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Completed

NCT Number: NCT04740567

Early Cognitive Intervention in 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.

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Key information

Conditions

Delirium Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Decline Cognitive Dysfunction Confusion Dementia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales

    Time frame: 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

  2. Functional Status as Measured by Older American Resources and Services Activities of Daily Living Scale

    Time frame: 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.

  3. Quality of Life as Measured by the EQ-5D-5L

    Time frame: 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.

  4. Vital Status (Dead / Alive)

    Time frame: 4-months

    Death within 4-months will be recorded

  5. Nursing Home Placement (Yes / no)

    Time frame: 4-months

    Nursing home placement within 4-months will be recorded

  6. Change in Montreal Cognitive Assessment

    Time frame: 4-months

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: ECID

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2021
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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