Returning to Everyday Tasks Utilizing Rehabilitation Networks-III (RETURN-III)
RETURN-III
4 other identifiers
interventional
160
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 20, 2020
CompletedStudy Start
First participant enrolled
October 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
March 13, 2026
March 1, 2026
3.8 years
April 16, 2020
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global Cognitive Composite Score
Global Cognitive Composite Score derived from the composite score provided by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS, range 40-160). The higher the number, the better the outcome.
3 months
Study Arms (2)
Computerized Cognitive Rehabilitation
EXPERIMENTALComputerized Cognitive Rehabilitation
Active Control computer games
ACTIVE COMPARATORActive Control computer games
Interventions
Treatment Arm: Computerized Cognitive Rehabilitation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Study Officials
- PRINCIPAL INVESTIGATOR
E. Wesley Ely, MD MPH
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
- PRINCIPAL INVESTIGATOR
Mayur B Patel, MD MPH
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The result of this randomization will be double-blinded, both to the study personnel and participants. All participants will access the computerized cognitive rehabilitation software (or control programs) via the same mechanism. Only specific support staff provided by our industry partner for purposes of training participants on the devices will have knowledge of the participant's randomization category other than the biostatisticians.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2020
First Posted
April 20, 2020
Study Start
October 3, 2022
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2027
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The investigators will share data de-identified \>12 months after study publication in accordance to clinical trial best practices and complying with federal guidelines for research.
- Access Criteria
- The investigators will share data de-identified after study publication in accordance to clinical trial best practices and complying with federal guidelines for research for an unlimited period of time.
The investigators will share data de-identified after study publication in accordance to clinical trial best practices and complying with federal guidelines for research.