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

Primary Purpose

Dementia, Caregiver Burden

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The virtual reality educational modules
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Over 20 years; Speak Chinese; Take care of people with dementia currently. 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; The individual with dementia is currently residing in a care facility.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Dementia VR education

    Traditional dementia education (lecture)

    Arm Description

    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.

    The control group will receive traditional education on dementia which is primarily taught by instructors.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    September 27, 2023
    Last Updated
    October 19, 2023
    Sponsor
    Taipei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06072274
    Brief Title
    Efficacy of VR Educational Program on Empathy and Attitudes Toward Dementia in Caregivers
    Official Title
    Efficacy of Virtual Reality Educational Program on Empathy and Attitudes Toward Dementia in Caregivers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 14, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia, Caregiver Burden

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dementia VR education
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Traditional dementia education (lecture)
    Arm Type
    No Intervention
    Arm Description
    The control group will receive traditional education on dementia which is primarily taught by instructors.
    Intervention Type
    Other
    Intervention Name(s)
    The virtual reality educational modules
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Empathy, measured by Jefferson Scale of Empathy
    Description
    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.
    Time Frame
    Immediate post-test
    Title
    Change in Empathy, measured by Jefferson Scale of Empathy at 1 month
    Description
    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.
    Time Frame
    1 month follow-up
    Title
    Attitude, measured by Approach to Dementia Questionnaire
    Description
    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.
    Time Frame
    Immediate post-test
    Title
    Change in Attitude, measured by Approach to Dementia Questionnaire at 1 month
    Description
    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 follow-up
    Secondary Outcome Measure Information:
    Title
    Change in Caregivers' burden, measuredn by Zarit Burden Interview
    Description
    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
    1 month follow-up
    Title
    Caregivers' mental health status, measured by Brief Symptom Rating Scale-5
    Description
    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
    1 month follow-up
    Title
    User experience interview of the VR education program on dementia
    Description
    We would also collect user experience data from participants after the VR education program on dementia.
    Time Frame
    Immediate after the program

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Over 20 years; Speak Chinese; Take care of people with dementia currently. 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; The individual with dementia is currently residing in a care facility.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dorothy Bai, PhD
    Phone
    +886-2-27361661
    Ext
    6332
    Email
    dbai@tmu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dorothy Bai, PhD
    Organizational Affiliation
    Taipei Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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