Virtual Reality Cognitive Intervention for Critically Ill Delirium Survivors (VR-Cog)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measure the feasibility of VR-Cog in older adult ICU delirium survivors
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The study team staff performing outcomes assessments will be blinded.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
VR-based cognitive training program
干预措施: VR-based cognitive training program (Device)
VR-based attention control
干预措施: VR-based attention control (Device)
结局指标
主要结局
Measure the feasibility of VR-Cog in older adult ICU delirium survivors
时间窗: 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.
Measure the acceptability of VR-Cog in older adult ICU delirium survivors
时间窗: 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).
Measure the adherence to VR-Cog in older adult ICU delirium survivors
时间窗: 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).
次要结局
- Estimate the effect of VR-Cog on cognitive performance among older adult ICU delirium survivors.(Measured at Baseline, 4 weeks (end of intervention period), 3-Month and 6-Month follow up)
- Explore the effects of VR-Cog on depression(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(Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.)
研究者
Sikandar Khan
Assistant Professor of Medicine
Indiana University