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Early Cognitive Intervention in Delirium (ECID)

Primary Purpose

Delirium, Cognitive Decline, Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Goal Management Training
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tennessee Valley Healthcare System - Nashville Veteran Affairs Hospital
  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Intervention

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
Vital status (dead / alive)
Death within 4-months will be recorded
Nursing home placement (yes / no)
Nursing home placement within 4-months will be recorded
Montreal Cognitive Assessment
Global cognition measure that assesses visuospatial, language, naming, memory, attention,abstraction, and orientation .

Full Information

First Posted
February 1, 2021
Last Updated
January 17, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04740567
Brief Title
Early Cognitive Intervention in Delirium
Acronym
ECID
Official Title
Early Cognitive Training and Rehabilitation to Improve Long-term Cognitive Outcomes in Older Hospitalized Adults With Delirium
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Cognitive Decline, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Goal Management Training
Intervention Description
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 Outcome Measure Information:
Title
Global cognition as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Description
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.
Time Frame
4-months
Secondary Outcome Measure Information:
Title
Executive function as measured by the components of the Delis-Kaplan Executive Function System (D-KEFS) subscales
Description
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
Time Frame
4-months
Title
Functional status as measured by Older American Resources and Services Activities of Daily Living Scale
Description
Characterizes seven basic and seven instrumental activities of daily living. Scores range from 0 to 28 with higher scores indicating better functional status.
Time Frame
4-months
Title
Quality of life as measured by the EQ-5D-5L
Description
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.
Time Frame
4-months
Title
Vital status (dead / alive)
Description
Death within 4-months will be recorded
Time Frame
4-months
Title
Nursing home placement (yes / no)
Description
Nursing home placement within 4-months will be recorded
Time Frame
4-months
Title
Montreal Cognitive Assessment
Description
Global cognition measure that assesses visuospatial, language, naming, memory, attention,abstraction, and orientation .
Time Frame
4-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Kampe, MAcc
Phone
615-936-0253
Email
christina.kampe@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jin H Han, MD, MSc
Phone
615-936-0253
Email
jin.h.han@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin H Han, MD, MSc
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James C Jackson, PsyD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Valley Healthcare System - Nashville Veteran Affairs Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin H Han
Phone
615-936-0253
Email
jin.h.han@vumc.org
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin H Han
Phone
615-936-0253
Email
jin.h.han@vumc.org

12. IPD Sharing Statement

Plan to Share 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.

Learn more about this trial

Early Cognitive Intervention in Delirium

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