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NCT04353804 · ClinicalTrials.gov registry record · NA
Returning to Everyday Tasks Utilizing Rehabilitation Networks-III (RETURN-III)
A NA study of ICU and Intensive Care Unit, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 160
- Enrollment target
- 2
- Study locations
NCT04353804: Recruiting NA study of ICU and Intensive Care Unit, sponsored by VA Office of Research and Development.
NCT04353804 is a NA study of ICU and Intensive Care Unit that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 160 participants, below the 179-participant average among 3 other ICU trials with a reported enrollment target (11% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04353804, a NA study of ICU and Intensive Care Unit, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Treatment Arm: Computerized Cognitive Rehabilitation
- OTHER Active Control computer games
Study Locations (2)
Tennessee
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN - Nashville
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2027-07-31 |
| Phase | NA |
What NCT04353804 shows while recruiting
NCT04353804 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 179-participant average among 3 other ICU trials with a reported enrollment target (11% lower).
The record links to 4 conditions, with ICU appearing as the primary indexed condition, and to 2 interventions - of which Treatment Arm: Computerized Cognitive Rehabilitation is the first listed.
NCT04353804 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04353804 about?
NCT04353804 is a clinical study titled "Returning to Everyday Tasks Utilizing Rehabilitation Networks-III (RETURN-III)". 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 wo...
What is the current status of trial NCT04353804?
This trial is currently recruiting. It is a NA study. The enrollment target is 160 participants. The study started on 2022-10-03. Estimated completion is 2027-07-31.
What conditions does trial NCT04353804 study?
This clinical trial studies the following conditions: ICU, Intensive Care Unit, Cognitive Rehabilitation, ICU Survivorship.
What interventions are being tested in trial NCT04353804?
The interventions under investigation include: Treatment Arm: Computerized Cognitive Rehabilitation (OTHER), Active Control computer games (OTHER).
Who is sponsoring clinical trial NCT04353804?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04353804 being conducted?
This trial has 2 study locations across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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