DementiaNCT06072274
Efficacy of VR Educational Program on Empathy and Attitudes Toward Dementia in Caregivers
A study testing Virtual reality dementia simulation with guided reflection and Traditional dementia education (lecture) in people with Dementia and Caregiver Burden, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Caregiver Burden
- What is being tested?
- Virtual reality dementia simulation with guided reflection and Traditional dementia education (lecture)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Dec 2023to 16 Mar 2024
- 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 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 20 years;
- Speak Chinese;
- Currently providing care to a person with a formal diagnosis of dementia (paid formal caregivers or unpaid family caregivers).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia, Caregiver Burden
- Being tested
- Virtual reality dementia simulation with guided reflection, Traditional dementia education (lecture)
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality dementia simulation with guided reflectionBehavioural
A single 3-hour VR dementia simulation delivered in three consecutive segments, each followed by guided small-group reflection.
Traditional dementia education (lecture)Behavioural
Instructor-led lecture of equal duration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual reality dementia simulation with guided reflection |
| Traditional dementia education (lecture) | Active comparator | Traditional dementia education (lecture) of equal duration. Receives: Behavioral: Traditional dementia education (lecture) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month post-session
Secondary outcomes (2)
Change in Caregivers' burden, measured by Zarit Burden Interview
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.
Measured: Baseline and 1 month post-session
Caregivers' mental health status, measured by Brief Symptom Rating Scale-5
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.
Measured: Baseline and 1 month post-session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start9 Dec 2023
- Primary completion16 Mar 2024
- Study completion16 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorothy Bai, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072274
- Sponsor's protocol ID
- N202308052
- Status last verified
- Jan 2026
- First submitted
- 27 Sep 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41873384
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality Educational Program on Empathy and Attitudes Toward Dementia in Caregivers
- ClinicalTrials.gov ID
- NCT06072274
- Acronym / sponsor ID
- N202308052
- Conditions
- Dementia, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 9 Dec 2023 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 16 Mar 2024 (actual)
- First posted
- 10 Oct 2023 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality dementia simulation with guided reflection | Experimental | Behavioral: Virtual reality dementia simulation with guided reflectionA single 3-hour virtual reality (VR) dementia simulation delivered in three consecutive segments, each followed by guided small-group reflection. |
| Traditional dementia education (lecture) | Active comparator | Behavioral: Traditional dementia education (lecture)Traditional dementia education (lecture) of equal duration. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 20 years;
- Speak Chinese;
- Currently providing care to a person with a formal diagnosis of dementia (paid formal caregivers or unpaid family caregivers).
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Virtual reality dementia simulation with guided reflectionA single 3-hour VR dementia simulation delivered in three consecutive segments, each followed by guided small-group reflection. | Behavioural | Virtual reality dementia simulation with guided reflection |
| Traditional dementia education (lecture)Instructor-led lecture of equal duration | Behavioural | Traditional dementia education (lecture) |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Change in Caregivers' burden, measured by Zarit Burden Interview
Time frame: 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
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 13 Jan 2026.
- Derived from this study: PubMed 41873384Bai 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.
Related trials for Dementia
RecruitingPhase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Parkinson's Disease, Dementia
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Active, not recruiting
The PorchLight Project
Memory Loss, Alzheimer Disease
Active, not recruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
RecruitingPhase 2
Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
Stress
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.
Dorothy Bai, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality dementia simulation with guided reflection and Traditional dementia education (lecture) in people with Dementia and Caregiver Burden, run by Taipei Medical 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 3 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 13 Jan 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 empathy, measured by Jefferson Scale of Empathy (time frame: Immediate post-session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06072274, which also lists 1 linked publication.
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 13 Jan 2026; AzTrials last refreshed its copy on 3 Nov 2026.