Early Cognitive Intervention in Delirium (ECID)

Vanderbilt University Medical Center

Status: Completed

Conditions: Delirium; Cognitive Decline; Dementia

Treatments: Behavioral: Cognitive Training; Behavioral: Goal Management Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04740567

192498

Details and patient eligibility

About

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.

Enrollment: 283 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

283 participants in 2 patient groups

Cognitive Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Goal Management Training

Behavioral: Cognitive Training

Usual Care

No Intervention group

Description:

Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.