Clinical trial NCT06267911: Rehabilitation Gaming System for Intensive Care Units
Official title: Efficacy and Safety of a Non-immersive Virtual Reality-based Neuropsychological Intervention for Cognitive Stimulation and Psychological Support of Critical Care Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
Collaborators: name: Corporacion Parc Tauli
name: Hospital Son Llatzer
name: Fundació La Marató de TV3
First posted: 2024-02-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Attention performance
timeFrame: 12 months after discharge from the ICU
measure: Working memory performance
timeFrame: 12 months after discharge from the ICU
measure: Learning/memory performance
timeFrame: 12 months after discharge from the ICU
measure: Executive function performance
timeFrame: 12 months after discharge from the ICU
measure: Processing speed performance
timeFrame: 12 months after discharge from the ICU
measure: Incidence of Treatment-Emergent Adverse Events [Safety]
timeFrame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Secondary outcomes:
measure: Dyspnea intensity
timeFrame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
measure: Pain intensity
timeFrame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
measure: Worry intensity
timeFrame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
measure: Sadness intensity
timeFrame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
measure: Comfort experienced
timeFrame: Discharge from the ICU
measure: Anxiety symptoms
timeFrame: 12 months after discharge from the ICU
measure: Symptoms of depression
timeFrame: 12 months after discharge from the ICU
measure: Symptoms of post-traumatic stress disorder
timeFrame: 12 months after discharge from the ICU
Other outcomes:
measure: Objective cognition
timeFrame: 12 months after discharge from the ICU
measure: Subjective cognition
timeFrame: 12 months after discharge from the ICU
measure: Functionality
timeFrame: 12 months after discharge from the ICU
measure: Health-related quality of life
timeFrame: 12 months after discharge from the ICU
Locations:
city: Palma De Mallorca
country: Spain
facility: University of the Balearic Islands
state: Balearic Islands
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Llàtzer
state: Balearic Islands
city: Sabadell
country: Spain
facility: Corporacion Parc Tauli
state: Catalonia
Study officials:
affiliation: University of the Balearic Islands
name: Guillem Navarra-Ventura, PhD
role: PRINCIPAL_INVESTIGATOR
References: