Clinical trial NCT06693193: Personalized Virtual Environments for Managing Responsive Behaviors in Cognitively Impaired Patients: a Feasibility Study
Official title: Personalized Virtual Environments for Patients with Cognitive Impairment Exhibiting Responsive Behaviors: Proof-of-Concept and Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Dementia
Keywords: Customization
Customized Virtual Reality Scenarios
Cognitive Impairment
Responsive Behaviors
Virtual Reality Therapy
Non pharmacological therapy
Lead sponsor: Fondazione Bruno Kessler
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility based on the health staff operator perspective using the System Usability Scale (SUS)
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Feasibility using an Ad-hoc questionnaire
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Feasibility using the Non-pharmacological Therapy Experience Scale (NPT-ES)
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Feasibility based on the health staff operator perspective using Focus Groups
timeFrame: From enrollment to the end of treatment at 3 weeks
Secondary outcomes:
measure: Assessment of the Responsive Behaviors administering the COHEN MANSFIELD - AGITATION INVENTORY (CMAI)
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Assessment of the Responsive Behaviors administering the Functional Assessment Staging Tool (FAST)
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Investigation of Adverse Symptoms Associated with Exposure to the Virtual Reality Device using the Virtual Reality Symptoms Questionnaire (VRSQ)
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Pain experience assessment using the Pain Assessment in Advanced Dementia (PAINAD)
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Assessment of the pharmacotherapy administration and the users'behaviors before or during the VR sessions using the DataSheet 2
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Assessment of the state-anxiety using the State-Trait Anxiety Inventory-Y1 (STAI-Y1)
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Emotional and behavioral assessment using the Observed Emotion Rating Scale (OERS)
timeFrame: From enrollment to the end of treatment at 3 weeks
Other outcomes:
measure: Assessment of Socio-demographic features using the Socio-demographic sheet
timeFrame: From enrollment to the end of treatment at 3 weeks
Locations:
city: Trento
country: Italy
facility: APSP ''Grazioli''
Study officials:
References: