitory Control and Attention Test (age- and education-adjusted T-score); range: 0-100; higher scores indicate better performance	7 days
Cognitive function: cognitive flexibility	NIH Toolbox Cognition Battery: Dimensional Change Card Sort Test (age- and education-adjusted T-score); range: 0-100; higher scores indicate better performance	7 days
Cognitive function: processing speed	NIH Toolbox Cognition Battery: Pattern Comparison Processing Speed Test (age- and education-adjusted T-score); range: 0-100; higher scores indicate better performance	7 days
Cognitive function: global cognition	National Alzheimer's Coordinating Center Uniform Data Set: Montreal Cognitive Assessment; range: 0-30; higher scores indicate better performance	7 days
Cognitive function: verbal working memory	National Alzheimer's Coordinating Center Uniform Data Set: Number Span Test Forward; number of correct trials, range: 0-14; higher scores indicate better performance	7 days
Cognitive function: executive function	National Alzheimer's Coordinating Center Uniform Data Set: Number Span Test Backward; number of correct trials, range: 0-14; higher scores indicate better performance	7 days
Cognitive function: set-shifting	National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance	7 days
Circadian rhythm of continuous body temperature	Circadian rhythm: amplitude, acrophase, mesor via continuous body temperature obtained from wearable sensors	7 days
Activity counts per minute	Daytime activity: activity counts per minute during daytime hours via wrist actigraphy	7 days
Total sleep time in minutes	Nighttime sleep: total sleep time in minutes during nighttime hours via wrist actigraphy	7 days

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: American Association of Critical Care Nurses
• Investigators: Principal Investigator: Maya N Elias, PhD, MA, RN, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: STUDY00014922; 40067 (Other Grant/Funding Number: American Association of Critical-Care Nurses (AACN))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No