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DeliriumECIDNCT04740567

Early Cognitive Intervention in Delirium

A study testing Cognitive Training and Goal Management Training in people with Delirium and Cognitive Decline, run by Vanderbilt University Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Delirium, Cognitive Decline, Dementia
What is being tested?
Cognitive Training and Goal Management Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
283 participants
Where
2 sitesUnited States
Study dates
9 Feb 2021to 14 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Tennessee Valley Healthcare System - Nashville Veteran Affairs Hospital

    Nashville, Tennessee, 37027

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37027

Other trials in United States

About this study

Official title: 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.

Being tested
Cognitive Training, Goal Management Training
Medical subject headings
Delirium, Cognitive Dysfunction, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive TrainingBehavioural

    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 TrainingBehavioural

    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.

Study groups in NCT04740567
Study groupRoleWhat they receive
Cognitive InterventionExperimentalDuring 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.
Receives: Behavioral: Cognitive Training; Behavioral: Goal Management Training
Usual CareNo interventionEnrolled patients will undergo usual care during hospitalization and post-hospital discharge.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4-months

Secondary outcomes (6)

  1. 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

    Measured: 4-months

  2. 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.

    Measured: 4-months

  3. 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.

    Measured: 4-months

  4. Vital Status (Dead / Alive)

    Death within 4-months will be recorded

    Measured: 4-months

  5. Nursing Home Placement (Yes / no)

    Nursing home placement within 4-months will be recorded

    Measured: 4-months

  6. 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.

    Measured: 4-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start9 Feb 2021
  3. Primary completion14 Nov 2024
  4. Study completion14 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
283 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04740567
Sponsor's protocol ID
192498
Acronym
ECID
Status last verified
Dec 2025
First submitted
1 Feb 2021
Last updated
24 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Training and Goal Management Training in people with Delirium and Cognitive Decline, run by Vanderbilt University Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (time frame: 4-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04740567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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