Virtual Reality Cognitive Intervention for Critically Ill Delirium Survivors (VR-Cog)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR-based cognitive training program, VR-based attention control.
- Who it may be relevant to
- Registry conditions: Intensive Care Unit Delirium, Intensive Care Acquired Cognitive Impairment, Post Intensive Care Unit Syndrome, Virtual Reality Cognitive Training. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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).
Interventions
- Device VR-based cognitive training program
VR-Cog features HomeTown Bound, a suite of 18 modules organized into four training categories: attention, processing speed, memory, and visuospatial. - Device VR-based attention control
VR-AC consists of a library of 9 nature scenes (content provided by Nature Treks VR).
Primary outcome measures
- Measure the feasibility of VR-Cog in older adult ICU delirium survivors [Time frame: Feasibility will be measured at 4 weeks (the end of the intervention period)]
- Measure the acceptability of VR-Cog in older adult ICU delirium survivors [Time frame: Acceptability will be measured at 4 weeks (the end of the intervention period)]
- Measure the adherence to VR-Cog in older adult ICU delirium survivors [Time frame: Adherence will be measured at 4 weeks (the end of the intervention period)]
Secondary outcome measures (3)
- Estimate the effect of VR-Cog on cognitive performance among older adult ICU delirium survivors. [Time frame: Measured at Baseline, 4 weeks (end of intervention period), 3-Month and 6-Month follow up]
- Explore the effects of VR-Cog on depression [Time frame: Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.]
- Explore the effects of VR-Cog on anxiety [Time frame: Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- IU Health Methodist Hospital — Indianapolis
Identifiers
NCT: NCT07496255 · 28520