Timing of Cognitive Training for ICU Survivors' Cognitive Impairment

(OPTIMIZE Trial)

Overseen By Maya N Elias, PhD, MA, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Anti-dementia medications

Disqualifiers: Alzheimer's, Dementia, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment COG-AM, COG-PM for ICU survivors' cognitive impairment?

Research suggests that early cognitive intervention training can help improve cognitive impairment in critical patients, which may support the potential effectiveness of treatments like COG-AM and COG-PM for ICU survivors. ^{1 2 3 4 5}

Is cognitive training safe for ICU survivors?

The research does not provide specific safety data for cognitive training in ICU survivors, but it suggests that cognitive rehabilitation and prevention strategies are being explored to improve outcomes for critical illness survivors. ^{1 4 6 7 8}

How does the COG-AM, COG-PM treatment differ from other treatments for cognitive impairment in ICU survivors?

The COG-AM and COG-PM treatments are unique because they focus on the timing of cognitive training for ICU survivors, which is not a standard approach for addressing cognitive impairment in this population. Unlike other treatments that may not consider the timing of interventions, this study aims to determine the optimal timing for cognitive training to improve recovery outcomes. ^{1 2 3 6 9}

Research Team

Maya N Elias, PhD, MA, RN

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for ICU survivors aged 60 or older who have stayed in the ICU for at least 24 hours, are fluent in English, and were independent before hospital admission. It's not for those with severe arm paralysis, recent stroke or brain injury, multiple ICU stays this admission, Alzheimer's/dementia history or anti-dementia meds use, bipolar disorder/schizophrenia history, or severe visual impairment.

Inclusion Criteria

You are currently staying in the University of Washington Medical Center.

I am being moved from the ICU to a regular hospital unit soon.

I am 60 years old or older.

Exclusion Criteria

I have severe weakness or paralysis in my dominant arm.

I've been in the ICU multiple times during this hospital stay.

You have very poor eyesight and are unable to use an iPad for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a computerized cognitive training intervention either in the morning or afternoon/evening, in addition to usual care

7 days

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• COG-AM
• COG-PM

Trial Overview The study tests if computerized cognitive training (COG) helps improve cognitive function when done at different times: morning (COG-AM) vs. late afternoon/evening (COG-PM), compared to standard care. It also looks into how these sessions affect circadian rhythms and whether daytime activity influences the outcomes.

Participant Groups

Group I: COG-PM Experimental Treatment 1 Intervention

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 II: COG-AM Experimental Treatment 1 Intervention

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 III: UC Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

American Association of Critical-Care Nurses

Collaborator

Trials

3

Recruited

180+

American Association of Critical Care Nurses

Collaborator

Trials

4

Recruited

180+

References

1. United States pubmed.ncbi.nlm.nih.gov

Natural History of Cognitive Impairment in Critical Illness Survivors. A Systematic Review. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive sequelae in acute respiratory distress syndrome patients with and without recall of the intensive care unit. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a web-based neurocognitive battery for assessing cognitive function in critical illness survivors. [2020]

4. China pubmed.ncbi.nlm.nih.gov

[Effects of early intervention training on cognitive impairment in critical patients]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Development and Validation of an Abbreviated Questionnaire to Easily Measure Cognitive Failure in ICU Survivors: A Multicenter Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term Cognitive and Functional Impairments After Critical Illness. [2019]

7. China pubmed.ncbi.nlm.nih.gov

[Analysis of the risk factors of cognitive impairment in post-intensive care syndrome patient]. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Cognitive impairment after intensive care unit discharge: a Meta-analysis]. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Short- and long-term cognitive outcomes in intensive care unit survivors. [2022]