RecruitingNot ApplicableNCT04353804

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

Returning to Everyday Tasks Utilizing Rehabilitation Networks-III Pilot Randomized Clinical Trial (RETURN-III Pilot RCT)


Sponsor

VA Office of Research and Development

Enrollment

160 participants

Start Date

Oct 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Adults with a recent ICU stay (Medical or Surgical) requiring treatment for respiratory failure and/or shock (i.e., high-risk population)
  • No longer requiring ICU-level care

Exclusion Criteria13

  • History of pre-existing severe cognitive impairment (IQCODE\>=3.8 or documentation in medical record)
  • Unwilling to commit to participation in the intervention
  • Under consideration for hospice
  • Primary residence over 100 miles from enrolling site if the patient is unwilling to return to the enrolling site for follow-up
  • Homeless without a secondary contact available
  • Severe substance abuse or neuropsychiatric disorder of a severity that prevents independent living
  • Active suicidal ideation
  • Any past or present behavior that may be deemed a safety risk for follow-up
  • Blind, deaf, or unable to understand/communicate in English
  • Required ICU level care less than 24 hours
  • Not capable of completing computer-based training
  • Co-enrollment in another study
  • Incarcerated

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Interventions

OTHERTreatment Arm: Computerized Cognitive Rehabilitation

Treatment Arm: Computerized Cognitive Rehabilitation

OTHERActive Control computer games

Active Control computer games


Locations(2)

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT04353804


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