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Behavioural Intervention

Timing of Cognitive Training for ICU Survivors' Cognitive Impairment (OPTIMIZE Trial)

N/A

Recruiting

Led By Maya Elias

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Active transfer order or expected discharge from ICU to a post-ICU unit

Age ≥ 60 years

Must not have

Severe dominant arm paresis/paralysis (actigraphy measurement)

Multiple ICU stays throughout present hospital admission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine the optimal timing of cognitive interventions to improve cognitive function in older adults in ICU. It will compare a morning vs. late afternoon/evening session to standard care.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since COG involves non-invasive computer activities there may be minimal side effects such as eye strain from screen time or potential frustration with tasks; however specific side effects will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 60 years old or older.

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I do not have Alzheimer's disease or dementia.

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I have stayed in the ICU for at least 24 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe weakness or paralysis in my dominant arm.

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

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I was transferred from another hospital, rehab, or care facility.

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I have been diagnosed or suspected to have Alzheimer's/dementia, or I am on medication for it.

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I have a documented history of bipolar disorder or schizophrenia.

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I have had a recent stroke or brain injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of afternoon/evening-only sessions of computerized cognitive training

Acceptability of morning-only sessions of computerized cognitive training

Feasibility of afternoon/evening-only sessions of computerized cognitive training

+1 more

Secondary study objectives

Activity counts per minute

Circadian rhythm of continuous body temperature

Cognitive function: attention

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: COG-PMExperimental Treatment1 Intervention

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

Group II: COG-AMExperimental Treatment1 Intervention

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

Group III: UCActive Control1 Intervention

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

0 / 10Eligibility criteria met