Clinical trial NCT06797180: VR-Based Intervention for Caregiving Competence in Dementia
Official title: Effectiveness of Virtual Reality-Based Educational Intervention in Enhancing Caregiving Competence for Managing Agitated Behaviors in Dementia Residents: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Competence
Keywords: Behavioral and Psychological Symptoms of Dementia (BPSD)
Caregiving Competence
Dementia Care
Virtual Reality Education
Residential care homes
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older.
2. Able to communicate in Mandarin or Taiwanese.
3. A formal caregiver of individuals with dementia.
4. At least one month of work experience in the residential care facility.

Exclusion Criteria:

1. Caregivers who do not meet the above inclusion criteria.
2. Individuals who are unable or unwilling to provide informed consent.

Primary outcomes:
measure: Change in caregiving ability scores before intervention to post-intervention and follow-up.
timeFrame: Data will be collected before the intervention (baseline), immediately post-intervention (after training), and at follow-up (two weeks after the intervention).
measure: Confidence in assessing and managing BPSD
timeFrame: Data will be collected before the intervention (baseline), immediately post-intervention (after training), and at follow-up (two weeks after the intervention).
Secondary outcomes:
measure: Change in frequency of assessment and management of BPSD before intervention to post-intervention and follow-up.
timeFrame: Data will be collected before the intervention (baseline), at 1 week post-intervention, and at follow-up (two weeks after the intervention).
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of Nursing
Study officials:
affiliation: School of Nursing
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: