Early Cognitive Intervention in Delirium

Not Applicable

Completed

• Conditions: Delirium; Cognitive Decline; Dementia
• Interventions: Behavioral: Cognitive Training; Behavioral: Goal Management Training

• Registration Number: NCT04740567
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-05
• Study Start: 2021-02-09
• Primary Completion: 2024-11-14
• Study Completion: 2024-11-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

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

• Comatose
• Not able to follow simple commands or non-verbal prior to the acute illness (end-stage pre-illness ADRD)
• Resides in a nursing home
• Prisoner
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Intervention	Cognitive Training	During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.
Cognitive Intervention	Goal Management Training	During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.

Primary Outcome Measures

Name	Time	Method
Global cognition as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	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 Outcome Measures

Name	Time	Method
Vital status (dead / alive)	4-months	Death within 4-months will be recorded
Montreal Cognitive Assessment	4-months	Global cognition measure that assesses visuospatial, language, naming, memory, attention,abstraction, and orientation .
Executive function as measured by the components of the Delis-Kaplan Executive Function System (D-KEFS) subscales	4-months	The D-KEF's Proverbs, Color Word Interference, and Verbal Fluency Category Switching subscales will measure conceptual flexibility, inhibition, and monitoring, respecitvely, which encompasses the majority of executive function. The average of the three subscales will provide an executive function composite score. Scores range from 1 to 18 with higher values indicating better executive function
Functional status as measured by Older American Resources and Services Activities of Daily Living Scale	4-months	Characterizes seven basic and seven instrumental activities of daily living. Scores range from 0 to 28 with higher scores indicating better functional status.
Quality of life as measured by the EQ-5D-5L	4-months	Characterizes quality of life and contains 5-dimensions ("5D") related to everyday living: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It asks patients to rate their current global health status from 0 (worst health you can imagine) to 100 (best health you can imagine). Scores range from -0.573 to 1.000 with higher scores indicating better quality of life.
Nursing home placement (yes / no)	4-months	Nursing home placement within 4-months will be recorded

Trial Locations

Locations (2)

Tennessee Valley Healthcare System - Nashville Veteran Affairs Hospital; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States