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

Not Applicable

• Conditions: Mild Cognitive Impairment (MCI); Dementia; Attitude to Health; Virtual Reality; Health Education; Health Literacy; Self-Efficacy; eHealth; Older Adults (65 Years and Older)

• Registration Number: NCT06888986
• Lead Sponsor: National Taiwan Normal University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-09-30
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-15
• Study First Posted: 2025-03-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Dementia-Related Knowledge	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.
Change in Health Literacy	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 Outcome Measures

Name	Time	Method
Change in Self-Efficacy Related to Dementia Prevention	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).
Change in Attitudes Toward Dementia	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."

Trial Locations

Locations (1)

National Taiwan Normal University; 🇨🇳 Taipei, Taiwan