Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04353804

Returning to Everyday Tasks Utilizing Rehabilitation Networks-III (RETURN-III)

Led by VA Office of Research and Development · Updated on 2026-03-13

160

Participants Needed

2

Research Sites

251 weeks

Total Duration

On this page

Sponsors

V

VA Office of Research and Development

Lead Sponsor

V

Vanderbilt University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Millions of patients survive care in medical and surgical Intensive Care Units (ICUs) every year, only to suffer from a new or accelerated dementia-like process, called post-ICU long-term cognitive impairment (ICU-LTCI). ICU-LTCI causes considerable problems with personal relationships, return to work, and everyday tasks, such as managing medicines and money. No treatment for these patients is currently available. Technology using computerized cognitive rehabilitation could improve ICU-LTCI by harnessing the healing potential of the brain (i.e., neuroplasticity). This intervention is scalable, portable, and economical. The investigators will evaluate the effectiveness of computerized cognitive rehabilitation in a randomized controlled trial of 160 ICU survivors. The investigators hypothesize that this intervention could improve cognition. This research has high potential to influence rehabilitation strategies for Veteran and civilian ICU survivors.

CONDITIONS

Official Title

Returning to Everyday Tasks Utilizing Rehabilitation Networks-III (RETURN-III)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with a recent medical or surgical ICU stay requiring treatment for respiratory failure and/or shock
  • No longer requiring ICU-level care
Not Eligible

You will not qualify if you...

  • History of severe cognitive impairment before ICU (IQCODE≥3.8 or documented in medical record)
  • Unwilling to participate in the intervention
  • Under consideration for hospice care
  • Primary residence over 100 miles from enrolling site without willingness to return for follow-up
  • Homeless without a secondary contact available
  • Severe substance abuse or neuropsychiatric disorder preventing independent living
  • Active suicidal thoughts
  • Any past or present behavior posing safety risks for follow-up
  • Blind, deaf, or unable to understand or communicate in English
  • Required ICU-level care for less than 24 hours
  • Unable to complete computer-based training
  • Enrolled in another study
  • Currently incarcerated

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, United States, 37212-2637

Actively Recruiting

2

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212

Actively Recruiting

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Research Team

M

Mayur B Patel, MD MPH

CONTACT

E

E. Wesley Ely, MD MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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