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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06072274
Other study ID # N202308052
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 14, 2023
Est. completion date December 31, 2024

Study information

Verified date September 2023
Source Taipei Medical University
Contact Dorothy Bai, PhD
Phone +886-2-27361661
Email dbai@tmu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the effect of VR educational program on improving attitude and empathy toward dementia among caregivers. We plan to recruit around 600 participants and randomly assign them to either a control group or an experimental group. The experimental group will participate in a dementia educational program combining VR lasting approximately 2-3 hours. Data would be collected from related questionnaires to investigate whether combining VR with dementia education can effectively improve participants' empathy and attitude toward dementia.


Description:

This study aims to evaluate the effect of VR educational program on improving attitude and empathy toward dementia among caregivers. We plan to recruit around 600 participants and randomly assign them to either a control group or an experimental group. The control group will receive traditional education on dementia which is primarily taught by instructors. The experimental group will participate in a dementia educational program combining VR lasting approximately 2-3 hours. The virtual reality educational modules predominantly offer first-person narratives that delineate various symptoms associated with dementia. Before, immediately after, and 4 weeks after the traditional and VR educational program, all participants will be asked to complete questionnaires about dementia empathy and attitude to explore whether combining VR with dementia education can effectively improve participants' empathy and attitude toward dementia.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 100 Years
Eligibility Inclusion Criteria: 1. Over 20 years; 2. Speak Chinese; 3. Take care of people with dementia currently. 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. The individual with dementia is currently residing in a care facility.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
The virtual reality educational modules
The experimental group will participate in a dementia education program combining VR lasting approximately 2-3 hours. The virtual reality educational modules predominantly offer first-person narratives that delineate various symptoms associated with dementia.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 of healthcare professionals. 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-test
Primary 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 of healthcare professionals. 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 follow-up
Primary 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) 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-test
Primary 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. 1 month follow-up
Secondary Change in Caregivers' burden, measuredn 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. 1 month follow-up
Secondary 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. 1 month follow-up
Secondary User experience interview of the VR education program on dementia We would also collect user experience data from participants after the VR education program on dementia. Immediate after the program
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