About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
VR-based cognitive training program
DeviceVR-Cog features HomeTown Bound, a suite of 18 modules organized into four training categories: attention, processing speed, memory, and visuospatial.
VR-based attention control
DeviceVR-AC consists of a library of 9 nature scenes (content provided by Nature Treks VR).
Treatment groups
Trial outcomes
Primary outcomes
Measure the feasibility of VR-Cog in older adult ICU delirium survivors
Feasibility will be measured by the percentage (%) of intervention sessions delivered to participants, with greater than or equal to 80% of intervention sessions completed defining feasibility.
Measure the acceptability of VR-Cog in older adult ICU delirium survivors
Acceptability will be defined as scores of 8 or greater on each subscale of the Senior Technology Acceptance Model (STAM, Short Form with 14-items). The four subscales of the STAM measure attitudes towards technology (perceived use and effectiveness), control beliefs (ability to use the technology and complete tasks), gerontologic anxiety (feeling apprehensive or hesitant with technology applications), and general health (ability to concentrate, satisfaction with general health).
Measure the adherence to VR-Cog in older adult ICU delirium survivors
Adherence to the protocol will be assessed through rates of retention at end of 4-week intervention (80% among participants alive and out of the hospital) and completion of outcomes assessments (80% among participants alive and out of the hospital).
Secondary outcomes
Estimate the effect of VR-Cog on cognitive performance among older adult ICU delirium survivors.
Repeatable Battery for Assessment of Neuropsychological Status (RBANS)
Explore the effects of VR-Cog on depression
As measured by Patient Health Questionnaire (PHQ-9)
Explore the effects of VR-Cog on anxiety
As measured by Generalized Anxiety Disorder (GAD-7) scale
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
Indiana University Health
Collaborator