RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 VA patients with ICU-LTCI. The investigators hypothesize that this intervention could improve cognition, and brain structure shown by MRI. This research has high potential to influence rehabilitation strategies for Veteran and civilian ICU survivors.

Official Title

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

Quick Facts

Study Start:2022-10-03
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04353804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults with a recent ICU stay (Medical or Surgical) requiring treatment for respiratory failure and/or shock (i.e., high-risk population)
  2. * No longer requiring ICU-level care
  1. * No history of pre-existing severe cognitive impairment (IQCODE\<3.3, documentation in medical record)
  2. * Unwilling to commit to participation in the intervention
  3. * Under consideration for hospice
  4. * Primary residence over 100 miles from enrolling site if the patient is unwilling to return to the enrolling site for follow-up
  5. * Homeless without a secondary contact available
  6. * Severe substance abuse or neuropsychiatric disorder of a severity that prevents independent living
  7. * Active suicidal ideation
  8. * Any past or present behavior that may be deemed a safety risk for follow-up
  9. * Blind, deaf, or unable to understand/communicate in English
  10. * Required ICU level care less than 24 hours
  11. * Not capable of completing computer-based training

Contacts and Locations

Study Contact

Mayur B Patel, MD MPH
CONTACT
(615) 873-7214
Mayur.Patel2@va.gov
E. Wesley Ely, MD MPH
CONTACT
(615) 873-6055
wes.ely@vumc.org

Principal Investigator

E. Wesley Ely, MD MPH
PRINCIPAL_INVESTIGATOR
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Mayur B Patel, MD MPH
PRINCIPAL_INVESTIGATOR
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Study Locations (Sites)

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • E. Wesley Ely, MD MPH, PRINCIPAL_INVESTIGATOR, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
  • Mayur B Patel, MD MPH, PRINCIPAL_INVESTIGATOR, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-03
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-10-03
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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