- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06797180
VR-Based Intervention for Caregiving Competence in Dementia (VRE-ABC)
Effectiveness of Virtual Reality-Based Educational Intervention in Enhancing Caregiving Competence for Managing Agitated Behaviors in Dementia Residents: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
New Taipei City, Taiwan, 252005
- Department of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Caregivers who do not meet the above inclusion criteria.
- Individuals who are unable or unwilling to provide informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: This group will receive BPSD foundational education followed by VR-based training.
The intervention consists of two components:
|
This group will receive 100 minutes of BPSD foundational education followed by 100 minutes of VR-based training focused on managing BPSD.
|
|
No Intervention: This group will only receive BPSD foundational education.
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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."
|
Data will be collected before the intervention (baseline), immediately post-intervention (after training), and at follow-up (two weeks after the intervention).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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. |
Data will be collected before the intervention (baseline), at 1 week post-intervention, and at follow-up (two weeks after the intervention).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Principal Investigator, School of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMC-RD-112-1B-P004
- MOST 111-2314-B-715-004-MY3 (Other Grant/Funding Number: National Science and Technology council)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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