Mild Cognitive Impairment (MCI)NCT06888986
Integration of VR and AR Dementia Prevention Health Education Progrom for Older Adults With Mild Cognitive Impairment
A study testing VR Dementia Prevention Health Education Module in people with Mild Cognitive Impairment (MCI) and Dementia, run by National Taiwan Normal University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Dementia, Health Literacy
- What is being tested?
- VR Dementia Prevention Health Education Module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2024to 10 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment (MCI), Dementia, Health Literacy, Self-Efficacy, Attitude to Health, Virtual Reality
- Being tested
- VR Dementia Prevention Health Education Module
- Medical subject headings
- Cognitive Dysfunction, Dementia, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Dementia Prevention Health Education ModuleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (VR Dementia Prevention Education) | Experimental | 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). Receives: Behavioral: VR Dementia Prevention Health Education Module |
| Control Group (No Intervention) | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dementia-Related Knowledge
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.
Measured: 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)
Change in Health Literacy
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.
Measured: 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 (2)
Change in Self-Efficacy Related to Dementia Prevention
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).
Measured: 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)
Change in Attitudes Toward Dementia
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."
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start30 Sep 2024
- Primary completion8 May 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888986
- Sponsor's protocol ID
- 202212HM033
- Status last verified
- Feb 2026
- First submitted
- 11 Mar 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06888986
- Acronym / sponsor ID
- 202212HM033
- Conditions
- Mild Cognitive Impairment (MCI), Dementia, Health Literacy, Self-Efficacy, Attitude to Health, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (VR Dementia Prevention Education) | Experimental | Behavioral: VR Dementia Prevention Health Education ModuleParticipants 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). |
| Control Group (No Intervention) | 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR Dementia Prevention Health Education ModuleA 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. | Behavioural | Experimental Group (VR Dementia Prevention Education) |
Primary outcome
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.
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.
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Dementia Prevention Health Education Module in people with Mild Cognitive Impairment (MCI) and Dementia, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.