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

Aging Clinical Trial

— OPTIMIZE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05467410
• Other study ID #: STUDY00014922
• Secondary ID: 40067
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Washington
• Contact: Maya N Elias, PhD, MA, RN
• Phone: 206-543-8564
• Email: mnelias[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Circadian Dysrhythmia
• Cognitive Impairment
• Critical Illness
• Intensive Care Unit Delirium

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	American Association of Critical Care Nurses

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Circadian rhythm of continuous body temperature	Circadian rhythm: amplitude, acrophase, mesor via continuous body temperature obtained from wearable sensors	7 days
Secondary	Activity counts per minute	Daytime activity: activity counts per minute during daytime hours via wrist actigraphy	7 days
Secondary	Total sleep time in minutes	Nighttime sleep: total sleep time in minutes during nighttime hours via wrist actigraphy	7 days