Clinical trial NCT05265182: ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia
Official title: Developing an Immersive Gamification Technology System (ImGTS) for the Management of Patients With Behavioral and Psychological Symptoms of Dementia (Phase 1 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia Alzheimers
Lead sponsor: Augmented eXperience E-health Laboratory
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: HMD and Semi-Cave
Primary purpose: OTHER

Brief summary: The proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the first phase. The phase 1 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population.

Detailed description: The participants will undergo an intervention using the assigned ImGTS for four sessions (twice a week for two weeks), with a maximum of 45 minutes per session. VR trials are in 10- to 20-minute periods with introduction, orientation, and provisions for rest periods for patient comfort. During the experience, documentation of the patient's reaction and interaction with the ImGTS will be recorded by the researchers. The participants will be staying at the designated laboratory for not more than one hour.

Demographic characteristics Demographic characteristics of the participant (age, sex, educational attainment, marital status, living conditions, hobbies and interests, previous experience with VE applications, existing illnesses, medications) will be collected by the researchers through a questionnaire. Personal data, such as name and contact information, will only be collected to allow the investigators to contact the participants, as needed.

Safety Safety will be ensured by assessing a participant's experience of cybersickness. A cybersickness questionnaire, the Virtual Reality Sickness Questionnaire will be administered after each session. In this self-report questionnaire, nine symptoms will be rated as absent/none, slight, moderate, or severe. These symptoms are general discomfort, fatigue, eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness when the eyes are closed, and vertigo. Answering the questionnaire will take around 10 minutes.

In the event that a participant will experience severe cybersickness, they may opt to discontinue the experience. They will be instructed to remove the HMD or to step out of the Semi-CAVE room to rest and recover from the symptoms. A medical professional will be present to monitor the participant's symptoms and to attend to them for further management. The reason(s) for discontinuing the experience will be documented.

Acceptability The acceptability of the design will be measured using the Place Probe, a sense of place questionnaire. The questionnaire will be administered after each session, and it will collect information on a participant's experience in the VE application, particularly on (a) their general impression of the environment, (b) the key features of the environment, and (c) their feelings of presence. A positive general impression, a memorable environment, and high level of presence will indicate that the VE developed is acceptable. This will take about 10 minutes to complete.

Usability Usability testing will be performed according to the PNS ISO/IEC Metrics. The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction. Additional usability metrics will be identified during the first phase of the study. The metrics will be specifically adjusted to the target participants as well as the contents to be included in the VR system.

Eligibility criteria: Inclusion Criteria:

* Aged 40 to 59 years old
* Montreal Cognitive Assessment-Philippine Version (MoCA-P) score \> 20
* Neuropsychiatric Inventory (NPI) score of 0
* Able to understand Filipino and English

Exclusion Criteria:

* Previously diagnosed with dementia
* Receptive aphasia
* Previously diagnosed with a psychiatric disorder
* Previously diagnosed with seizures or epilepsy
* Significant visual and hearing impairment
* Has a history of motion sickness
* Quadriplegia or paralysis of dominant hand
* Life expectancy of less than a year

Primary outcomes:
measure: The incidence of cybersickness will be assessed using the Virtual Reality Sickness Questionnaire.
timeFrame: Immediately after each intervention, within an hour of completion of the virtual reality game.
measure: The acceptability of the design will be measured using the Place Probe.
timeFrame: Immediately after each intervention, within an hour of completion of the virtual reality game.
measure: The rate of usability will be performed according to the Philippine National Standards ISO/IEC Metrics.
timeFrame: Within an hour of the end of the study.
Secondary outcomes:
Other outcomes:
Locations:
city: City Of Manila
country: Philippines
facility: College of Allied Medical Professions Clinic for Therapy Services
state: National Capital Region
Study officials:
affiliation: University of the Philippines Manila
name: Veeda Michelle M Anlacan, MD
role: PRINCIPAL_INVESTIGATOR
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