Cognitive rehabilitation for ICU survivors
Returning to Everyday Tasks Utilizing Rehabilitation Networks-III Pilot Randomized Clinical Trial (RETURN-III Pilot RCT)
This study is testing if a computer-based brain training program can help ICU survivors, especially veterans, improve their thinking skills after experiencing long-term cognitive issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Nashville, Tennessee and 1 other locations) |
| Trial ID | NCT04353804 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of computerized cognitive rehabilitation for patients who have experienced long-term cognitive impairment after surviving an intensive care unit (ICU) stay. The intervention aims to harness neuroplasticity to improve cognitive function and brain structure in patients suffering from post-ICU long-term cognitive impairment (ICU-LTCI). A total of 160 participants will be randomized to receive either the cognitive rehabilitation or an active control involving computer games. The study is designed to address a significant unmet need in the rehabilitation of ICU survivors, particularly among veterans.
Who should consider this trial
Good fit: Ideal candidates are adults who have recently stayed in an ICU for respiratory failure or shock and no longer require ICU-level care.
Not a fit: Patients with severe pre-existing cognitive impairments or those unable to participate in computer-based training may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive function and quality of life for ICU survivors.
How similar studies have performed: Previous studies have indicated the potential for cognitive rehabilitation approaches to improve outcomes in similar patient populations, suggesting this intervention may build on established findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee and 1 other locations
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: E. Wesley Ely, MD MPH — Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
- Study coordinator: Mayur B Patel, MD MPH
- Email: Mayur.Patel2@va.gov
- Phone: (615) 873-7214
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.