EmpathyNCT05541575
Exploring the Effectiveness the Attitude, Competence of Care, Empathy Among the Home Care Workers With Dementia People
A study testing VR films in people with Empathy and Attitude, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
This study develop a new virtual reality course for home care workers to experience the view of dementia people with BPSD and the relative feelings. After the intervention, the experimental group would completed the several scales of attitude of care, competence of care and empathy, then the factor analysis and… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Empathy, Attitude, Competence
- What is being tested?
- VR films
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Aug 2021to 30 Jun 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- is currently or has been serving as an in-home caregiver for a community-dwelling patient with dementia;
- aged 20 years and above
- conversant in Mandarin and Taiwanese
- agreed to participate in this study
Who cannot join
- age 19 years and below
- disagreed to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discussion on Virtual Reality Intervention Course: Exploring the Effectiveness of the Attitude of Care
This study develop a new virtual reality course for home care workers to experience the view of dementia people with BPSD and the relative feelings. After the intervention, the experimental group would completed the several scales of attitude of care, competence of care and empathy, then the factor analysis and correlation analysis were measured.
In the first stage, a single group pre and post test study was conducted to extract 10 home caregivers of dementia care from Hondao Senior Citizen's Welfare Foundation. In order to explore the VR course affect the attitude of care, competent of care and empathy towards the dementia people in community, and future career.
In the second stage, this study use quasi experimental design. The experimental group (n=65) and the control group (n=65) each have a pre- and post-test design. The experimental group uses virtual reality courses for intervention experience, while the control group does not have intervention. After the two post-tests are completed, then provide the same immersive 3D VR experience as the experimental group. The measurement tools in this study used the Jefferson Empathy Scale (Chinese Version), The Interpersonal Reactivity Index (Chinese Version), and three self-made scales focus on dementia care attitude scale, the dementia care competency scale and the virtual reality course experience scale.
Read the detailed description
More than 90% of people with mild and moderate level of dementia live at home in the community. The behaviors and psychological symptoms of dementia (BPSD) would be severe by age, and often increases the difficulty and pressure for family caregivers. Also the outcome from the relative studies are limited.
This study develop a new virtual reality course for home care workers to experience the view of dementia people with BPSD and the relative feelings. After the intervention, the experimental group would completed the several scales of attitude of care, competence of care and empathy, then the factor analysis and correlation analysis were measured.
In the first stage, a single group pre and post test study was conducted to extract 10 home caregivers of dementia care from Hondao Senior Citizen's Welfare Foundation. In order to explore the VR course affect the attitude of care, competent of care and empathy towards the dementia people in community, and future career.
In the second stage, this study use quasi experimental design. The experimental group (n=65) and the control group (n=65) each have a pre- and post-test design. The experimental group uses virtual reality courses for intervention experience, while the control group does not have intervention. After the two post-tests are completed, then provide the same immersive 3D VR experience as the experimental group. The measurement tools in this study used three self-made scales focus on dementia care attitude scale, the dementia care competency scale and the virtual reality course experience scale and empathy scale. ANCOVA would be used for the correlation analysis above scales.
Home care workers can use VR as an appropriate interventions, to empathize with the situation, faced and recognize the weakness, frustration and emotional distress of dementia people. Then change the attitude and arise the competency of care, also should be considered for ensure that patients with dementia stay in good care quality.
- Conditions
- Empathy, Attitude, Competence
- Being tested
- VR films
- Keywords
- home caregivers, careers
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR filmsOther
A new virtual reality course for home care workers to experience the view of dementia people with BPSD and the relative feelings.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Experimental: offered 3 films of VR course of BPSD for 30 mins to each participants. Receives: Other: VR films |
| No intervention | No intervention | NO films of VR course of BPSD to any participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Empathy Scale
It contains 9 questions. There is no subscale. The score of range from 1-5.
Measured: Change from Baseline, T1
Dementia care scale
It contains 22 questions. There is 3 subscale. The score of range from 1-5.
Measured: Change from Baseline, T1
Virtual reality course experience scale
It contains 9 questions. There is 3 subscale. The score of range from 1-5.
Measured: Experimental group need to completion 30 mins intervention, then participants fill the questionnaire.
Secondary outcomes (2)
Empathy Scale
It contains 9 questions. There is no subscale. The score of range from 1-5.
Measured: Through study completion, an average of 2 months(T2)
Dementia care scale
It contains 22 questions. There is 3 subscale. The score of range from 1-5.
Measured: Through study completion, an average of 2 months(T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start5 Aug 2021
- Primary completion30 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for EmpathyStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia Jung Hsieh, National Taipei University of Nursing and Health Sciences
- Investigators
- Chia-Jung Hsieh, PhD, Study director, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541575
- Sponsor's protocol ID
- FJU-C109203
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pollock M, Hornabrook RW. The prevalence, natural history and dementia of Parkinson's disease. Brain. 1966 Sep;89(3):429-48. doi: 10.1093/brain/89.3.429. No abstract available.
PubMed 5921126Elliott R, Bohart AC, Watson JC, Greenberg LS. Empathy. Psychotherapy (Chic). 2011 Mar;48(1):43-9. doi: 10.1037/a0022187.
PubMed 21401273Hattink B, Meiland F, van der Roest H, Kevern P, Abiuso F, Bengtsson J, Giuliano A, Duca A, Sanders J, Basnett F, Nugent C, Kingston P, Droes RM. Web-Based STAR E-Learning Course Increases Empathy and Understanding in Dementia Caregivers: Results from a Randomized Controlled Trial in the Netherlands and the United Kingdom. J Med Internet Res. 2015 Oct 30;17(10):e241. doi: 10.2196/jmir.4025.
PubMed 26519106Wijma EM, Veerbeek MA, Prins M, Pot AM, Willemse BM. A virtual reality intervention to improve the understanding and empathy for people with dementia in informal caregivers: results of a pilot study. Aging Ment Health. 2018 Sep;22(9):1115-1123. doi: 10.1080/13607863.2017.1348470. Epub 2017 Jul 10.
PubMed 28691861Dyer E, Swartzlander BJ, Gugliucci MR. Using virtual reality in medical education to teach empathy. J Med Libr Assoc. 2018 Oct;106(4):498-500. doi: 10.5195/jmla.2018.518. Epub 2018 Oct 1.
PubMed 30271295Shin D. Empathy and embodied experience in virtual environment: To what extent can virtual reality stimulate empathy and embodied experience? Comput Hum Behav. 2018;78:64-73. doi:10.1016/j.chb.2017.09.012
Jutten LH, Mark RE, Maria Janssen BWJ, Rietsema J, Droes RM, Sitskoorn MM. Testing the effectivity of the mixed virtual reality training Into D'mentia for informal caregivers of people with dementia: protocol for a longitudinal, quasi-experimental study. BMJ Open. 2017 Aug 21;7(8):e015702. doi: 10.1136/bmjopen-2016-015702.
PubMed 28827242Jutten LH, Mark RE, Sitskoorn MM. Can the Mixed Virtual Reality Simulator Into D'mentia Enhance Empathy and Understanding and Decrease Burden in Informal Dementia Caregivers? Dement Geriatr Cogn Dis Extra. 2018 Dec 6;8(3):453-466. doi: 10.1159/000494660. eCollection 2018 Sep-Dec.
PubMed 30631337Sari DW, Igarashi A, Takaoka M, Yamahana R, Noguchi-Watanabe M, Teramoto C, Yamamoto-Mitani N. Virtual reality program to develop dementia-friendly communities in Japan. Australas J Ageing. 2020 Sep;39(3):e352-e359. doi: 10.1111/ajag.12797. Epub 2020 Jun 2.
PubMed 32483931Kim D. Development and Effect of Virtual Reality Practice Program for Improving Practical Competency of Caregivers Specializing in Dementia. Healthcare (Basel). 2021 Oct 18;9(10):1390. doi: 10.3390/healthcare9101390.
PubMed 34683070
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discussion on Virtual Reality Intervention Course: Exploring the Effectiveness of the Attitude of Care
- ClinicalTrials.gov ID
- NCT05541575
- Acronym / sponsor ID
- FJU-C109203
- Conditions
- Empathy, Attitude, Competence
- Keywords
- home caregivers, careers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 15 Sep 2022 (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 study develop a new virtual reality course for home care workers to experience the view of dementia people with BPSD and the relative feelings. After the intervention, the experimental group would completed the several scales of attitude of care, competence of care and empathy, then the factor analysis and correlation analysis were measured.
In the first stage, a single group pre and post test study was conducted to extract 10 home caregivers of dementia care from Hondao Senior Citizen's Welfare Foundation. In order to explore the VR course affect the attitude of care, competent of care and empathy towards the dementia people in community, and future career.
In the second stage, this study use quasi experimental design. The experimental group (n=65) and the control group (n=65) each have a pre- and post-test design. The experimental group uses virtual reality courses for intervention experience, while the control group does not have intervention. After the two post-tests are completed, then provide the same immersive 3D VR experience as the experimental group. The measurement tools in this study used the Jefferson Empathy Scale (Chinese Version), The Interpersonal Reactivity Index (Chinese Version), and three self-made scales focus on dementia care attitude scale, the dementia care competency scale and the virtual reality course experience scale.
Detailed description
More than 90% of people with mild and moderate level of dementia live at home in the community. The behaviors and psychological symptoms of dementia (BPSD) would be severe by age, and often increases the difficulty and pressure for family caregivers. Also the outcome from the relative studies are limited.
This study develop a new virtual reality course for home care workers to experience the view of dementia people with BPSD and the relative feelings. After the intervention, the experimental group would completed the several scales of attitude of care, competence of care and empathy, then the factor analysis and correlation analysis were measured.
In the first stage, a single group pre and post test study was conducted to extract 10 home caregivers of dementia care from Hondao Senior Citizen's Welfare Foundation. In order to explore the VR course affect the attitude of care, competent of care and empathy towards the dementia people in community, and future career.
In the second stage, this study use quasi experimental design. The experimental group (n=65) and the control group (n=65) each have a pre- and post-test design. The experimental group uses virtual reality courses for intervention experience, while the control group does not have intervention. After the two post-tests are completed, then provide the same immersive 3D VR experience as the experimental group. The measurement tools in this study used three self-made scales focus on dementia care attitude scale, the dementia care competency scale and the virtual reality course experience scale and empathy scale. ANCOVA would be used for the correlation analysis above scales.
Home care workers can use VR as an appropriate interventions, to empathize with the situation, faced and recognize the weakness, frustration and emotional distress of dementia people. Then change the attitude and arise the competency of care, also should be considered for ensure that patients with dementia stay in good care quality.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: VR filmsExperimental: offered 3 films of VR course of BPSD for 30 mins to each participants. |
| No intervention | No intervention | –NO films of VR course of BPSD to any participants. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- is currently or has been serving as an in-home caregiver for a community-dwelling patient with dementia;
- aged 20 years and above
- conversant in Mandarin and Taiwanese
- agreed to participate in this study
Key exclusion criteria (2 listed)
- age 19 years and below
- disagreed to participate in this study.
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 |
|---|---|---|
| VR filmsA new virtual reality course for home care workers to experience the view of dementia people with BPSD and the relative feelings. | Other | Intervention |
Primary outcome
Empathy Scale
Time frame: Change from Baseline, T1
It contains 9 questions. There is no subscale. The score of range from 1-5.
Dementia care scale
Time frame: Change from Baseline, T1
It contains 22 questions. There is 3 subscale. The score of range from 1-5.
Virtual reality course experience scale
Time frame: Experimental group need to completion 30 mins intervention, then participants fill the questionnaire.
It contains 9 questions. There is 3 subscale. The score of range from 1-5.
2 secondary outcomes
Empathy Scale
Time frame: Through study completion, an average of 2 months(T2)
Dementia care scale
Time frame: Through study completion, an average of 2 months(T2)
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 15 Sep 2022.
- Background: PubMed 5921126Pollock M, Hornabrook RW. The prevalence, natural history and dementia of Parkinson's disease. Brain. 1966 Sep;89(3):429-48. doi: 10.1093/brain/89.3.429. No abstract available.
- Background: PubMed 21401273Elliott R, Bohart AC, Watson JC, Greenberg LS. Empathy. Psychotherapy (Chic). 2011 Mar;48(1):43-9. doi: 10.1037/a0022187.
- Background: PubMed 26519106Hattink B, Meiland F, van der Roest H, Kevern P, Abiuso F, Bengtsson J, Giuliano A, Duca A, Sanders J, Basnett F, Nugent C, Kingston P, Droes RM. Web-Based STAR E-Learning Course Increases Empathy and Understanding in Dementia Caregivers: Results from a Randomized Controlled Trial in the Netherlands and the United Kingdom. J Med Internet Res. 2015 Oct 30;17(10):e241. doi: 10.2196/jmir.4025.
- Background: PubMed 28691861Wijma EM, Veerbeek MA, Prins M, Pot AM, Willemse BM. A virtual reality intervention to improve the understanding and empathy for people with dementia in informal caregivers: results of a pilot study. Aging Ment Health. 2018 Sep;22(9):1115-1123. doi: 10.1080/13607863.2017.1348470. Epub 2017 Jul 10.
- Background: PubMed 30271295Dyer E, Swartzlander BJ, Gugliucci MR. Using virtual reality in medical education to teach empathy. J Med Libr Assoc. 2018 Oct;106(4):498-500. doi: 10.5195/jmla.2018.518. Epub 2018 Oct 1.
- BackgroundShin D. Empathy and embodied experience in virtual environment: To what extent can virtual reality stimulate empathy and embodied experience? Comput Hum Behav. 2018;78:64-73. doi:10.1016/j.chb.2017.09.012
- Background: PubMed 28827242Jutten LH, Mark RE, Maria Janssen BWJ, Rietsema J, Droes RM, Sitskoorn MM. Testing the effectivity of the mixed virtual reality training Into D'mentia for informal caregivers of people with dementia: protocol for a longitudinal, quasi-experimental study. BMJ Open. 2017 Aug 21;7(8):e015702. doi: 10.1136/bmjopen-2016-015702.
- Background: PubMed 30631337Jutten LH, Mark RE, Sitskoorn MM. Can the Mixed Virtual Reality Simulator Into D'mentia Enhance Empathy and Understanding and Decrease Burden in Informal Dementia Caregivers? Dement Geriatr Cogn Dis Extra. 2018 Dec 6;8(3):453-466. doi: 10.1159/000494660. eCollection 2018 Sep-Dec.
- Background: PubMed 32483931Sari DW, Igarashi A, Takaoka M, Yamahana R, Noguchi-Watanabe M, Teramoto C, Yamamoto-Mitani N. Virtual reality program to develop dementia-friendly communities in Japan. Australas J Ageing. 2020 Sep;39(3):e352-e359. doi: 10.1111/ajag.12797. Epub 2020 Jun 2.
- Background: PubMed 34683070Kim D. Development and Effect of Virtual Reality Practice Program for Improving Practical Competency of Caregivers Specializing in Dementia. Healthcare (Basel). 2021 Oct 18;9(10):1390. doi: 10.3390/healthcare9101390.
- Individual participant dataSharing planned: No
Related trials for Empathy
Active, not recruiting
AI Ambient Scribe in Psychiatry
Therapeutic Alliance, Empathy
Not yet recruiting
Psychosocial Effects of Empathy-Based Midwifery Education on Midwifery Students and Pregnant Women
Empathy, Anxiety
Not yet recruiting
Development of the '1 Situation-5 Minutes' Game and Evaluation of Its Impact on Care Awareness and Empathy: A Mixed-Methods Study
Nursing Students' Care Awareness and Empathy
Not yet recruiting
The Effect of Creative Drama on the Therapeutic Communication Skills and Empathy Levels of Pediatric Nursing Students: A Randomized Controlled Study
Nurse's Role, Empathy
Not yet recruitingObservational study
Mobilization of Emotions and Empathy During Communication Training in Nursing Students
Education Nursing, Communication Skills
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.
Chia-Jung Hsieh, PhD study director
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR films in people with Empathy and Attitude, run by National Taipei University of Nursing and Health Sciences 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 4 inclusion and 2 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 15 Sep 2022. 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?
Empathy Scale (time frame: Change from Baseline, T1). The study lists 3 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 NCT05541575, which also lists 10 linked publications.
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 15 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.