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Cognitive Intervention for Delirium (ECID Trial)

N/A

Waitlist Available

Led By Jin H Han, MD, MSc

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

65 years or older

Be older than 65 years old

Must not have

Comatose

Receiving hospice care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if cognitive training and rehabilitation improve cognition in hospitalized older delirious patients with and without Alzheimer's disease.

Who is the study for?

This trial is for people aged 65 or older who are hospitalized, can start cognitive training within a day of emergency department arrival, and are experiencing delirium. It's not for those with recent heavy drug use, certain psychiatric conditions, living far from the site, non-English speakers, comatose patients, severe pre-existing dementia, nursing home residents or those in hospice care.

What is being tested?

The study tests if early cognitive training helps improve thinking skills in older adults with delirium after hospitalization. Participants will either receive daily cognitive exercises while hospitalized and weekly sessions post-discharge for three months or they'll get usual care without these interventions.

What are the potential side effects?

Since this trial involves cognitive training rather than medication, traditional side effects aren't expected. However participants may experience fatigue or frustration during the exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not in a coma.

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I am currently receiving hospice care.

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I have not been hospitalized for a psychotic disorder or suicide attempt in the past year.

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I do not speak English.

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Before my current illness, I was unable to understand simple commands or communicate non-verbally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Global cognition as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Secondary study objectives

Executive function as measured by the components of the Delis-Kaplan Executive Function System (D-KEFS) subscales

Functional status as measured by Older American Resources and Services Activities of Daily Living Scale

Montreal Cognitive Assessment

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive InterventionExperimental Treatment2 Interventions

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.

Group II: Usual CareActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Training

2008

Completed Phase 3

~4100

Goal Management Training

2017