Early Cognitive Intervention in Delirium (ECID)

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

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.

Study Overview

• Status: Completed
• Conditions: Delirium; Dementia; Cognitive Decline
• Intervention / Treatment: Behavioral: Cognitive Training; Behavioral: Goal Management Training

• Study Type: Interventional
• Enrollment (Actual): 283
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37027
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37027
      • Tennessee Valley Healthcare System - Nashville Veteran Affairs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Intervention; 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.	Behavioral: Cognitive Training; The cognitive training program regimen and its degree of difficulty will be tailored to the patient's current level of cognitive functioning and interests. Patients will be asked to work through progressively more challenging exercises pertaining to orientation, attention, problem-solving, and memory. These cognitive training exercises will be significantly difficult but when they can be completed easily (>85% mastery), their difficulty will be increased, and this process will be repeated as appropriate. They will also perform puzzles, games, or cognitive tasks related to their hobbies.; Behavioral: Goal Management Training; Goal management training will (1) teach patients compensatory strategies such as "stop" techniques [e.g., to "stop and think" about consequences of a decision before making it]; (2) help them to take complex tasks and divide them into manageable subtasks to increase the likelihood of completing the task; and (3) enable them to learn to regain cognitive control when their behavior becomes incompatible with their intended goals. GMT is anchored in "sustained and vigilant attention theory" and it enables patients to actively attend to "higher order" goals critical to functioning. GMT is tailored to the individual needs of the patient. During the initial session, the Cognitive Intervention Specialist will meet with the subject and their family member or caregiver to identify these functional and cognitive deficiencies.
No Intervention: Usual Care; Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	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.	4-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales	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	4-months
Functional Status as Measured by Older American Resources and Services Activities of Daily Living Scale	Characterizes seven basic and seven instrumental activities of daily living. Scores range from 0 to 28 with higher scores indicating better functional status.	4-months
Quality of Life as Measured by the EQ-5D-5L	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.	4-months
Vital Status (Dead / Alive)	Death within 4-months will be recorded	4-months
Nursing Home Placement (Yes / no)	Nursing home placement within 4-months will be recorded	4-months
Change in Montreal Cognitive Assessment	Change in global cognition at 4-months compared to enrollment. The Montreal Cognitive Assessment assesses visuospatial, language, naming, memory, attention, abstraction, and orientation, and ranges from 0 to 30 (perfect cognition). It was collected at enrollment, during the delirium episode, and at 4 months.	4-months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Jin H Han, MD, MSc, Vanderbilt University Medical Center; Principal Investigator: James C Jackson, PsyD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2021
• Primary Completion (Actual): November 14, 2024
• Study Completion (Actual): November 14, 2024

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium; Cognitive Dysfunction; Dementia; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Aftercare; Continuity of Patient Care; Neurological Rehabilitation; Cognitive Training
• Other Study ID Numbers: 192498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Deidentified data will be made available two years after publication. Supporting documents will be made available at the time of publication of the primary manuscript.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No