NCT05475002

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

July 18, 2022

Last Update Submit

December 13, 2025

Conditions

Keywords

family caregiverdementiavirtual realityempowerment

Outcome Measures

Primary Outcomes (12)

  • Dementia Knowledge Assessment Scale (DKAS)

    score of knowledge about dementia

    baseline

  • Dementia Knowledge Assessment Scale (DKAS)

    score of knowledge about dementia

    month 3

  • Dementia Knowledge Assessment Scale (DKAS)

    score of knowledge about dementia

    month 4

  • Approaches to Dementia Questionnaire (ADQ)

    score of attitude toward people with dementia

    baseline

  • Approaches to Dementia Questionnaire (ADQ)

    score of attitude toward people with dementia

    month 3

  • Approaches to Dementia Questionnaire (ADQ)

    score of attitude toward people with dementia

    month 4

  • Family Caregiver Competence Questionnaire (FACCQ)

    score of FACCQ

    baseline

  • Family Caregiver Competence Questionnaire (FACCQ)

    score of FACCQ

    month 3

  • Family Caregiver Competence Questionnaire (FACCQ)

    score of FACCQ

    month 4

  • Revised Interpersonal Reactivity Index (R-IRI)

    empathy toward people with dementia

    baseline

  • Revised Interpersonal Reactivity Index (R-IRI)

    empathy toward people with dementia

    month 3

  • Revised Interpersonal Reactivity Index (R-IRI)

    empathy toward people with dementia

    month 4

Secondary Outcomes (3)

  • Caregiver Burden Inventory (CBI)

    baseline

  • Caregiver Burden Inventory (CBI)

    month 3

  • Caregiver Burden Inventory (CBI)

    month 4

Study Arms (2)

Intervention group

EXPERIMENTAL

care empowerment program

Other: care empowerment program

Control group

ACTIVE COMPARATOR

routine family support

Other: Routine family support

Interventions

dementia care e-books and dementia virtual reality activity in addition to the routine dementia care manual and family support group

Intervention group

routine dementia care manual and family support group

Control group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • can not provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TCU dementia day center

Hualien City, 970, Taiwan

Location

Related Publications (1)

  • Sung HC, Su HF, Lee WL, Chin MY, Wang HM, Huang HJ, Chu CH. A multicomponent dementia education and support program for family caregivers: A randomized controlled trial. Int Psychogeriatr. 2026 Mar 5:100202. doi: 10.1016/j.inpsyc.2026.100202. Online ahead of print.

MeSH Terms

Conditions

DementiaEmpowerment

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: two-group randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 26, 2022

Study Start

August 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations