Early Cognitive Intervention in Delirium

NCT04740567 | Completed Results

• 1 other identifier: 192498
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 2

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.

Conditions

Delirium; Cognitive Decline; Dementia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Cognitive Intervention

EXPERIMENTAL

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; Behavioral: Goal Management Training

Usual Care

NO INTERVENTION

Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.

Interventions

Cognitive Training BEHAVIORAL

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.

Cognitive Intervention

Goal Management Training BEHAVIORAL

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.

Cognitive Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Tennessee Valley Healthcare System - Nashville Veteran Affairs Hospital

Nashville, Tennessee, 37027, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37027, United States

Location

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Dementia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Limited generalizability since our study was conducted at a quartnerary hospital in the South. Mortality was different between the intervention vs usual care group and overall attrition rate was high for both groups, which may have biased our estimates.

Results Point of Contact

• Title: Jin H. Han
• Organization: Vanderbilt University Medical Center

jin.h.han@vumc.org

615-936-0253

Study Officials

• Jin H Han, MD, MSc

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• James C Jackson, PsyD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: February 9, 2021
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.

Locations

US (2)