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Cognitive Intervention for Delirium (ECID Trial)
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-months
Awards & highlights
ECID Trial 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.Check my eligibility
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.See study design
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.
ECID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 years old or older.
ECID Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Global cognition as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Secondary outcome measures
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 moreECID 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
N/A
~1160
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
671,911 Total Patients Enrolled
18 Trials studying Delirium
5,988 Patients Enrolled for Delirium
National Institute on Aging (NIA)NIH
1,674 Previous Clinical Trials
28,020,623 Total Patients Enrolled
35 Trials studying Delirium
38,343 Patients Enrolled for Delirium
Jin H Han, MD, MScPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
498 Total Patients Enrolled
2 Trials studying Delirium
498 Patients Enrolled for Delirium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was recently discharged from the emergency department.I am not in a coma.I am currently receiving hospice care.I have not been hospitalized for a psychotic disorder or suicide attempt in the past year.I can start cognitive training within a day of visiting the emergency department.You are confused or disoriented when you join the study.I am 65 years old or older.I do not speak English.Before my current illness, I was unable to understand simple commands or communicate non-verbally.You cannot hear or see.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment currently open for this trial?
"Affirmative, clinicaltrials.gov shows that this particular trial is currently open for recruitment of patients. The study was initially made available on February 9th 2021 with its latest update taking place on March 19th 2022. There are 280 slots to fill across two centres."
Answered by AI
What is the uppermost limit of participants in this clinical trial?
"Yes, records on clinicaltrials.gov affirm that this investigation is actively enrolling participants. It was initially published on February 9th 2021 and subsequently modified most recently on March 19th 2022. The research requires 280 patients to be recruited from 2 distinct sites."
Answered by AI
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