- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06072274
Efficacy of VR Educational Program on Empathy and Attitudes Toward Dementia in Caregivers
January 11, 2026 updated by: Taipei Medical University
Efficacy of Virtual Reality Educational Program on Empathy and Attitudes Toward Dementia in Caregivers
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.
Study Overview
Status
Completed
Conditions
Detailed Description
This study used a parallel, two-arm randomized controlled design to evaluate a VR-based dementia simulation for caregiver education.
A total of 227 caregivers of people with a formal diagnosis of dementia were enrolled and randomized to either (1) a single 3-hour VR dementia simulation delivered in three consecutive segments, each followed by guided small-group reflection (intervention), or (2) an instructor-led dementia education lecture of equal duration (control).
Empathy and attitudes toward dementia were assessed at baseline, immediately post-session, and 1 month post-session.
Caregiver burden and psychological distress were assessed at baseline and 1 month post-session.
Study Type
Interventional
Enrollment (Actual)
227
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan
- Taipei Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Over 20 years;
- Speak Chinese;
- Currently providing care to a person with a formal diagnosis of dementia (paid formal caregivers or unpaid family caregivers).
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality dementia simulation with guided reflection
A single 3-hour virtual reality (VR) dementia simulation delivered in three consecutive segments, each followed by guided small-group reflection.
|
A single 3-hour VR dementia simulation delivered in three consecutive segments, each followed by guided small-group reflection.
|
|
Active Comparator: Traditional dementia education (lecture)
Traditional dementia education (lecture) of equal duration.
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Instructor-led lecture of equal duration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in empathy, measured by Jefferson Scale of Empathy
Time Frame: Immediate post-session
|
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
Time Frame: 1 month post-session
|
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.
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1 month post-session
|
|
Change in attitude, measured by Approach to Dementia Questionnaire
Time Frame: Immediate post-session
|
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.
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Immediate post-session
|
|
Change in attitude, measured by Approach to Dementia Questionnaire at 1 month
Time Frame: 1 month post-session
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Caregivers' burden, measured by Zarit Burden Interview
Time Frame: Baseline and 1 month post-session
|
We also expect that caregivers' burden would be reduced after the VR education program on dementia.
Zarit Burden Inventory (ZBI): Developed by Zarit et al. in 1980, this inventory is used to measure negative emotions and perceived stress experienced by caregivers in the caregiving process.
The ZBI consists of 22 items, and each item is rated on a scale of 0 to 4 based on the frequency of occurrence, ranging from "never" to "routinely."
The total score ranges from 0 to 88, with higher scores indicating a greater caregiver burden.
Scores between 0 and 20 indicate no or minimal burden, scores between 21 and 40 indicate mild to moderate burden, scores between 41 and 60 indicate moderate to severe burden, and scores between 61 and 88 indicate severe burden.
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Baseline and 1 month post-session
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Caregivers' mental health status, measured by Brief Symptom Rating Scale-5
Time Frame: Baseline and 1 month post-session
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We also expect that caregivers' mental health status would be improved after the VR education program on dementia.
The BSRS-5 is a concise self-administered questionnaire adapted from the 50-item brief symptom rating scale.
It assesses anxiety, depression, hostility, interpersonal sensitivity, and other symptoms, with scores for each item ranging from 0 to 4. A total BSRS-5 score exceeding 14 or a score of 1 or more on the suicide survey item may signal a severe mood disorder.
Scores between 10 and 14 suggest moderate mood disorders, while scores between 6 and 9 may indicate mild mood disorders.
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Baseline and 1 month post-session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dorothy Bai, PhD, Taipei Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2023
Primary Completion (Actual)
March 16, 2024
Study Completion (Actual)
March 16, 2024
Study Registration Dates
First Submitted
September 27, 2023
First Submitted That Met QC Criteria
October 2, 2023
First Posted (Actual)
October 10, 2023
Study Record Updates
Last Update Posted (Actual)
January 13, 2026
Last Update Submitted That Met QC Criteria
January 11, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202308052
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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