An interventional study of Virtual reality dementia simulation with guided reflection and Traditional dementia education (lecture) in Dementia and Caregiver Burden, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Supportive care
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.
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.
2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.
This study's enrollment of 227 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
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Exclusion Criteria:
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) of equal duration.
Behavioral: Traditional dementia education (lecture)
A single 3-hour VR dementia simulation delivered in three consecutive segments, each followed by guided small-group reflection.
Instructor-led lecture of equal duration
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month post-session
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.
Time frame: 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.
Time frame: Baseline and 1 month post-session
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Taipei Medical University