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Enrolling by Invitation

NCT Number: NCT06797180

VR-Based Intervention for Caregiving Competence in Dementia

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nursing

New Taipei City, 252005, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Education for Dementia Caregivers

Device

This group will receive 100 minutes of BPSD foundational education followed by 100 minutes of VR-based training focused on managing BPSD.

Primary outcomes

  1. 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.

  2. 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."

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mackay Medical College

Other

Registry information

Official study title

Effectiveness of Virtual Reality-Based Educational Intervention in Enhancing Caregiving Competence for Managing Agitated Behaviors in Dementia Residents: A Randomized Controlled Trial

Acronym: VRE-ABC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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