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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
227

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dorothy Bai, PhD
  • Phone Number: 6332 +886-2-27361661
  • Email: dbai@tmu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Those who are unable to use VR devices due to certain physical or mental situations;
  2. Those who have fear/disgust for VR devices;
  3. Those who feel dizzy after using VR devices;
  4. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Virtual reality dementia simulation with guided 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.
Behavioral: Traditional dementia education (lecture)
Instructor-led lecture of equal duration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Baseline and 1 month post-session
Caregivers' mental health status, measured by Brief Symptom Rating Scale-5
Time Frame: Baseline and 1 month post-session
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.
Baseline and 1 month post-session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings