Early Cognitive Intervention in Delirium

Dementia Clinical Trial

— ECID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04740567
• Other study ID #: 192498
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: Christina Kampe, MAcc
• Phone: 615-936-0253
• Email: christina.kampe[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: September 1, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Delirium
• Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Tennessee Valley Healthcare System - Nashville Veteran Affairs Hospital	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

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