Status:

RECRUITING

A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors

Lead Sponsor:

University of Washington

Collaborating Sponsors:

National Institute on Aging (NIA)

Conditions:

Critical Illness

Delirium

Eligibility:

All Genders

60+ years

Phase:

NA

Brief 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 ...

Detailed Description

Using a 2 x 2 factorial design, 100 English- or Spanish-speaking older ICU survivors will be enrolled after discharge out of ICU and randomized to one of 4 combinations of two interventions: SLEEP and...

Eligibility Criteria

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

Key Trial Info

Start Date :

December 26 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 31 2027

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06411561

Start Date

December 26 2024

End Date

May 31 2027

Last Update

July 20 2025

Active Locations (1)

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1

University of Washington

Seattle, Washington, United States, 98195