Study Results
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View full resultsBasic Information
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COMPLETED
NA
283 participants
INTERVENTIONAL
2021-02-09
2024-11-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Usual Care
Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Admitted through the ED
* Cognitive training can be initiated within 24 hours of ED presentation
* Delirious at enrollment
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Jin H. Han
Associate Professor
Principal Investigators
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Jin H Han, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
James C Jackson, PsyD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Tennessee Valley Healthcare System - Nashville Veteran Affairs Hospital
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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192498
Identifier Type: -
Identifier Source: org_study_id