CompetenceVRE-ABCNCT06797180
VR-Based Intervention for Caregiving Competence in Dementia
A study testing Virtual Reality Education for Dementia Caregivers in people with Competence, run by Mackay Medical College at 1 site in Taiwan.
Trial summary
This study aims to develop and evaluate the effectiveness of a VR-based educational intervention designed to improve the dementia caregiving abilities of formal caregivers in residential care homes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Competence
- What is being tested?
- Virtual Reality Education for Dementia Caregivers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 May 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Able to communicate in Mandarin or Taiwanese.
- A formal caregiver of individuals with dementia.
- At least one month of work experience in the residential care facility.
Who cannot join
- Caregivers who do not meet the above inclusion criteria.
- Individuals who are unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Virtual Reality-Based Educational Intervention in Enhancing Caregiving Competence for Managing Agitated Behaviors in Dementia Residents: A Randomized Controlled Trial
This study aims to develop and evaluate the effectiveness of a VR-based educational intervention designed to improve the dementia caregiving abilities of formal caregivers in residential care homes. The intervention focuses on enhancing caregivers' knowledge and skills in managing behavioral symptoms of dementia through immersive VR scenarios, group discussions, and evidence-based management strategies, with the goal of better equipping them to provide high-quality care for residents with dementia.
Read the detailed description
Background:
Agitated behaviors, such as aggression, care resistance, and wandering, are common in dementia and present significant challenges for formal caregivers in long-term care (LTC) facilities. These behaviors often stem from unmet needs, such as pain, discomfort, or communication barriers, contributing to caregiver stress and reduced care quality. Virtual reality (VR) technology offers an immersive, first-person experience that enables caregivers to better understand triggers of agitated behaviors, empathize with residents' experiences, and improve their caregiving abilities.
Purpose:
This study aims to develop and evaluate the effectiveness of a VR-based educational intervention for formal caregivers in residential care homes. Specifically, the study compares two groups: (1) an experimental group receiving both a 100-minute behavioral and psychological symptom (BPSD) foundational education and an additional 100-minute VR training program, and (2) a control group receiving only the 100-minute BPSD foundational education. The study evaluates three outcomes: (1) dementia care competence, (2) confidence in caregiving, and (3) self-reported frequency of BPSD assessment and management at pre-intervention, post-intervention, and two-week follow-up.
Methods:
The VR scenarios and training intervention were developed through a systematic literature review, four focus group interviews with formal caregivers, and pilot testing in a residential LTC facility in Northern Taiwan. A single-blind randomized controlled trial with repeated measures design was conducted across six LTC facilities. The experimental group received 100 minutes of BPSD foundational education, covering an overview of BPSD, identification of common symptoms, strategies for managing BPSD, and the role of caregivers. Additionally, they participated in 100 minutes of VR-based training, which included 20 minutes of immersive VR scenarios to experience at least two types of BPSD, 20 minutes of group discussion to share practical strategies, 20 minutes of evidence-based explanation of management techniques, 15 minutes for scenario reflection, and 25 minutes for Q\&A and summarization. The control group, however, only received the 100-minute BPSD foundational education without the VR component. Resident data, including demographics, medical conditions, and Barthel Index scores, were collected. Outcome measures included the Dementia Competence Scale (DCS) , self-reported confidence in caregiving and weekly self-reported BPSD assessment and management frequencies. Data analysis utilized SPSS 25.0, applying descriptive statistics and mixed linear models to examine within- and between-group improvements over time.
- Conditions
- Competence
- Being tested
- Virtual Reality Education for Dementia Caregivers
- Keywords
- Behavioral and Psychological Symptoms of Dementia (BPSD), Caregiving Competence, Dementia Care, Virtual Reality Education, Residential care homes
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Education for Dementia CaregiversDevice
This group will receive 100 minutes of BPSD foundational education followed by 100 minutes of VR-based training focused on managing BPSD.
| Study group | Role | What they receive |
|---|---|---|
| This group will receive BPSD foundational education followed by VR-based training. | Experimental | The intervention consists of two components:
1. BPSD Foundational Education: A 100-minute educational session covering an overview of BPSD, identification of common symptoms, strategies for managing BPSD, and the role of caregivers.
2. VR-based Training: A 100-minute VR-based training, including 20 minutes of immersive VR scenarios to experience at least two types of BPSD, 20 minutes of group discussion to share practical strategies, and 20 minutes of evidence-based explanation of management techniques, 15 minutes for scenario reflection, and 25 minutes for Q\&A and summarization. Receives: Device: Virtual Reality Education for Dementia Caregivers |
| This group will only receive BPSD foundational education. | No intervention | The control group will only receive the 100-minute BPSD foundational education, which covers the same topics as the experimental group but without the VR-based training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caregiving ability scores before intervention to post-intervention and follow-up.
Caregiving ability was measured using the Dementia Competence Scale for Acute Care (DCS) developed by Yang, Yang, Hsiao, Kuo, and Wang (2021). This scale includes three subscales: 13 items on knowledge, 11 items on attitudes, and 9 items on skills. The Cronbach's α values for the knowledge, attitude, and skills subscales were 0.88, 0.94, and 0.85, respectively. The test-retest reliability, as measured by the intraclass correlation coefficient (ICC), was 0.82 for the overall scale, with 0.87 for the knowledge subscale, 0.64 for the attitude subscale, and 0.74 for the skills subscale.
Measured: Data will be collected before the intervention (baseline), immediately post-intervention (after training), and at follow-up (two weeks after the intervention).
Confidence in assessing and managing BPSD
Confidence in assessing BPSD (Behavioral and Psychological Symptoms of Dementia) and in effectively managing BPSD was evaluated using a 5-point scale, ranging from "very unconfident" to "very confident."
Measured: Data will be collected before the intervention (baseline), immediately post-intervention (after training), and at follow-up (two weeks after the intervention).
Secondary outcomes (1)
Change in frequency of assessment and management of BPSD before intervention to post-intervention and follow-up.
This measure includes the frequency of:
Assessment and documentation of dementia-related problem behaviors over the past week.
Pharmacological interventions, non-pharmacological interventions, and the referral frequency for dementia-related behaviors over the past week.
Measured: Data will be collected before the intervention (baseline), at 1 week post-intervention, and at follow-up (two weeks after the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start31 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CompetenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin-Tsung Shen, Mackay Medical College
- Investigators
- Principal Investigator, Principal investigator, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797180
- Sponsor's protocol ID
- MMC-RD-112-1B-P004
- Other IDs
- MOST 111-2314-B-715-004-MY3
- Acronym
- VRE-ABC
- Status last verified
- Apr 2025
- First submitted
- 22 Jan 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality-Based Educational Intervention in Enhancing Caregiving Competence for Managing Agitated Behaviors in Dementia Residents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06797180
- Acronym / sponsor ID
- VRE-ABC / MMC-RD-112-1B-P004
- Conditions
- Competence
- Keywords
- Behavioral and Psychological Symptoms of Dementia (BPSD), Caregiving Competence, Dementia Care, Virtual Reality Education, Residential care homes
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mackay Medical CollegeUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jan 2025 (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 aims to develop and evaluate the effectiveness of a VR-based educational intervention designed to improve the dementia caregiving abilities of formal caregivers in residential care homes. The intervention focuses on enhancing caregivers' knowledge and skills in managing behavioral symptoms of dementia through immersive VR scenarios, group discussions, and evidence-based management strategies, with the goal of better equipping them to provide high-quality care for residents with dementia.
Detailed description
Background:
Agitated behaviors, such as aggression, care resistance, and wandering, are common in dementia and present significant challenges for formal caregivers in long-term care (LTC) facilities. These behaviors often stem from unmet needs, such as pain, discomfort, or communication barriers, contributing to caregiver stress and reduced care quality. Virtual reality (VR) technology offers an immersive, first-person experience that enables caregivers to better understand triggers of agitated behaviors, empathize with residents' experiences, and improve their caregiving abilities.
Purpose:
This study aims to develop and evaluate the effectiveness of a VR-based educational intervention for formal caregivers in residential care homes. Specifically, the study compares two groups: (1) an experimental group receiving both a 100-minute behavioral and psychological symptom (BPSD) foundational education and an additional 100-minute VR training program, and (2) a control group receiving only the 100-minute BPSD foundational education. The study evaluates three outcomes: (1) dementia care competence, (2) confidence in caregiving, and (3) self-reported frequency of BPSD assessment and management at pre-intervention, post-intervention, and two-week follow-up.
Methods:
The VR scenarios and training intervention were developed through a systematic literature review, four focus group interviews with formal caregivers, and pilot testing in a residential LTC facility in Northern Taiwan. A single-blind randomized controlled trial with repeated measures design was conducted across six LTC facilities. The experimental group received 100 minutes of BPSD foundational education, covering an overview of BPSD, identification of common symptoms, strategies for managing BPSD, and the role of caregivers. Additionally, they participated in 100 minutes of VR-based training, which included 20 minutes of immersive VR scenarios to experience at least two types of BPSD, 20 minutes of group discussion to share practical strategies, 20 minutes of evidence-based explanation of management techniques, 15 minutes for scenario reflection, and 25 minutes for Q\&A and summarization. The control group, however, only received the 100-minute BPSD foundational education without the VR component. Resident data, including demographics, medical conditions, and Barthel Index scores, were collected. Outcome measures included the Dementia Competence Scale (DCS) , self-reported confidence in caregiving and weekly self-reported BPSD assessment and management frequencies. Data analysis utilized SPSS 25.0, applying descriptive statistics and mixed linear models to examine within- and between-group improvements over time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| This group will receive BPSD foundational education followed by VR-based training. | Experimental | Device: Virtual Reality Education for Dementia CaregiversThe intervention consists of two components: 1. BPSD Foundational Education: A 100-minute educational session covering an overview of BPSD, identification of common symptoms, strategies for managing BPSD, and the role of caregivers. 2. VR-based Training: A 100-minute VR-based training, including 20 minutes of immersive VR scenarios to experience at least two types of BPSD, 20 minutes of group discussion to share practical strategies, and 20 minutes of evidence-based explanation of management techniques, 15 minutes for scenario reflection, and 25 minutes for Q\&A and summarization. |
| This group will only receive BPSD foundational education. | No intervention | –The control group will only receive the 100-minute BPSD foundational education, which covers the same topics as the experimental group but without the VR-based training. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older.
- Able to communicate in Mandarin or Taiwanese.
- A formal caregiver of individuals with dementia.
- At least one month of work experience in the residential care facility.
Key exclusion criteria (2 listed)
- Caregivers who do not meet the above inclusion criteria.
- Individuals who are unable or unwilling to provide informed consent.
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 |
|---|---|---|
| Virtual Reality Education for Dementia CaregiversThis group will receive 100 minutes of BPSD foundational education followed by 100 minutes of VR-based training focused on managing BPSD. | Device | This group will receive BPSD foundational education followed by VR-based training. |
Primary outcome
Change in caregiving ability scores before intervention to post-intervention and follow-up.
Time frame: Data will be collected before the intervention (baseline), immediately post-intervention (after training), and at follow-up (two weeks after the intervention).
Caregiving ability was measured using the Dementia Competence Scale for Acute Care (DCS) developed by Yang, Yang, Hsiao, Kuo, and Wang (2021). This scale includes three subscales: 13 items on knowledge, 11 items on attitudes, and 9 items on skills. The Cronbach's α values for the knowledge, attitude, and skills subscales were 0.88, 0.94, and 0.85, respectively. The test-retest reliability, as measured by the intraclass correlation coefficient (ICC), was 0.82 for the overall scale, with 0.87 for the knowledge subscale, 0.64 for the attitude subscale, and 0.74 for the skills subscale.
Confidence in assessing and managing BPSD
Time frame: Data will be collected before the intervention (baseline), immediately post-intervention (after training), and at follow-up (two weeks after the intervention).
Confidence in assessing BPSD (Behavioral and Psychological Symptoms of Dementia) and in effectively managing BPSD was evaluated using a 5-point scale, ranging from "very unconfident" to "very confident."
1 secondary outcome
Change in frequency of assessment and management of BPSD before intervention to post-intervention and follow-up.
Time frame: Data will be collected before the intervention (baseline), at 1 week post-intervention, and at follow-up (two weeks after the intervention).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Principal Investigator principal investigator
School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Education for Dementia Caregivers in people with Competence, run by Mackay Medical College 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: enrolling by invitation, as of the sponsor's last update on 30 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in caregiving ability scores before intervention to post-intervention and follow-up. (time frame: Data will be collected before the intervention (baseline), immediately post-intervention (after training), and at follow-up (two weeks after the intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2025.