NCT04353804 Returning to Everyday Tasks Utilizing Rehabilitation Networks-III (RETURN-III)
| NCT ID | NCT04353804 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Cognitive Rehabilitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-10-03 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2022-10-03 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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 & Investigator
E. Wesley Ely, MD MPH
PRINCIPAL INVESTIGATOR
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Frequently Asked Questions
Who can join the NCT04353804 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cognitive Rehabilitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04353804 currently recruiting?
Yes, NCT04353804 is actively recruiting participants. Contact the research team at Mayur.Patel2@va.gov for enrollment information.
Where is the NCT04353804 trial being conducted?
This trial is being conducted at Nashville, United States, Nashville, United States.
Who is sponsoring the NCT04353804 clinical trial?
NCT04353804 is sponsored by VA Office of Research and Development. The principal investigator is E. Wesley Ely, MD MPH at Tennessee Valley Healthcare System Nashville Campus, Nashville, TN. The trial plans to enroll 160 participants.