Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04353804
Other study ID # D2992-R
Secondary ID 1506673-1I01RX00
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 3, 2022
Est. completion date December 31, 2026

Study information

Verified date March 2024
Source VA Office of Research and Development
Contact Mayur B Patel, MD MPH
Phone (615) 873-7214
Email Mayur.Patel2@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Description:

Over a lifetime, an average American will be admitted to an intensive care unit (ICU) twice, will spend nearly a week in an ICU during their last six months of life, and will have a one in five chance of an ICU-related death. Of those millions who annually survive critical illness, ICU survivorship is marked by an inability to manage medication, handle finances, live independently, and maintain employment due to post-ICU long-term cognitive impairment (ICU-LTCI). Data from the investigators' group and others show that 50% of ICU survivors suffer from ICU-LTCI. The investigators' Veterans Affairs (VA) Merit Award funded research, "Measuring the Incidence and determining risk factors for Neuropsychological Dysfunction in ICU Survivors" (MIND-ICU) study, helped define the epidemiology of this persistent and progressive chronic brain dysfunction that affects both executive function and memory domains of cognition. Among survivors from medical and surgical ICUs, 40% have impairments rivaling moderate traumatic brain injury, and 30% have impairments similar to mild-moderate Alzheimer's disease. The MIND-ICU study indicates that the number of Veterans who develop ICU-LTCI is as high as the number of new traumatic brain injury diagnoses among all Active Duty, National Guard, and Reserves of the Army, Navy, Air Force and Marine Corps. For a public health problem of this magnitude, there is a driving unmet need to find solutions for ICU-LTCI. The investigators' pilot randomized "Returning to Everyday Tasks Utilizing Rehabilitation Networks-I" (RETURN-I) Study showed that a 12-week cognitive rehabilitation intervention (vs. controls) improved executive dysfunction. Next, the investigators transformed this non-computerized, resource-intensive strategy into a novel, efficient, and scalable Computerized Cognitive Rehabilitation (CCR) method. This plasticity-based adaptive CCR was applied to a case-series of ICU survivors which signaled improvements across multiple cognitive domains. Building on nearly two decades of aging brain research with the VA-Tennessee Valley Geriatric Research, Education and Clinical Center (GRECC), the investigators now propose a Phase II randomized controlled trial (RCT) to investigate the efficacy of CCR for survivors with ICU-LTCI. The Returning to Everyday Tasks Utilizing Rehabilitation Networks-III Study (RETURN-III Study) will be the next logical data-driven approach to develop and offer innovative real-world solutions for civilians and Veterans surviving critical illness with disabling ICU-LTCI. To test these hypotheses, the RETURN-III study will randomize medical and surgical VA ICU survivors to either intervention using CCR, or control of non-specific computer games. At three, and twelve months post-randomization, trained research personnel blinded to group assignment will use a validated battery to assess global cognition [primary outcome].


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: - No history of pre-existing severe cognitive impairment (IQCODE<3.3, 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

Study Design


Intervention

Other:
Treatment Arm: Computerized Cognitive Rehabilitation
Treatment Arm: Computerized Cognitive Rehabilitation
Active Control computer games
Active Control computer games

Locations

Country Name City State
United States Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
VA Office of Research and Development Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04361032 - Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia Phase 3
Completed NCT03520023 - Critical Care and Palliative Care Medicine Together in the ICU N/A
Completed NCT01169571 - Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients N/A
Completed NCT01168128 - PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study N/A
Recruiting NCT05029167 - REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study) N/A
Recruiting NCT06176807 - Prediction of Acute Kidney Injury in Patients With Sepsis Using Venous Excess Ultrasound Score
Not yet recruiting NCT05367011 - Therapeutic Monitoring of Antibiotics in Intensive Care Patients: a Cohort Study PopTDM-ICU
Recruiting NCT05056090 - Effect of Prone Positioning on Mortality in Patients With Mild to Moderate Acute Respiratory Distress Syndrome. N/A
Completed NCT04503135 - Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit
Completed NCT03983044 - Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery
Completed NCT05573659 - Capillary Refill Time Calculated With a Video-assisted Method Has a Better Reproducibility Than Visual Method in Critically Ill Patients N/A
Completed NCT06032169 - Ankle Measurements of Arterial Pressure: Semi-recumbent or Horizontal Position.
Completed NCT04199273 - Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking N/A
Completed NCT03681626 - Does Tracheal Suction During Extubation in Intensive Care Unit Decrease Functional Residual Capacity N/A
Recruiting NCT04094428 - Burden, Mortality and Supply Costs in Intensive Care Unit Patients
Completed NCT04014920 - Non-invasive Ventilation Following Extubation (Prophylactic) to Prevent Extubation Failure in Critically Obese Patients N/A
Completed NCT05131633 - Regional Anaesthesia in Intensive Care Unit
Completed NCT06239987 - The Effect of Care-oriented Practical Training on Nurses' Intensive and Critical Care Competency and HAIs Indicators N/A
Completed NCT06121024 - Long-term Outcomes of Post-intubation Tracheal Stenosis; 7-year Follow-up
Completed NCT04620005 - Impact of Extra Corporal Membrane Oxygenation Services on Burnout Development in Intensive Care Units.