Clinical trial NCT04740567: Early Cognitive Intervention in Delirium
Official title: Early Cognitive Training and Rehabilitation to Improve Long-term Cognitive Outcomes in Older Hospitalized Adults With Delirium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Cognitive Decline
Dementia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-02-05
Enrollment: 283
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Global cognition as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: 4-months
Secondary outcomes:
measure: Executive function as measured by the components of the Delis-Kaplan Executive Function System (D-KEFS) subscales
timeFrame: 4-months
measure: Functional status as measured by Older American Resources and Services Activities of Daily Living Scale
timeFrame: 4-months
measure: Quality of life as measured by the EQ-5D-5L
timeFrame: 4-months
measure: Vital status (dead / alive)
timeFrame: 4-months
measure: Nursing home placement (yes / no)
timeFrame: 4-months
measure: Montreal Cognitive Assessment
timeFrame: 4-months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Valley Healthcare System - Nashville Veteran Affairs Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jin H Han, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: James C Jackson, PsyD
role: PRINCIPAL_INVESTIGATOR
References: