Clinical trial NCT06155721: Development and Evaluation of Virtual Reality Experiences for Cognitive Stimulation at the Sociosanitary Center El Carme
Official title: Desarrollo y evaluación de Experiencias en Realidad Virtual Para la estimulación Cognitiva en el Centro Sociosanitario El Carme de Badalona Servicios Asistenciales (BSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Dysfunction
Mild Cognitive Impairment
Keywords: Cognitive Stimulation
Virtual Reality
Mild Cognitive Impairment
Cognitive Rehabilitation
Lead sponsor: Badalona Serveis Assistencials
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Barcelona
name: Reality Telling SL
First posted: 2023-12-04
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm interventional study where all participants receive the same intervention- a cognitive stimulation program administered through virtual reality (VR). Participants with mild to moderate cognitive impairment will engage in structured VR sessions aimed at stimulating cognitive functions, particularly attention and memory. The study will monitor participants' cognitive performance through standardized cognitive scales pre- and post-intervention, as well as gather subjective feedback on their experience to evaluate acceptability and motivation. Additionally, healthcare professionals' perceptions of the VR intervention's applicability to clinical practice will be assessed through structured interviews or questionnaires.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test a virtual reality (VR)-based program designed for cognitive stimulation in individuals attending the conventional cognitive rehabilitation program at the Day Hospital of CSSC (Centro Sociosanitario El Carme) in Badalona, Spain. The trial will specifically assess VR's impact on declarative memory and executive functions through interactive exercises, as well as attention and episodic memory through VR video stimuli.

The main questions it aims to answer are:

* Will patients with mild cognitive impairment find the VR program enjoyable and easy to use?
* Can VR interventions help improve patients' cognitive functions, specifically attention and memory?
* Do healthcare professionals find VR a practical tool for cognitive stimulation in their clinical practice?

Participants will undergo a series of 8 sessions, scheduled twice a week to coincide with the conventional rehabilitation appointments. The VR equipment used will be Oculus Quest 2 headsets, offering an immersive experience with hand-tracking technology that simplifies interactions, particularly beneficial for those with mild cognitive impairment (MCI). During the study, participants will:

* Engage with a VR-based cognitive stimulation program.
* Undergo assessments of the participants´ cognitive functions before and after the intervention.
* Provide feedback on the participants´ experience with the VR program.

Researchers will analyze the data to see if:

* The VR program leads to noticeable improvements in the cognitive abilities of participants.
* The program is well-received and deemed beneficial by both patients and healthcare professionals.

Detailed description: Background:

Cognitive impairment affects a significant portion of the aging population, leading to challenges in daily functioning and a reduced quality of life. Traditional cognitive rehabilitation techniques have shown benefits, but patient engagement and adherence remain challenging. Innovations such as virtual reality (VR) offer new avenues for cognitive stimulation, potentially enhancing patient involvement and treatment outcomes.

Study Design:

This clinical trial aims to evaluate the acceptability and efficacy of a VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment at Centro Sociosanitario El Carme in Badalona. It will employ a pretest-posttest design to assess cognitive changes, utilizing standardized cognitive scales and gathering qualitative feedback on user experience.

Objectives:

Primary Objective: To assess the acceptability of the VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment.

Secondary Objectives:

To evaluate whether the VR interventions are perceived as engaging and motivating by the patients, which would suggest positive adherence to the cognitive stimulation program.

To measure changes in cognitive performance, particularly in attention and memory, pre- and post-intervention, to determine the effectiveness of the program.

To understand healthcare professionals' perceptions of the applicability of VR interventions in clinical practice for cognitive stimulation.

To identify potential improvements for the implementation of the VR program based on patient and healthcare staff feedback.

To gather data that could be useful for the development of future VR experiences aimed at patients with cognitive impairments.

Methodology:

Participants will be recruited from the Centro Sociosanitario El Carme and will undergo an initial assessment to establish a cognitive baseline. The participants will then engage in a series of VR sessions designed to provide cognitive stimulation. The program will focus on exercises to enhance attention and memory, incorporating interactive elements to maintain engagement. After completing the sessions, participants will be re-assessed using the same cognitive scales.

Feedback on the VR experience will be collected through structured interviews and questionnaires to gauge acceptability, perceived usefulness, and motivation. Healthcare professionals involved in the administration of the VR program will also be interviewed to understand their views on the integration of VR into therapeutic practices.

Expected Outcomes:

It is hypothesized that the VR program will be well-received by patients, evidenced by high rates of program completion and positive subjective feedback. Post-intervention improvements in cognitive scale scores are expected, indicating the potential efficacy of VR-based stimulation. Insights from healthcare professionals are anticipated to highlight the practicality of VR in clinical settings and suggest improvements for future applications.

Relevance:

The findings from this trial could support the adoption of VR technologies in cognitive rehabilitation, offering a novel, scalable, and potentially more effective approach to managing cognitive impairments. The study may also contribute to the evidence base required for integrating technological innovations into standard healthcare practice.

Conclusion:

By exploring the intersection of VR technology and cognitive rehabilitation, this study seeks to advance the understanding of innovative treatments for cognitive impairments and foster improved patient outcomes through enhanced engagement and stimulation.

Eligibility criteria: Inclusion Criteria:

* Participants must be classified as having mild cognitive impairment with a Mini-Mental State Examination (MMSE) score greater than 23.
* Participants must be currently attending cognitive rehabilitation sessions at the Day Hospital of the Centro Sociosanitario El Carme (CSSC).
* Participants must be able to give informed consent or, in the case of incapacity, consent must be obtained from their legal representative.

Exclusion Criteria:

* Patients with a severe or unstable illness that could interfere with participation in the study.
* Patients with serious psychiatric disorders, such as psychotic disorders, delusions, or hallucinations that may be exacerbated by the use of virtual reality.
* Patients with severe visual limitations that would prevent the use of virtual reality.
* Presence of ocular diseases causing blurred vision that cannot be corrected with contact lenses or glasses.
* Presence of auditory pathologies that cause a significant decrease in hearing without hearing aids.
* High sensitivity to motion sickness.
* Subjects with epilepsy.
* Patients who are unable or unwilling to give informed consent.

Withdrawal Criteria

The emergence of health problems that could interfere with the continuity of participation in the study, or the withdrawal of consent by the participant.

Primary outcomes:
measure: Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS)
timeFrame: immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8)
measure: Comfort of VR Headset as Measured by an 8-Item SUS:
timeFrame: immediately post-intervention, within 30 minutes after the 8th session (day 8)
Secondary outcomes:
measure: Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS:
timeFrame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
measure: VR Headset Comfort Rating for Professionals as Measured by an Adapted 3-Item SUS:
timeFrame: immediately post-intervention, within 30 minutes after the 8th session (day 8)
measure: Global Cognition as Measured by the Mini-Mental State Examination (MMSE)
timeFrame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
measure: Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
measure: Short-Term Memory as Measured by the Digit Span Test (DST Forward Span)
timeFrame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
measure: Working Memory as Measured by the Digit Span Test (DST Backward Span)
timeFrame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
measure: Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A)
timeFrame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
measure: Executive Function as Measured by the Trail Making Test Part B (TMT-B)
timeFrame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
measure: Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Other outcomes:
measure: Demographics Variables
timeFrame: Baseline
measure: Demographics Variables
timeFrame: Baseline
Locations:
city: Badalona
country: Spain
facility: Centro Socio Sanitario El Carmen
state: Barcelona
Study officials:
affiliation: Medical Researcher and Project Manager
name: Jose Ferrer Costa, MD
role: PRINCIPAL_INVESTIGATOR
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