Personalized Virtual Environments for Managing Responsive Behaviors in Cognitively Impaired Patients: a Feasibility Study (iEMBRACE)

November 15, 2024 updated by: Susanna Pardini, Fondazione Bruno Kessler

Personalized Virtual Environments for Patients with Cognitive Impairment Exhibiting Responsive Behaviors: Proof-of-Concept and Feasibility Study

The goal of this feasibility study is to explore the feasibility of using realistic, customizable virtual reality (VR) environments in response to the onset of Responsive Behaviors in elderly residents with cognitive impairment.

Specifically, the study will assess;

  • feasibility through acceptance metrics (including recruitment rate, adherence rate, attrition rate, and tolerance to the intervention);
  • safety (monitoring for adverse effects related to VR headset use);
  • user engagement, enjoyment, and overall experience.

Participants will be exposed to three VR sessions conducted before, during, or after a situation deemed activating (e.g., personal hygiene activities). Operators will conduct a baseline assessment to identify specific moments when the participant experiences responsive behaviors. Additionally, operators may administer the Oculus VR headset when responsive behaviors occur outside of baseline-identified moments.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Site and Environment: Data collection will occur at the Azienda Pubblica di Servizi alla Persona "Margherita Grazioli" in Povo, Trento. The experimental setup will be free from external interference to minimize distractions and ensure a smooth study process. The study will be conducted in familiar, ecologically relevant settings within APSP, selecting environments likely to stimulate activation states in participants.

Duration and Procedure: The study is expected to last six months. Each participant will undergo at least three VR sessions about situations that may trigger activation, such as personal hygiene activities. A baseline assessment will pinpoint specific times when participants exhibit responsive behaviors. Additionally, VR sessions may be initiated if responsive behaviors arise outside the predicted times using the Oculus headset.

Procedure and Timing for Each VR Session:

Preliminary Assessment (Participant Selection) (~30 minutes):

Participants are selected based on inclusion/exclusion criteria and provided with informed consent.

Information is collected from clinical records and updated based on the participant's condition.

An initial assessment examines responsive behaviors' type, frequency, and timing using demographic information, FAST, NPI, and CMAI.

Pre-Session Evaluation (T0) (~15 minutes):

Assessments include pain, responsive behaviors, emotions, anxiety, pleasantness, and discomfort before VR use (using PAINAD and STAI-Y1).

Virtual Environment Selection (~5 minutes):

The operator selects the VR environment for the participant through a smartphone linked to the Oculus headset via WiFi.

Procedure Explanation and Contextualization (~5 minutes):

A brief overview of the session and VR setup is provided to the participant.

Familiarization with Oculus Headset (~1-2 minutes):

A brief period to help the participant acclimate to the VR headset.

VR Session and During-Session Evaluation (T1) (~8 minutes within tolerance):

The VR session is audio-visual recorded, with the operator noting participant behaviors and responses (using OERS, Observation Sheet, STAI-Y1, Ad Hoc Questionnaire, PAINAD, and DataSheet2).

Post-Session Evaluation (T2) (~15 minutes):

Pain, responsive behaviors, emotions, anxiety, pleasantness, and discomfort are re-evaluated (using PAINAD, DataSheet2, Ad Hoc Questionnaire, STAI-Y1, OERS, NPT-ES, and VRSQ).

Final Evaluation (T3) (~10 minutes):

After all sessions, a final assessment using the Cohen-Mansfield Agitation Inventory (CMAI) is conducted.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Susanna Pardini
  • Phone Number: +39 0461314154
  • Email: spardini@fbk.eu

Study Contact Backup

Study Locations

  • Italy
      • Trento, Italy, 38123
        • APSP ''Grazioli''
        • Contact:
        • Contact:
          • Susanna Pardini
        • Contact:
          • Marco Dianti
        • Contact:
          • Oscar Mayora
        • Contact:
          • Lorenzo Gios
        • Contact:
          • Stefano Forti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults over 18 years of age.
  • Native Italian speakers.
  • Can provide written informed consent for study participation or have a legal guardian who can give consent on their behalf.

Exclusion Criteria:

  • Presence of any psychiatric diagnoses as recorded in medical records.
  • A total score of ≥ 40 on the Neuropsychiatric Inventory (NPI) indicates neuropsychiatric symptoms.
  • A partial NPI score > 6 in the domains of agitation/aggression or delusions.
  • Enrollment in palliative care services.
  • Severe neurological damage, a positive diagnosis of epilepsy, or having first-degree relatives diagnosed with epilepsy.
  • Presence of a cardiac pacemaker or other metallic devices.
  • Infectious or gastrointestinal disorders.
  • Open facial wounds, motor or visual impairments, or neuromuscular pain that would prevent using the Oculus VR headset.
  • Refusal to consent, either by the individual or their legal representative, for study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality group
Participants will undergo three VR exposure sessions using Oculus headsets, presenting a virtual environment with realistic natural stimuli or customized environments tailored to individual preferences and valued activities. For each environment, auditory (e.g., animal sounds, wind rustling, type of music) and visual elements (e.g., presence of people, objects, or animals), as well as time of day and weather conditions, can be adjusted. The operator will customize the environment through a user-friendly smartphone app interface, enabling real-time parameter adjustments and content selection. During VR exposure, the operator can observe the participant's visual focus in real-time.
Device: Immersive Virtual Reality
Individuals will participate in three VR sessions using Oculus headsets, experiencing virtual environments featuring realistic natural stimuli or custom settings tailored to their preferences and valued activities. Each environment allows for the adjustment of auditory elements (such as animal sounds, rustling wind, or specific music), visual elements (such as people, objects, or animals), and the time of day and weather conditions. The operator will use a user-friendly smartphone app to customize the environment, making real-time adjustments to settings and content. Throughout the VR experience, the operator can monitor the participant's visual focus in real-time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility based on the health staff operator perspective using the System Usability Scale (SUS)
Time Frame: From enrollment to the end of treatment at 3 weeks
The SUS scale permitted the obtaining of information about the system's usability. The SUS range raw score from 0 to 100.
From enrollment to the end of treatment at 3 weeks
Feasibility using an Ad-hoc questionnaire
Time Frame: From enrollment to the end of treatment at 3 weeks
The ad-hoc questionnaire permitted information about usability, engagement, satisfaction, and pleasure during exposure to the VR environment, as well as feelings and relaxation. The questionnaire is composed of 30 items based on a Likert scale from 1 to 5 (range score from 0 to 4), 15 items based on a Likert scale from 1 to 4 (range score from 0 to 3), and five open-ended questions.
From enrollment to the end of treatment at 3 weeks
Feasibility using the Non-pharmacological Therapy Experience Scale (NPT-ES)
Time Frame: From enrollment to the end of treatment at 3 weeks
The NPT-ES permitted obtaining information about the subjective experience during the administration of non-pharmacological therapy. Five items are assessed on a Likert scale from 0 to 3. The total raw score is from 0 to 15.
From enrollment to the end of treatment at 3 weeks
Feasibility based on the health staff operator perspective using Focus Groups
Time Frame: From enrollment to the end of treatment at 3 weeks
From enrollment to the end of treatment at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the Responsive Behaviors administering the COHEN MANSFIELD - AGITATION INVENTORY (CMAI)
Time Frame: From enrollment to the end of treatment at 3 weeks
The CMAI was permitted to obtain information about the frequencies of 29 different responsive behaviors based on a Likert scale from 0 to 6. The total raw score is from 0 to 174.
From enrollment to the end of treatment at 3 weeks
Assessment of the Responsive Behaviors administering the Functional Assessment Staging Tool (FAST)
Time Frame: From enrollment to the end of treatment at 3 weeks
The FAST is a scale that permits the definition of the severity of functional impairment related to a diagnosis of cognitive impairment. It comprises seven degrees of severity and is assessed by the clinical health staff based on the anamnestic information.
From enrollment to the end of treatment at 3 weeks
Investigation of Adverse Symptoms Associated with Exposure to the Virtual Reality Device using the Virtual Reality Symptoms Questionnaire (VRSQ)
Time Frame: From enrollment to the end of treatment at 3 weeks
The VRSQ assesses the general and eye-related physical symptoms of exposure to a virtual reality environment. The score assigned to each item ranges from 0 to 6, with a maximum total score of 84 (48 for general symptoms and 36 for eye symptoms). Higher scores represent worse symptoms, with 0 corresponding to no adverse effects and 84 to serious adverse effects.
From enrollment to the end of treatment at 3 weeks
Pain experience assessment using the Pain Assessment in Advanced Dementia (PAINAD)
Time Frame: From enrollment to the end of treatment at 3 weeks
The PAINAD provides a method of analyzing the pain experienced by people with dementia. The total score ranges from 0-10 points.
From enrollment to the end of treatment at 3 weeks
Assessment of the pharmacotherapy administration and the users'behaviors before or during the VR sessions using the DataSheet 2
Time Frame: From enrollment to the end of treatment at 3 weeks
DataSheet 2 permits obtaining information about the administration of pharmacotherapy before, during, or after the VR exposure based on three open-ended questions filled out by the health staff operator that administers the experimental procedure. Moreover, the scale permitted information about the user's behavior during the VR exposure to be assessed by the health staff operator based on five questions on a Likert scale from 0 to 3 (Total raw score from 0 to 15).
From enrollment to the end of treatment at 3 weeks
Assessment of the state-anxiety using the State-Trait Anxiety Inventory-Y1 (STAI-Y1)
Time Frame: From enrollment to the end of treatment at 3 weeks
The modified version of the (STAI-Y1), inspired by Appel et al.2021, was administered in this study to obtain information on the state-anxiety level and other types of emotions individuals experienced before and after the VR session. The current study will investigate relaxation, worry/anxiety, sadness, tightness, annoyance, and anger explicitly. The scale is administered as an interview based on a 5-point Likert scale from 1 (not at all) to 5 (a lot).
From enrollment to the end of treatment at 3 weeks
Emotional and behavioral assessment using the Observed Emotion Rating Scale (OERS)
Time Frame: From enrollment to the end of treatment at 3 weeks
The OERS assess the presence and frequency of negative emotions (fear, anxiety, anger, and sadness) and positive (pleasure) feelings experienced during the session based on a scale from 1 to 5 (1: "undetected emotion"; 2: "emotion observed for less than 16 s"; 3: "emotion observed for 16-59 s"; 4: "emotion observed for 1-5 min"; 5: "emotion observed for more than 5 min").
From enrollment to the end of treatment at 3 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Assessment of Socio-demographic features using the Socio-demographic sheet
Time Frame: From enrollment to the end of treatment at 3 weeks
From enrollment to the end of treatment at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Bruno Kessler

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Estimated)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VR2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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