Efficacy and Safety of a Non-immersive Virtual Reality-based Neuropsychological Intervention for Cognitive Stimulation and Psychological Support of Critical Care Patients
概览
- 阶段
- 不适用
- 干预措施
- Cognitive stimulation and psychological support (RGS-ICU)
- 疾病 / 适应症
- Critical Illness
- 发起方
- University of the Balearic Islands
- 入组人数
- 93
- 试验地点
- 3
- 主要终点
- Executive function performance
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
Admission to an Intensive Care Unit (ICU) is a potentially traumatic experience for a mentally vulnerable person. Beyond the stress and anxiety associated with the ICU environment and medical procedures, survivors of critical illness are at risk of developing cognitive and psychological sequelae related to Post-Intensive Care Syndrome (PICS). These disorders are associated with high economic, medical and personal costs.
This trial aims to evaluate the efficacy of an innovative neuropsychological e-health intervention for early cognitive stimulation and psychological support of people in critical care, i.e. the Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) intervention, in improving comfort during ICU admission and cognition and mental health three and 12 months after ICU discharge. The RGS-ICU intervention, applied as an adjunct to standard ICU care, is based on non-immersive virtual reality techniques and has been specifically designed and developed to suit the needs of people in critical care and the characteristics of the ICU environment. To ensure the safety of the intervention, participants' physiological parameters will be automatically recorded by advanced continuous monitoring systems as part of standard ICU care.
The investigators hypothesize that the cognitive stimulation and psychological support protocols of the RGS-ICU intervention, applied as an adjunct to standard ICU care, in addition to being safe for people in critical care units, will improve comfort during ICU admission and cognitive and mental health outcomes after ICU discharge, compared to receiving standard ICU care alone.
The findings derived from this trial may contribute to establish a novel and superior paradigm of human-centered ICU care to improve the comfort of people admitted to the ICU. This achievement could also have a relevant impact on medical and economic costs during ICU admission, and on functionality and health-related quality of life after ICU discharge associated with the reduction of cognitive and psychological sequelae linked to PICS.
The RGS-ICU intervention has been designed at Corporacion Parc Taulí with the collaboration of the University of the Balearic Islands and has been developed by Eodyne Systems S.L., a company dedicated to the development of science-based technological solutions for intervention, monitoring, diagnosis, and prognosis in stroke and other brain disorders.
研究者
入排标准
入选标准
- •Adult patients (≥18 years)
- •Admitted to a medical/surgical ICU
- •For respiratory failure, cardiogenic shock, or septic shock
- •With an expected ICU stay of ≥48 hours
- •Residing in Catalonia or Majorca (Balearic Islands)
- •Who speak Catalan and/or Spanish
- •Who are able to give informed consent by themselves or through an authorized representative
排除标准
- •History of intellectual disability or other neurodevelopmental disorders, such as autism spectrum disorder
- •History of neurological disorders, dementia or other neurodegenerative diseases, such as epilepsy, Alzheimer's disease, Parkinson's disease or multiple sclerosis
- •History of brain damage, such as traumatic brain injury or stroke
- •History of severe psychiatric illness, such as psychotic, bipolar, depressive, obsessive-compulsive, post-traumatic or personality disorder
- •Suspected or confirmed substance use disorder
- •Suspected or confirmed communicable disease in an isolated patient
- •Uncorrected hearing or visual impairment
- •Any medical condition that prevents safe upper extremity mobility, such as skin lesions, burns, or fractures
- •Life expectancy \<12 months
- •Enrolled in another trial that does not allow co-enrollment
研究组 & 干预措施
Cognitive stimulation and psychological support (RGS-ICU)
干预措施: Cognitive stimulation and psychological support (RGS-ICU)
Treatment as usual (TAU)
结局指标
主要结局
Executive function performance
时间窗: 12 months after discharge from the ICU
Difference in executive function performance (Z scores) between experimental and non-intervention groups assessed with the Trail Making Test (TMT), the Stroop Color and Word Test (SCWT), and the verbal phonemic fluency (FAS) test 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better executive function performance.
Working memory performance
时间窗: 12 months after discharge from the ICU
Difference in working memory performance (Z scores) between experimental and non-intervention groups assessed with the WAIS-IV Backward Digit Span subtest 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better working memory performance.
Learning/memory performance
时间窗: 12 months after discharge from the ICU
Difference in learning/memory performance (Z scores) between experimental and non-intervention groups assessed with the Rey Auditory Verbal Learning Test (RAVLT) 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better learning/memory performance.
Attention performance
时间窗: 12 months after discharge from the ICU
Difference in attention performance (Z scores) between experimental and non-intervention groups assessed with the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Forward Digit Span subtest 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better attention performance.
Incidence of Treatment-Emergent Adverse Events [Safety]
时间窗: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Number of interrupted sessions due to adverse events in the patients' physiological parameters (oxygen saturation, respiratory rate and heart rate) during admission to the ICU. The higher the number of interrupted sessions, the less safe the intervention.
Processing speed performance
时间窗: 12 months after discharge from the ICU
Difference in processing speed performance (Z scores) between experimental and non-intervention groups assessed with the WAIS-IV Digit Symbol-Coding subtest and the Symbol Digit Modalities Test (SDMT) 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better executive function performance.
次要结局
- Worry intensity(From ICU admission to ICU discharge or up to a maximum of 28 days after randomization)
- Pain intensity(From ICU admission to ICU discharge or up to a maximum of 28 days after randomization)
- Comfort experienced(Discharge from the ICU)
- Dyspnea intensity(From ICU admission to ICU discharge or up to a maximum of 28 days after randomization)
- Anxiety symptoms(12 months after discharge from the ICU)
- Sadness intensity(From ICU admission to ICU discharge or up to a maximum of 28 days after randomization)
- Symptoms of depression(12 months after discharge from the ICU)
- Symptoms of post-traumatic stress disorder(12 months after discharge from the ICU)