Rehabilitation Gaming System for Intensive Care Units (RGS-ICU)

University of the Balearic Islands

Status

Active, not recruiting

Conditions

Critical Illness

Treatments

Other: Cognitive stimulation and psychological support (RGS-ICU)

Study type

Interventional

Funder types

Other

Identifiers

NCT06267911

160/U/2022 (Other Grant/Funding Number)

202223-10

Details and patient eligibility

About

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.

Enrollment

93 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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