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Completed

NCT Number: NCT06888986

Integration of VR and AR Dementia Prevention Health Education Progrom for Older Adults With Mild Cognitive Impairment

The goal of this randomized controlled trial is to evaluate the effectiveness of Virtual Reality (VR)-based cognitive health education for older adults with mild cognitive impairment (MCI) in Taiwan. The study aims to assess whether VR-supported interventions improve cognitive health knowledge, health literacy, and self-management skills among participants.

The primary research questions are:

1. Does the VR-based intervention enhance participants' knowledge related to dementia and their health literacy? 2. Does the VR-based intervention improve cognitive function, mental well-being, and self-efficacy compared to a control group?

Participants will be randomly assigned to one of two groups:

1. Intervention group: This group will receive the "VR Dementia Prevention Health Education Module," an immersive virtual reality program designed to enhance dementia-related knowledge and coping strategies. 2. Control group: This group will receive standard, routine health education without VR exposure.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Adherence Interventions Attitude to Health Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Health Behavior Health Education Health Literacy Medication Adherence Mental Disorders Nervous System Diseases Neurocognitive Disorders Older Adults (65 Years and Older) Patient Acceptance of Health Care Patient Compliance Self-Efficacy Treatment Adherence and Compliance Virtual Reality eHealth

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan Normal University

Taipei, Taiwan

About this study

This study is a randomized controlled trial (RCT) aimed at evaluating the effectiveness of a Virtual Reality (VR)-based cognitive health education program for older adults in Taiwan who show signs of mild cognitive impairment (MCI). The research seeks to determine whether VR-enhanced dementia prevention education increases dementia-related knowledge, health literacy, self-efficacy, and acceptance of dementia compared to a control group receiving standard health education without VR exposure and intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 65 years and older.
  • AD-8 score of 2 or higher, indicating possible cognitive impairment.
  • Ability to understand and follow basic instructions in Mandarin or Taiwanese.
  • Capacity to provide informed consent or have a legally authorized representative to provide consent.
  • Ability to tolerate and interact with VR equipment (e.g., wearing a VR headset, using hand controllers).

Exclusion criteria

  • Diagnosed with moderate to severe dementia (i.e., unable to follow basic instructions).
  • Presence of severe visual, auditory, or motor impairments that hinder interaction with VR devices.
  • Diagnosed with severe psychiatric disorders (e.g., schizophrenia, major depressive disorder).
  • Unable to communicate effectively in Mandarin or Taiwanese.

Treatment and study plan

VR Dementia Prevention Health Education Module

Behavioral

A virtual reality (VR) cognitive health education program designed to enhance knowledge related to dementia, improve health literacy, boost self-efficacy, and shape attitudes towards dementia. Participants engage with 360-degree immersive VR modules using VR headsets that simulate real-world scenarios related to dementia. The intervention comprises five interactive VR sessions, each addressing important topics in dementia prevention and management. Trained research staff will guide participants to ensure safe and effective interaction with the VR system.

Primary outcomes

  1. Change in Dementia-Related Knowledge

    Time frame: Baseline (Day 0, prior to intervention start) Immediate Post-Intervention (Day 0, following completion of the VR session, approximately 2 hours after Baseline assessment) Follow-up (Month 3, 12 weeks post-intervention, to assess retention effects)

    Dementia-related knowledge will be assessed using the Dementia Knowledge Assessment Scale (DKAS), a validated tool for evaluating comprehensive understanding of dementia. The DKAS includes 25 true/false items and provides an additional "Don't Know" response option to reduce guessing.

  2. Change in Health Literacy

    Time frame: Baseline (Day 0, prior to intervention start) Immediate Post-Intervention (Day 0, following completion of the VR session, approximately 2 hours after Baseline assessment) Follow-up (Month 3, 12 weeks post-intervention, to assess retention effects)

    Health literacy concerning dementia prevention will be evaluated using the Dementia Health Literacy Scale (DHLS). The DHLS includes 20 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). This scale features three subdomains: Functional Health Literacy (8 items) - Evaluates the ability to manage dementia-related information for daily needs; Communicative Health Literacy (5 items) - Assesses skills in accessing, understanding, and applying dementia-related health information during interactions; and Critical Health Literacy (7 items) - Gauges higher-order cognitive skills and the ability to critically analyze dementia-related health information.

Secondary outcomes

  1. Change in Self-Efficacy Related to Dementia Prevention

    Time frame: Baseline (Day 0, prior to intervention start) Immediate Post-Intervention (Day 0, following completion of the VR session, approximately 2 hours after Baseline assessment) Follow-up (Month 3, 12 weeks post-intervention, to assess retention effects)

    Self-efficacy will be assessed using the Dementia-Related Self-Efficacy Scale (DSES), which has been adapted from existing self-efficacy measures and validated through expert review and pilot testing. The scale comprises 6 items, rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree).

  2. Change in Attitudes Toward Dementia

    Time frame: Baseline (Day 0, prior to intervention start) Immediate Post-Intervention (Day 0, following completion of the VR session, approximately 2 hours after Baseline assessment) Follow-up (Month 3, 12 weeks post-intervention, to assess retention effects)

    Attitudes toward dementia will be evaluated using the Dementia Attitude Scale (DAS), which has been adapted from the Attitudes Toward Dementia Scale (ATDS) and refined through expert review and pilot testing.

    The scale is made up of 10 items rated on a 5-point Likert scale, where 1 means "strongly disagree" and 5 means "strongly agree."

Sponsors and collaborators

Lead sponsor

National Taiwan Normal University

Other

Registry information

Official study title

Integration of VR, AR, AI and Wearable Technology to Develop Innovative Health Education and Monitoring Systems on Symptom Management, Situational Reaction, Learinging Process and Physical and Psychological Health of Early Dementia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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