NCT06797180

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

2.6 years

First QC Date

January 22, 2025

Last Update Submit

April 29, 2025

Conditions

Keywords

Behavioral and Psychological Symptoms of Dementia (BPSD)Caregiving CompetenceDementia CareVirtual Reality EducationResidential care homes

Outcome Measures

Primary Outcomes (2)

  • 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.

    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."

    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.

    Data will be collected before the intervention (baseline), at 1 week post-intervention, and at follow-up (two weeks after the intervention).

Study Arms (2)

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.

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.

Interventions

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

This group will receive BPSD foundational education followed by VR-based training.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals who are unable or unwilling to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing

New Taipei City, New Taipei City, 252005, Taiwan

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Principal Investigator

    School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Office of Research and Development

Study Record Dates

First Submitted

January 22, 2025

First Posted

January 28, 2025

Study Start

May 31, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations