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CompletedNCT05475002Updated Dec 19, 2025

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

An interventional study of care empowerment program and Routine family support in Dementia Family Caregiver, sponsored by Tzu Chi University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Tzu Chi University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dementia Family Caregiver

Keywords

  • family caregiver
  • dementia
  • virtual reality
  • empowerment
03

In context

Dementia

2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.

This study's enrollment of 92 is close to the median of 90 across 1,758 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Tzu Chi University is the lead sponsor of 20 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • family members who do not meet the inclusion criteria,
  • can not provide .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    Intervention group

    care empowerment program

    Other: care empowerment program

  • Active comparator
    Control group

    routine family support

    Other: Routine family support

Interventions

  • Othercare empowerment program

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

  • OtherRoutine family support

    routine dementia care manual and family support group

06

What researchers measure

Primary outcomes

  1. Dementia Knowledge Assessment Scale (DKAS)

    score of knowledge about dementia

    Time frame: baseline

  2. Dementia Knowledge Assessment Scale (DKAS)

    score of knowledge about dementia

    Time frame: month 3

  3. Dementia Knowledge Assessment Scale (DKAS)

    score of knowledge about dementia

    Time frame: month 4

  4. Approaches to Dementia Questionnaire (ADQ)

    score of attitude toward people with dementia

    Time frame: baseline

  5. Approaches to Dementia Questionnaire (ADQ)

    score of attitude toward people with dementia

    Time frame: month 3

  6. Approaches to Dementia Questionnaire (ADQ)

    score of attitude toward people with dementia

    Time frame: month 4

  7. Family Caregiver Competence Questionnaire (FACCQ)

    score of FACCQ

    Time frame: baseline

  8. Family Caregiver Competence Questionnaire (FACCQ)

    score of FACCQ

    Time frame: month 3

  9. Family Caregiver Competence Questionnaire (FACCQ)

    score of FACCQ

    Time frame: month 4

  10. Revised Interpersonal Reactivity Index (R-IRI)

    empathy toward people with dementia

    Time frame: baseline

  11. Revised Interpersonal Reactivity Index (R-IRI)

    empathy toward people with dementia

    Time frame: month 3

  12. Revised Interpersonal Reactivity Index (R-IRI)

    empathy toward people with dementia

    Time frame: month 4

Secondary outcomes

  1. Caregiver Burden Inventory (CBI)

    score of caregiver burden for caring for people with dementia

    Time frame: baseline

  2. Caregiver Burden Inventory (CBI)

    score of caregiver burden for caring for people with dementia

    Time frame: month 3

  3. Caregiver Burden Inventory (CBI)

    score of caregiver burden for caring for people with dementia

    Time frame: month 4

07

Study locations

1 site
  • TCU dementia day center
    Hualien City, 970, Taiwan
08

References and documents

Publications

  • 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. PubMed 41791987 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05475002
Lead sponsor
Tzu Chi University
Responsible party
Huei-Chuan Sung (Associate professor, Tzu Chi University) — Principal investigator
First posted
Jul 26, 2022
Start date
Aug 1, 2022
Primary completion
Jul 1, 2023
Completion
Jul 1, 2023
Last update
Dec 19, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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