IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
NCT Number: NCT07496255
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
VR-Cog features HomeTown Bound, a suite of 18 modules organized into four training categories: attention, processing speed, memory, and visuospatial.
Other names: VR-Cog
VR-AC consists of a library of 9 nature scenes (content provided by Nature Treks VR).
Other names: VR-AC
Time frame: Feasibility will be measured at 4 weeks (the end of the intervention period)
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.
Time frame: Acceptability will be measured at 4 weeks (the end of the intervention period)
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).
Time frame: Adherence will be measured at 4 weeks (the end of the intervention period)
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).
Time frame: Measured at Baseline, 4 weeks (end of intervention period), 3-Month and 6-Month follow up
Repeatable Battery for Assessment of Neuropsychological Status (RBANS)
Time frame: Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.
As measured by Patient Health Questionnaire (PHQ-9)
Time frame: Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.
As measured by Generalized Anxiety Disorder (GAD-7) scale
Contact information is provided by the study sponsor or research team.
Lori Rawlings, RN, BSN
CONTACT
Sikandar Khan, DO, MS
CONTACT
Indiana University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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