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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
VA Office of Research and Development
Study ID
NCT04353804
Status
Recruiting
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Conditions

  • Cognitive Rehabilitation
  • ICU
  • ICU Survivorship
  • Intensive Care Unit

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Treatment Arm: Computerized Cognitive Rehabilitation — OTHER
    Treatment Arm: Computerized Cognitive Rehabilitation
  • Active Control computer games — OTHER
    Active Control computer games

Study Details

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.

Key Dates

Start date
Oct 3, 2022
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Computerized Cognitive Rehabilitation
    Computerized Cognitive Rehabilitation
  • Active Comparator: Active Control computer games
    Active Control computer games

Primary Outcome Measure

Global Cognitive Composite Score [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Tennessee Valley Healthcare System Nashville Campus, Nashville, TNNashvilleTennessee37212-2637
Matthew G Francis
[email protected]
615-873-8694
Talat A Ikizler, MD
[email protected]
(615) 873-7526
E. Wesley Ely, MD MPH (PRINCIPAL_INVESTIGATOR)
Mayur B Patel, MD MPH (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37212
Mayur B Patel, MD
[email protected]
615-322-5000
E. Wesley Ely, MD
[email protected]
6153225000

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By research site
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN· Nashville, TNVanderbilt University Medical Center· Nashville, TN

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