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Completed

NCT Number: NCT06072274

Efficacy of VR 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.

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Key information

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality dementia simulation with guided reflection

Behavioral

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

Traditional dementia education (lecture)

Behavioral

Instructor-led lecture of equal duration

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Efficacy of Virtual Reality Educational Program on Empathy and Attitudes Toward Dementia in Caregivers

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2023
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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