A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit… (NCT06411561) | Clinical Trial Compass
RecruitingNot Applicable
A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
United States100 participantsStarted 2024-12-26
Plain-language summary
Up to 25% of intensive care unit (ICU) survivors experience cognitive impairment comparable in severity to mild Alzheimer's disease and related dementias after hospital discharge. Older ICU survivors (ages 60 and older) are at highest risk for delirium and subsequent cognitive impairment, which contribute to higher risk for cognitive decline related to Alzheimer's disease and related dementias. Sleep and activity are essential for recovery from critical illness, yet ICU survivors experience both sleep deficiency and profound inactivity. About 75-80% of ICU patients experience circadian dysrhythmia, which contributes to cognitive decline and increases likelihood of developing Alzheimer's disease and related dementias. The scientific premises of the proposed study are: 1) a combined sleep promotion and cognitive training intervention will have synergistic effects to mitigate the risk of cognitive impairment and development of Alzheimer's disease and related dementias in older ICU survivors; and 2) chronotherapeutic timing of interventions (i.e., adjusting timing of interventions according to circadian rhythm) may improve intervention efficacy.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age greater than or equal to 60 years old
* Current hospitalization at University of Washington Medical Center or Harborview Medical Center
* Intensive care unit (ICU) length of stay greater than 24 hours
* Recovery from critical care status to acute care status, and/or discharge out of ICU
* Fluent in English or Spanish
* Functional independence on activities of daily living prior to hospitalization (Katz Index = 6)
Exclusion Criteria:
* Documented history or suspicion of Alzheimer's disease or dementia, or current prescription of anti-dementia medication
* Documented history of bipolar disorder or schizophrenia
* Documented acute stroke or traumatic brain injury
* Severe vision impairment
* Severe hearing impairment
* Severe paralysis or dominant arm paresis
* Transfer from skilled nursing care facility or inpatient rehabilitation facility
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognitive function
Timeframe: Post-intervention/within 7 days of hospital discharge
2
Cognitive function
Timeframe: Follow-up at 1 month post-hospital discharge
3
Cognitive function
Timeframe: Follow-up at 6 months post-hospital discharge
4
Cognitive function
Timeframe: Follow-up at 12 months post-hospital discharge