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Набор по приглашению NCT07238439

Scenario-Driven Virtual Reality Game for Dementia Education Program

Без фазы С лечением Dementia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: VR-Experienced + ASA VR Group, VR-Experienced + Standard Control Group, VR-Unexposed + ASA VR Group, VR-Unexposed + Standard Control Group.
Кому может быть актуально
Состояния в реестре: Dementia. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индонезия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Scenario-Driven Virtual Reality Game for Dementia Education Among Healthcare Students: Protocol for a Four-Arm Study

Обзор

•Terminology Clarification: In the previous study (NCT06629844), the term ' virtual reality (VR)' referred to a 360-degree video viewed through a VR headset. This format offered an immersive experience but was non-interactive. In contrast, the current study uses an 'ASA VR' intervention, which is a scenario-driven, interactive virtual reality simulation. Participants take part in role-playing with an artificial intelligence (AI) character representing a person living with dementia. This distinction is crucial for understanding the study design and results, as the cognitive and experiential demands of the two formats differ greatly. •Brief Summary: This nested 2x2 factorial quasi-experimental design study focuses on Indonesian nursing students and aims to examine the effectiveness of scenario-driven virtual reality (VR) dementia educational programs. The study uses a four-arm design to evaluate different combinations of interventions. The study addresses the following research questions: What is the effect of a Scenario-Driven VR dementia education program on improving participants' attitude, knowledge, intention to help people living with dementia, ageist attitudes, and participant satisfaction with the Scenario-Driven VR dementia education program? Participants will voluntarily join a 30-minute class education program, with each participant attending only once. The program, integrated into the faculty's dementia-related courses, will be structured around a series of components, including an introduction, Scenario-Driven VR, a post-program questionnaire, and a conclusion.

Подробное описание

•Detailed Description:

1. Research Implementation

1. ASA Program Overview ASA VR is a scenario-driven, interactive virtual reality (VR) learning experience designed to cultivate dementia-competent attitudes and behaviors among healthcare students. Unlike the passive 360° video used in the prior study, ASA requires learners to make decisions, engage in role-play with an AI character portraying a person living with dementia (PLWD), and receive immediate, context-specific feedback. 2. Educational Concept and Design Rationale ASA operationalizes evidence-informed instructional principles: (1) problem-centered, authentic tasks with demonstration and guided practice; (2) anchored, scenario-based learning to encourage transfer; and (3) first-person immersive perspective-taking shown to strengthen empathy in healthcare education using VR. Together, these elements aim to move learners beyond recognition-level knowledge to a situated judgment and prosocial intention. 2. Research Method This study is randomized with parallel assignment. study aims to evaluate scenario-driven VR dementia education programs among nursing students in Indonesia. The participants will be nursing students who are enrolled in specific semesters and courses designated for the implementation of this educational program. The study will be conducted with students in the sixth semester (third year). Participants in this study were drawn from the previous study (NCT06629844). The previous study was a quasi-experimental, two-arm design, consisting of an intervention group that received an education program using VR and a control group that attended conventional classes. In the previous study, we collected questionnaires at three time points: pre-questionnaire (T1), post-questionnaire (T2), and a follow-up questionnaire three months later (T3). In this study, we continue our research using the Scenario-Driven VR Dementia Education Program. We will conduct randomized with parallel assignment study with four arms. The intervention group from the previous study, who had prior VR experience, will be divided into two groups: one receiving the Scenario-Driven VR Dementia Education Program and one serving as a control group. Similarly, the control group from the previous study will also be divided into two groups: one receiving the Scenario-Driven VR Dementia Education Program and one serving as a control group. After finishing the Scenario-Driven VR Dementia Education Program, we will give a post-questionnaire (T4).

All prospective participants will be assigned new ID numbers to ensure the confidentiality of their student ID numbers. Each new ID will correspond to the participant's ID number from the previous study, with the addition of a code to classify them into four groups. This approach will allow us to link participant data in the current study with data from the previous study. The randomization will be perform using computer randomization. The protocol has been reviewed and approved by the Ethics Committee of the Faculty of Nursing, Universitas Airlangga. The Scenario-Driven VR dementia education program will not be integrated into a specific class, but will cover themes related to dementia care. Participants will be recruited through class announcements. An overview of the research process will be provided, and detailed instructions regarding the study will be given shortly before it begins. The research team will announce the study approximately one week in advance, and recruitment will be conducted via Google Forms. Students who register will be randomly assigned to four groups. Selected participants will receive their ID numbers along with details about the program's schedule and location through a class announcement three days prior to the intervention.

On the day of the intervention, participants will attend the designated location and sign an attendance sheet using their IDs. The Principal Investigator (PI) will explain the study's stages and emphasize that participants can withdraw at any time without any consequences. Participation in the study will be entirely voluntary, and there will be no coercion. Students who agree to participate in the study will provide informed consent. Those in the program will complete a questionnaire after the intervention. Regarding recruitment, eligible participants will be identified through the previous study's data. Students registered in the selected courses for the 2025/2026 academic year. All eligible students will receive comprehensive information about the study and an invitation to participate. Both the intervention and control groups will complete post-intervention questionnaires.

The intervention group will receive the Scenario-Driven VR Dementia Education Program, while the control group will attend an online class to receive information about the study, provide informed consent, and complete the post-test questionnaire. Both the intervention and control sessions will be conducted once. Students who provide informed consent in the intervention group will attend a classroom lecture to participate in the Scenario-Driven VR Dementia Education Program and then complete a post-lecture survey (T4). The control group will follow the same timeline for completing the survey (T4).

In the previous study, students experienced a non-interactive 360° video via a headset, which likely enhanced presence and baseline attitude but required no active problem-solving. In this follow-up study, we investigate whether ASA's interactivity provides incremental value (in the form of additive or synergistic effects) beyond prior passive immersion. This design allows us to disentangle (A) the main effect of ASA and (B) whether prior 360° exposure primes learners for greater gains when interactivity is introduced.

Вмешательства

  • Другое VR-Experienced + ASA VR Group
    Participants will attend a single 60-minute session consisting of five components: a 5-minute introduction to welcome participants and outline objectives, followed by a 10-minute study briefing in which the PI explains the study aims, participant roles, and emphasizes voluntary participation, confidentiality, and informed consent. The core 30-minute intervention involves a scenario-driven Virtual Reality Dementia Game where participants role-play interactions with an AI avatar simulating a perso
  • Другое VR-Experienced + Standard Control Group
    Participants in these arms will access dementia-related content through the university's existing e-learning platform as part of their regular curriculum. These groups will not receive a special intervention session from this study and will serve as control groups for the ASA VR program. All participant groups will complete the post-intervention (T4) questionnaires at designated times to measure the study's primary and secondary outcomes.
  • Другое VR-Unexposed + ASA VR Group
    Participants will attend a single 60-minute session consisting of five components: a 5-minute introduction to welcome participants and outline objectives, followed by a 10-minute study briefing in which the PI explains the study aims, participant roles, and emphasizes voluntary participation, confidentiality, and informed consent. The core 30-minute intervention involves a scenario-driven Virtual Reality Dementia Game where participants role-play interactions with an AI avatar simulating a perso
  • Другое VR-Unexposed + Standard Control Group
    Participants in these arms will access dementia-related content through the university's existing e-learning platform as part of their regular curriculum. These groups will not receive a special intervention session from this study and will serve as control groups for the ASA VR program. All participant groups will complete the post-intervention (T4) questionnaires at designated times to measure the study's primary and secondary outcomes.

Первичные конечные точки

  • Primary Outcome Measure: Attitudes Toward People with Dementia Scale [Срок оценки: Immediately post-intervention (T4), on the same day, within 0-60 minutes after session end.]
Вторичные конечные точки (4)
  • Knowledge of Dementia [Срок оценки: Immediately post-intervention (T4), on the same day, within 0-60 minutes after session end.]
  • Intention to Help Persons Living with Dementia [Срок оценки: Immediately post-intervention (T4), on the same day, within 0-60 minutes after session end.]
  • Ageist Attitudes Towards Older Adults [Срок оценки: Immediately post-intervention (T4), on the same day, within 0-60 minutes after session end.]
  • User Experience Questionnaire [Срок оценки: Immediately post-intervention (T4), on the same day, within 0-60 minutes after session end.]

Критерии участия

Критерии включения

  • Registered nursing students at Universitas Airlangga in the designated semester and courses (academic year 2025/2026).
  • Provide informed consent.

Критерии исключения

  • Not enrolled in the specified semester/courses.
  • Prior participation in a scenario-driven VR dementia education program similar to ASA VR that could influence outcomes.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Индонезия · 1 центр
  • Universitas Airlangga — Surabaya

Публикации

  • Wu J, Igarashi A, Suzuki H, Matsumoto H, Kugai H, Takaoka M, Yamamoto-Mitani N. Effects of a dementia educational programme using virtual reality on nurses in an acute care hospital: A pre-post comparative study. Int J Older People Nurs. 2024 May;19(3):e12616. doi: 10.1111/opn.12616. PMID 38769648
  • Suzuki H, Igarashi A, Matsumoto H, Kugai H, Takaoka M, Sakka M, Ito K, Hagiwara Y, Yamamoto-Mitani N. A Dementia-Friendly Educational Program Using Virtual Reality for the General Public in Japan: A Randomized Controlled Trial for DRIVE. Gerontologist. 2024 Nov 1;64(11):gnae113. doi: 10.1093/geront/gnae113. PMID 39140623
  • Sari DW, Igarashi A, Takaoka M, Yamahana R, Noguchi-Watanabe M, Teramoto C, Yamamoto-Mitani N. Virtual reality program to develop dementia-friendly communities in Japan. Australas J Ageing. 2020 Sep;39(3):e352-e359. doi: 10.1111/ajag.12797. Epub 2020 Jun 2. PMID 32483931

Идентификаторы

NCT: NCT07238439 · 3759-KEPK

Первоисточники (государственные реестры)

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