Virtual Reality Cognitive Intervention for Critically Ill Delirium Survivors (VR-Cog)
Purpose
The purpose of this study is to measure the feasibility, acceptability of virtual reality (VR) brain games and estimate their effect on memory, attention, and mood for ICU survivors. The VR program will be used at home through a headset and hand controls.
Conditions
- Intensive Care Unit Delirium
- Intensive Care Acquired Cognitive Impairment
- Post Intensive Care Unit Syndrome
- Virtual Reality Cognitive Training
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adults aged 50 years or older - English speaking - Admitted to the intensive care unit (ICU) with acute respiratory failure/invasive mechanical ventilation - Screening positive for delirium (using Richmond Agitation Sedation Scale and Confusion Assessment Method for the ICU)
Exclusion Criteria
- Acute neurologic injury such as stroke, traumatic brain injury, brain mass, intracranial hemorrhage, seizures, or central nervous system infection - Chronic cognitive or physical function deficit preventing participation in study interventions or assessments (determined by chart diagnoses and direct participant interview) - Chronic cognitive impairment (including mild cognitive impairment or dementia) identified by chart diagnosis, prescription of anti-dementia medications, or Informant Questionnaire on Cognitive Decline in the Elderly Score (IQCODE) >3.3 obtained from family caregiver - Severe, uncorrected vision or hearing impairment preventing participation in intervention or outcomes assessments - Admitted with acute alcohol or drug intoxication or withdrawal - Severe, uncontrolled psychiatric disorder (bipolar disorder or schizophrenia) - History of severe vertigo, motion-induced sickness, headaches, light sensitivity, seizures, or prior intolerance of virtual reality (VR) - Receiving comfort care measures or not expected to survive the hospitalization - Prisoners or patients unable to provide consent - Not expected to be discharged home from the hospital, or living more than 50 miles from the nearest recruitment site, or homeless
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- VR-based cognitive training program (VR-Cog) vs. VR-based attention control (VR AC)
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
- Masking Description
- The study team staff performing outcomes assessments will be blinded.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VR-based cognitive training program |
|
|
|
Placebo Comparator VR-based attention control |
|
Recruiting Locations
Indianapolis, Indiana 46202
More Details
- Status
- Recruiting
- Sponsor
- Indiana University
Detailed Description
Acute respiratory failure (ARF) accounts for 2 million admissions to adult intensive care units (ICUs) in the United States annually, and up to 80% of older adults with ARF suffer delirium, a form of ICU-related acute brain dysfunction. Delirium doubles the risk for new cognitive impairment or dementia within 12 months of ICU discharge. In addition, delirium survivors frequently develop related mental health and quality of life impairments. Unfortunately, there are few effective or scalable interventions to improve cognitive outcomes for ICU survivors. Primary Objective Aim 1: Measure the feasibility, acceptability, and adherence of VR-Cog in older adult ICU delirium survivors at risk for ICU-acquired MCI and ADRD. Secondary Objective Aim 2: Estimate the effect of VR-Cog on cognitive performance among older adult ICU delirium survivors. Tertiary/Exploratory/Correlative Objectives Aim 3: Explore the effects of VR-Cog on mental health (depression and anxiety).