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Clinical Trials/NCT04740567
NCT04740567
Completed
N/A

Early Cognitive Training and Rehabilitation to Improve Long-term Cognitive Outcomes in Older Hospitalized Adults With Delirium

Vanderbilt University Medical Center2 sites in 1 country283 target enrollmentFebruary 9, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Delirium
Sponsor
Vanderbilt University Medical Center
Enrollment
283
Locations
2
Primary Endpoint
Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

This is a randomized control trial to determine if early cognitive training and rehabilitation improve 4-month cognition in hospitalized older (>=65 years old) delirious patients with and without Alzheimer's disease and related dementias. Enrolled patients will be randomized to receive cognitive intervention versus usual care at a 1:2 allocation ratio. Patients assigned to the cognitive intervention group will receive cognitive training daily during hospitalization and cognitive rehabilitation weekly for 12 weeks after hospital discharge. Patients will be evaluated for global cognition (primary outcome) and secondary outcomes at 4-months.

Registry
clinicaltrials.gov
Start Date
February 9, 2021
End Date
November 14, 2024
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jin H. Han

Associate Professor

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • 65 years or older
  • Admitted through the ED
  • Cognitive training can be initiated within 24 hours of ED presentation
  • Delirious at enrollment

Exclusion Criteria

  • Not able to follow simple commands or non-verbal prior to the acute illness (end-stage pre-illness ADRD)
  • Resides in a nursing home
  • Receiving hospice care
  • Lives \> 100 miles away from the enrolling sites
  • Non-English speaking
  • Previously enrolled
  • Deaf or blind
  • Intravenous drug, crack or cocaine, or methamphetamine use within the past one year, or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial.
  • Psychotic disorder or suicidal gesture requiring hospitalization with the past one year
  • Discharged from the ED

Outcomes

Primary Outcomes

Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Time Frame: 4-months

A neuropsychological battery for global cognition which evaluates immediate and delayed memory, attention, visuospatial construction, and language. Scores range from 40 to 160, with higher scores indicating better cognition.

Secondary Outcomes

  • Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales(4-months)
  • Functional Status as Measured by Older American Resources and Services Activities of Daily Living Scale(4-months)
  • Quality of Life as Measured by the EQ-5D-5L(4-months)
  • Vital Status (Dead / Alive)(4-months)
  • Nursing Home Placement (Yes / no)(4-months)
  • Change in Montreal Cognitive Assessment(4-months)

Study Sites (2)

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