NCT06072274

Brief Summary

This randomized controlled trial evaluated a single-session virtual reality (VR) dementia simulation with guided small-group reflection compared with a time-matched, instructor-led lecture. A total of 227 caregivers of people with a formal diagnosis of dementia were enrolled and randomized. Empathy and attitudes toward dementia were assessed at baseline, immediately after the session, and 1 month after the session. Caregiver burden and psychological distress were assessed at baseline and 1 month after the session.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

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

First Submitted

Initial submission to the registry

September 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 9, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2024

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

September 27, 2023

Last Update Submit

January 11, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in empathy, measured by Jefferson Scale of Empathy

    Empathy is one of the major outcomes which we expect to be improved after the VR education program on dementia. The Jefferson Scale of Empathy (JSE): This scale is used to assess the empathy in caregivers. It is rated on a Likert seven-point scale, with 1 indicating strongly disagree and 7 indicating strongly agree. The scale consists of 20 items and is divided into three major dimensions: perspective taking, compassionate care, and standing in the patient's shoes. The total score ranges from 20 to 140, with higher scores indicating a more positive level of empathy.

    Immediate post-session

  • Change in empathy, measured by Jefferson Scale of Empathy at 1 month

    Empathy is one of the major outcomes which we expect to be improved after the VR education program on dementia. The Jefferson Scale of Empathy (JSE): This scale is used to assess the empathy in caregivers. It is rated on a Likert seven-point scale, with 1 indicating strongly disagree and 7 indicating strongly agree. The scale consists of 20 items and is divided into three major dimensions: perspective taking, compassionate care, and standing in the patient's shoes. The total score ranges from 20 to 140, with higher scores indicating a more positive level of empathy.

    1 month post-session

  • Change in attitude, measured by Approach to Dementia Questionnaire

    Approach is one of the major outcomes which we expect to be improved after the VR education program on dementia. The Approach to Dementia Questionnaire (ADQ) is used to assess attitudes toward dementia care. The questionnaire consists of two dimensions: hope and person-centeredness, with a total of 19 items. It is rated on a Likert five-point scale, with 1 indicating strongly disagree and 5 indicating strongly agree. The total score ranges from 19 to 95, with higher scores indicating a more positive attitude of caregivers toward dementia care.

    Immediate post-session

  • Change in attitude, measured by Approach to Dementia Questionnaire at 1 month

    Approach is one of the major outcomes which we expect to be improved after the VR education program on dementia. The Approach to Dementia Questionnaire (ADQ) is used to assess attitudes toward dementia care. The questionnaire consists of two dimensions: hope and person-centeredness, with a total of 19 items. It is rated on a Likert five-point scale, with 1 indicating strongly disagree and 5 indicating strongly agree. The total score ranges from 19 to 95, with higher scores indicating a more positive attitude of caregivers toward dementia care.

    1 month post-session

Secondary Outcomes (2)

  • Change in Caregivers' burden, measured by Zarit Burden Interview

    Baseline and 1 month post-session

  • Caregivers' mental health status, measured by Brief Symptom Rating Scale-5

    Baseline and 1 month post-session

Study Arms (2)

Virtual reality dementia simulation with guided reflection

EXPERIMENTAL

A single 3-hour virtual reality (VR) dementia simulation delivered in three consecutive segments, each followed by guided small-group reflection.

Behavioral: Virtual reality dementia simulation with guided reflection

Traditional dementia education (lecture)

ACTIVE COMPARATOR

Traditional dementia education (lecture) of equal duration.

Behavioral: Traditional dementia education (lecture)

Interventions

A single 3-hour VR dementia simulation delivered in three consecutive segments, each followed by guided small-group reflection.

Virtual reality dementia simulation with guided reflection

Instructor-led lecture of equal duration

Traditional dementia education (lecture)

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 20 years;
  • Speak Chinese;
  • Currently providing care to a person with a formal diagnosis of dementia (paid formal caregivers or unpaid family caregivers).

You may not qualify if:

  • Those who are unable to use VR devices due to certain physical or mental situations;
  • Those who have fear/disgust for VR devices;
  • Those who feel dizzy after using VR devices;
  • For family caregivers: the care recipient is currently residing in a care facility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

Related Publications (1)

  • Bai D, Chiu HL, Lin SC, Tan Cheng Kian K, Hsu YL, Lin GH. Enhancing empathy and attitudes toward dementia among formal caregivers through virtual reality: a randomized controlled trial. Innov Aging. 2025 Dec 15;10(4):igaf145. doi: 10.1093/geroni/igaf145. eCollection 2026.

MeSH Terms

Conditions

DementiaCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Dorothy Bai, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 10, 2023

Study Start

December 9, 2023

Primary Completion

March 16, 2024

Study Completion

March 16, 2024

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations