Dementia Family CaregiverNCT05475002
A Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia
A study testing care empowerment program and Routine family support in people with Dementia Family Caregiver, run by Tzu Chi University at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia Family Caregiver
- What is being tested?
- care empowerment program and Routine family support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- family members who do not meet the inclusion criteria,
- can not provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Dementia Family Caregiver
- Being tested
- care empowerment program, Routine family support
- Keywords
- family caregiver, dementia, virtual reality, empowerment
- Medical subject headings
- Dementia, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care empowerment programOther
dementia care e-books and dementia virtual reality activity in addition to the routine dementia care manual and family support group
Routine family supportOther
routine dementia care manual and family support group
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | care empowerment program Receives: Other: care empowerment program |
| Control group | Active comparator | routine family support Receives: Other: Routine family support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia Knowledge Assessment Scale (DKAS)
score of knowledge about dementia
Measured: baseline
Dementia Knowledge Assessment Scale (DKAS)
score of knowledge about dementia
Measured: month 3
Dementia Knowledge Assessment Scale (DKAS)
score of knowledge about dementia
Measured: month 4
Approaches to Dementia Questionnaire (ADQ)
score of attitude toward people with dementia
Measured: baseline
Approaches to Dementia Questionnaire (ADQ)
score of attitude toward people with dementia
Measured: month 3
Approaches to Dementia Questionnaire (ADQ)
score of attitude toward people with dementia
Measured: month 4
Family Caregiver Competence Questionnaire (FACCQ)
score of FACCQ
Measured: baseline
Family Caregiver Competence Questionnaire (FACCQ)
score of FACCQ
Measured: month 3
Family Caregiver Competence Questionnaire (FACCQ)
score of FACCQ
Measured: month 4
Revised Interpersonal Reactivity Index (R-IRI)
empathy toward people with dementia
Measured: baseline
Revised Interpersonal Reactivity Index (R-IRI)
empathy toward people with dementia
Measured: month 3
Revised Interpersonal Reactivity Index (R-IRI)
empathy toward people with dementia
Measured: month 4
Secondary outcomes (3)
Caregiver Burden Inventory (CBI)
score of caregiver burden for caring for people with dementia
Measured: baseline
Caregiver Burden Inventory (CBI)
score of caregiver burden for caring for people with dementia
Measured: month 3
Caregiver Burden Inventory (CBI)
score of caregiver burden for caring for people with dementia
Measured: month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Aug 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia Family CaregiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-group randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tzu Chi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huei-Chuan Sung, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475002
- Sponsor's protocol ID
- YLH-IRB-11104
- Status last verified
- Dec 2025
- First submitted
- 18 Jul 2022
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia
- ClinicalTrials.gov ID
- NCT05475002
- Acronym / sponsor ID
- YLH-IRB-11104
- Conditions
- Dementia Family Caregiver
- Keywords
- family caregiver, dementia, virtual reality, empowerment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Tzu Chi UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two-group randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: care empowerment programcare empowerment program |
| Control group | Active comparator | Other: Routine family supportroutine family support |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- family members who do not meet the inclusion criteria,
- can not provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| care empowerment programdementia care e-books and dementia virtual reality activity in addition to the routine dementia care manual and family support group | Other | Intervention group |
| Routine family supportroutine dementia care manual and family support group | Other | Control group |
Primary outcome
Dementia Knowledge Assessment Scale (DKAS)
Time frame: baseline
score of knowledge about dementia
Dementia Knowledge Assessment Scale (DKAS)
Time frame: month 3
score of knowledge about dementia
Dementia Knowledge Assessment Scale (DKAS)
Time frame: month 4
score of knowledge about dementia
Approaches to Dementia Questionnaire (ADQ)
Time frame: baseline
score of attitude toward people with dementia
Approaches to Dementia Questionnaire (ADQ)
Time frame: month 3
score of attitude toward people with dementia
Approaches to Dementia Questionnaire (ADQ)
Time frame: month 4
score of attitude toward people with dementia
Family Caregiver Competence Questionnaire (FACCQ)
Time frame: baseline
score of FACCQ
Family Caregiver Competence Questionnaire (FACCQ)
Time frame: month 3
score of FACCQ
Family Caregiver Competence Questionnaire (FACCQ)
Time frame: month 4
score of FACCQ
Revised Interpersonal Reactivity Index (R-IRI)
Time frame: baseline
empathy toward people with dementia
Revised Interpersonal Reactivity Index (R-IRI)
Time frame: month 3
empathy toward people with dementia
Revised Interpersonal Reactivity Index (R-IRI)
Time frame: month 4
empathy toward people with dementia
3 secondary outcomes
Caregiver Burden Inventory (CBI)
Time frame: baseline
Caregiver Burden Inventory (CBI)
Time frame: month 3
Caregiver Burden Inventory (CBI)
Time frame: month 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Derived from this study: PubMed 41791987Sung 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.
- Individual participant dataSharing planned: No
Related trials for Dementia Family Caregiver
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The WeACT Program for Family Caregivers of People Living With Dementia
Depression, Caregivers
Recruiting
Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
Caregivers
Not yet recruitingPhase 2
Peer Support for Family Caregivers of Older Adults Living With Dementia
Caregiver Burden, Caregiver Burnout
Active, not recruiting
Mindfulness-based Movement Therapy for Persons With Dementia and Family Caregivers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care empowerment program and Routine family support in people with Dementia Family Caregiver, run by Tzu Chi University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dementia Knowledge Assessment Scale (DKAS) (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05475002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.