NCT06888986

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. 1.Does the VR-based intervention enhance participants' knowledge related to dementia and their health literacy?
  2. 2.Does the VR-based intervention improve cognitive function, mental well-being, and self-efficacy compared to a control group?
  3. 3.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.
  4. 4.Control group: This group will receive standard, routine health education without VR exposure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

March 11, 2025

Last Update Submit

February 18, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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

    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)

Study Arms (2)

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).

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.

Interventions

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.

Experimental Group (VR Dementia Prevention Education)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Cognitive DysfunctionDementiaHealth Education

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 21, 2025

Study Start

September 30, 2024

Primary Completion

May 8, 2025

Study Completion

August 10, 2025

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations