Clinical trial NCT06888986: Integration of VR and AR Dementia Prevention Health Education Progrom for Older Adults With Mild Cognitive Impairment
Official 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Dementia
Health Literacy
Self-Efficacy
Attitude to Health
Virtual Reality
Health Education
eHealth
Older Adults (65 Years and Older)
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Dementia-Related Knowledge
timeFrame: 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)
measure: Change in Health Literacy
timeFrame: 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)
Secondary outcomes:
measure: Change in Self-Efficacy Related to Dementia Prevention
timeFrame: 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)
measure: Change in Attitudes Toward Dementia
timeFrame: 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)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Normal University
Study officials:
References: