- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06888986
Integration of VR and AR Dementia Prevention Health Education Progrom for Older Adults With Mild Cognitive Impairment
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
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:
- Does the VR-based intervention enhance participants' knowledge related to dementia and their health literacy?
- 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:
- 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.
- Control group: This group will receive standard, routine health education without VR exposure.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taipei, Taiwan
- National Taiwan Normal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Group (VR Dementia Prevention Education)
Participants in this arm will take part in the VR Dementia Prevention Health Education Module, an immersive virtual reality (VR) intervention aimed at enhancing dementia-related knowledge, health literacy, self-efficacy, and attitudes toward dementia.
The intervention combines 360-degree panoramic VR technology with interactive educational content to create a realistic and engaging learning experience for older adults with mild cognitive impairment (MCI).
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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.
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No Intervention: Control Group (No Intervention)
Participants in this arm will not receive any active intervention during the study.
They will continue with their usual daily routine, without exposure to VR-based health education or any structured dementia-related educational programs.
This group serves as a comparison to evaluate the effects of the VR Dementia Prevention Health Education Module administered to the experimental group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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.
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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)
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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)
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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.
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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).
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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)
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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)
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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." |
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)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurocognitive Disorders
- Cognition Disorders
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Patient Compliance
- Patient Acceptance of Health Care
- Adherence Interventions
- Medication Adherence
- Cognitive Dysfunction
- Dementia
- Health Education
Other Study ID Numbers
- 202212HM033
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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