40 Participants Needed

Timing of Cognitive Training for ICU Survivors' Cognitive Impairment

(OPTIMIZE Trial)

ME
MN
Overseen ByMaya N Elias, PhD, MA, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal time of day for cognitive training exercises in individuals recently in the ICU. It seeks to determine whether morning (COG-AM) or afternoon (COG-PM) exercises better enhance brain function and daily rhythms. Participants will engage in morning or afternoon brain training on a laptop or continue with usual care. This trial is suitable for adults aged 60 and older who have recently spent at least 24 hours in an ICU and do not have dementia. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve recovery strategies for ICU patients.

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 prior data suggests that this cognitive training intervention is safe for ICU survivors?

Research has shown that cognitive training programs like COG-AM and COG-PM have not raised specific safety concerns in past studies. These treatments involve short, daily laptop sessions, which most participants find easy to manage. Although specific safety data for ICU survivors is lacking, similar cognitive training methods have been used without major issues.

These treatments are non-invasive, meaning they don't involve procedures that break the skin or enter the body, which typically reduces the risk of side effects. Since this trial is in the "Not Applicable" phase, it focuses on assessing how well participants can handle and accept the training, rather than testing for safety. This phase usually indicates that earlier research found these treatments safe enough to proceed.

In summary, while detailed safety data is not available, the nature of the treatment and the trial phase suggest it is likely safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the timing of cognitive training for ICU survivors because it explores how the timing of rehabilitation exercises can impact recovery. Unlike standard post-ICU care, which typically includes physical and occupational therapy at any time, this trial looks at whether morning (COG-AM) or afternoon (COG-PM) sessions of computer-based cognitive training can make a difference. The idea is that our brains might be more receptive to training at specific times of the day, potentially speeding up recovery and improving cognitive outcomes for ICU survivors. By tailoring the timing of these cognitive exercises, we might uncover a simple yet effective way to enhance treatment outcomes.

What evidence suggests that this trial's treatments could be effective for ICU survivors' cognitive impairment?

Research has shown that brain exercises can improve memory and thinking skills in people who have been in the ICU. Starting these exercises early can reduce memory and thinking problems, especially in very sick patients. Studies have found that about one-third of ICU survivors experience these issues. In this trial, participants will receive either the COG-AM or COG-PM treatments, which are computer-based brain exercises designed to boost brain function. Sessions occur at different times of the day to determine optimal effectiveness. The aim is to help ICU survivors enhance their memory and thinking skills.12367

Who Is on the Research Team?

MN

Maya N Elias, PhD, MA, RN

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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.
See 4 more

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.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: COG-PMExperimental Treatment1 Intervention
Group II: COG-AMExperimental Treatment1 Intervention
Group III: UCActive Control1 Intervention

Find a Clinic Near You

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+

Citations

Optimal Timing of Computerized Cognitive Training for ...A retention rate of 80% will determine feasibility: the percentage of participants who complete at least 60 minutes of COG-AM sessions and all cognitive outcome ...
Optimal Timing of Computerized Cognitive Training for ...Outcome Measures​​ A retention rate of 80% will determine feasibility: the percentage of participants who complete at least 60 minutes of COG-AM sessions and all ...
Estimated prevalence of post-intensive care cognitive ...A review of 19 studies reported a wide range of cognitive impairment in 4–62% of patients during post-ICU periods ranging from 2 to 156 months [ ...
Timing of Cognitive Training for ICU Survivors ...Research suggests that early cognitive intervention training can help improve cognitive impairment in critical patients, which may support the potential ...
Clinical identification of cognitive impairment in ICU survivorsCurrent data suggest that approximately one-third or more of ICU survivors develop ongoing and persistent cognitive impairment [6]. Among specific populations ...
Cognitive Assessment at Intensive Care Unit DischargeUp to 62% of patients discharged from an intensive care unit have significant cognitive impairment that is not associated with severity of illness.
Cognitive impairment in ICU survivors: Assessment and ...Current data suggest that neuro- cognitive impairment after an ICU stay is common and that it persists 6 years or more after hospital discharge. Hopkins et al14 ...
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