A Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia

December 13, 2025 updated by: Huei-Chuan Sung, Tzu Chi University

A Randomized Controlled Trial of a Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia

This study aims to evaluate a care empowerment program using virtual reality on dementia knowledge, attitude, self-efficacy in managing BPSD, empathy and caregiver burden of family caregivers of people with dementia.

Study Overview

Detailed Description

The majority of patients with dementia live at home and cared by their families in Taiwan. Most of family caregivers have limited knowledge and care skills of dementia, therefore they experience great stress and caregiver burden which may have negative impact on their physical and mental health.

This two-group randomised controlled trial aims to evaluate a care empowerment program using virtual reality on dementia knowledge, attitude, care self-efficacy in managing BPSD, empathy and caregiver burden of family caregivers of people with dementia.

The intervention group will receive the Care Empowerment Program, which consists of dementia care e-books and virtual reality-based dementia activities, in addition to the routine dementia care manual and family support group.

The control group will only receive routine dementia care manual and family support group with no dementia virtual reality activity.

Both groups will be assessed for their dementia knowledge, attitudes, self-efficacy in managing BPSD, empathy and caregiver burden at baseline, month 3, and 4.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hualien City, Taiwan, 970
        • TCU dementia day center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age 20 to 90 years,
  • Taiwanese nationality,
  • have provided care for relatives with dementia or cognitive impairment for at least three months,
  • have a mobile phone or tablet and regular access to the internet,
  • provide informed consent to participate in the study.

Exclusion Criteria:

  • family members who do not meet the inclusion criteria,
  • can not provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
care empowerment program
dementia care e-books and dementia virtual reality activity in addition to the routine dementia care manual and family support group
Active Comparator: Control group
routine family support
routine dementia care manual and family support group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dementia Knowledge Assessment Scale (DKAS)
Time Frame: baseline
score of knowledge about dementia
baseline
Dementia Knowledge Assessment Scale (DKAS)
Time Frame: month 3
score of knowledge about dementia
month 3
Dementia Knowledge Assessment Scale (DKAS)
Time Frame: month 4
score of knowledge about dementia
month 4
Approaches to Dementia Questionnaire (ADQ)
Time Frame: baseline
score of attitude toward people with dementia
baseline
Approaches to Dementia Questionnaire (ADQ)
Time Frame: month 3
score of attitude toward people with dementia
month 3
Approaches to Dementia Questionnaire (ADQ)
Time Frame: month 4
score of attitude toward people with dementia
month 4
Revised Interpersonal Reactivity Index (R-IRI)
Time Frame: baseline
empathy toward people with dementia
baseline
Revised Interpersonal Reactivity Index (R-IRI)
Time Frame: month 3
empathy toward people with dementia
month 3
Revised Interpersonal Reactivity Index (R-IRI)
Time Frame: month 4
empathy toward people with dementia
month 4
Family Caregiver Competence Questionnaire (FACCQ)
Time Frame: baseline
score of FACCQ
baseline
Family Caregiver Competence Questionnaire (FACCQ)
Time Frame: month 3
score of FACCQ
month 3
Family Caregiver Competence Questionnaire (FACCQ)
Time Frame: month 4
score of FACCQ
month 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Burden Inventory (CBI)
Time Frame: baseline
score of caregiver burden for caring for people with dementia
baseline
Caregiver Burden Inventory (CBI)
Time Frame: month 3
score of caregiver burden for caring for people with dementia
month 3
Caregiver Burden Inventory (CBI)
Time Frame: month 4
score of caregiver burden for caring for people with dementia
month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

July 18, 2022

First Submitted That Met QC Criteria

July 24, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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