N/A
N=283
Early Cognitive Intervention in Delirium
Delirium · Cognitive Decline · Dementia
Bottom Line
View on ClinicalTrials.gov: NCT04740567 ↗Enrolled (actual)
283
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) — 67; 67 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Training (Behavioral); Goal Management Training (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) |
67; 67 | — |
| SECONDARY Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales |
5.5; 4.0 | — |
| SECONDARY Functional Status as Measured by Older American Resources and Services Activities of Daily Living Scale |
9; 8 | — |
| SECONDARY Quality of Life as Measured by the EQ-5D-5L |
0.352; 0.269 | — |
| SECONDARY Vital Status (Dead / Alive) |
31; 43 | — |
| SECONDARY Nursing Home Placement (Yes / no) |
2; 2 | — |
| SECONDARY Change in Montreal Cognitive Assessment |
3.5; 4 | — |
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
Data sourced from ClinicalTrials.gov (NCT04740567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.