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Behavioural Intervention
Computerized Cognitive Rehabilitation for ICU Survivorship (RETURN-III Trial)
Phase 2
Recruiting
Led By Mayur B Patel, MD MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults with a recent ICU stay (Medical or Surgical) requiring treatment for respiratory failure and/or shock (i.e., high-risk population)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
RETURN-III Trial Summary
This trial will test whether a computerized cognitive intervention can improve the long-term cognitive impairment suffered by millions of ICU survivors every year.
Who is the study for?
This trial is for adults who've recently been in an ICU due to respiratory failure or shock, are now stable, and live close enough to the study site. It's not for those with severe pre-existing cognitive issues, substance abuse problems that prevent independent living, active suicidal thoughts, or sensory impairments that hinder communication.Check my eligibility
What is being tested?
The RETURN-III trial tests computerized cognitive rehabilitation on patients with post-ICU cognitive impairment. Participants will be randomly assigned to either play control computer games or undergo targeted cognitive rehab exercises designed to improve brain function and structure.See study design
What are the potential side effects?
Since this intervention involves non-invasive computer-based activities, significant side effects are not anticipated. However, participants may experience fatigue or frustration during the tasks.
RETURN-III Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was recently in the ICU for severe breathing problems or shock.
RETURN-III Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Global Cognitive Composite Score
RETURN-III Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Computerized Cognitive RehabilitationExperimental Treatment1 Intervention
Computerized Cognitive Rehabilitation
Group II: Active Control computer gamesActive Control1 Intervention
Active Control computer games
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterOTHER
857 Previous Clinical Trials
672,033 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,124 Total Patients Enrolled
Mayur B Patel, MD MPHPrincipal InvestigatorTennessee Valley Healthcare System Nashville Campus, Nashville, TN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe substance abuse problem or mental illness that makes it difficult for you to live independently.I am currently having thoughts about harming myself.You have engaged in behavior that could potentially harm yourself or others during the study.I live more than 100 miles away and cannot return for follow-up.I was recently in the ICU for severe breathing problems or shock.I needed intensive care for less than a day.I am not willing to participate in the study treatment.I cannot complete training on a computer.I am being considered for hospice care.
Research Study Groups:
This trial has the following groups:- Group 1: Computerized Cognitive Rehabilitation
- Group 2: Active Control computer games
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If a patient is interested, how can they sign up for this clinical trial?
"Yes, this information can be found on the website clinicaltrials.gov. The trial was first posted on October 3rd, 2020 and has been edited recently on October 24th, 2020."
Answered by AI
How many individuals are currently enrolled in this research project?
"That is correct, the online clinicaltrials.gov registry reflects that this study is currently looking for enrollees. The listing was first created on October 3rd, 2020 and underwent its most recent edit on October 24th of the same year. This research project needs 160 individuals from 1 site to participate."
Answered by AI
Does the FDA recognize computerized cognitive rehabilitation as an official treatment method?
"Since this is a Phase 2 trial, meaning that while there are some data supporting safety, none supporting efficacy, we've given Treatment Arm: Computerized Cognitive Rehabilitation a score of 2."
Answered by AI
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