Early Cognitive Intervention in Delirium

Purpose

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

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cognitive Intervention 		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
    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.
  • Behavioral: 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.
No Intervention
Usual Care 		Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37027
Contact:
Jin H Han
615-936-0253
jin.h.han@vumc.org

More Details

Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Christina Kampe, MAcc
615-936-0253
christina.kampe@vumc.org

For general questions about clinical trials, contact Research Support Services at (615) 322-7343 or research.support.services@vumc.org