DementiaNCT07248345
Virtual Reality Intervention for Family Caregivers of Persons Living With Dementia
A study testing virtual reality intervention in people with Dementia, run by Chang Gung Memorial Hospital.
Trial summary
This study explores the effects of a virtual reality intervention on family caregivers of persons living with dementia Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Dementia
- What is being tested?
- virtual reality intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- has the primary responsibility for providing direct care or supervising the care received by the PLWD, and is living with the PLWD.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Machine Learning-enhanced Virtual Reality Intervention to Facilitate Balance Finding for Family Caregivers of Persons Living With Dementia
This study explores the effects of a virtual reality intervention on family caregivers of persons living with dementia
Read the detailed description
Virtual interventions using VR scenarios related to competing demands for family caregivers of persons living with dementia that facilitate caregiving balance will be developed. Tts effects will be investigated by using a randomized controlled trial.
- Conditions
- Dementia
- Being tested
- virtual reality intervention
- Keywords
- family caregiver, dementia, virtual reality
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality interventionBehavioural
virtual interventions using VR scenarios related to competing demands for family caregivers of PLWD
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | virtual interventions using VR scenarios related to competing demands for family caregivers of PLWD Receives: Behavioral: virtual reality intervention |
| information | No intervention | information regarding dementia will be provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiving Balance
The balance between competing needs will be assessed using the Caregiving Process of Finding a Balance Point scale
Measured: 1st month follwing VR intervention
Caregiving Balance
The balance between competing needs will be assessed using the Caregiving Process of Finding a Balance Point scale
Measured: 3rd month follwing VR intervention
Caregiving Balance
The balance between competing needs will be assessed using the Caregiving Process of Finding a Balance Point scale
Measured: 6th month follwing VR intervention
Caregiver role strain
Role strain will be measured by the 87-item Role Strain Scale from the Family Caregiving Inventory (FCI)
Measured: 1st month following VR intervention
Caregiver role strain
Role strain will be measured by the 87-item Role Strain Scale from the Family Caregiving Inventory (FCI)
Measured: 3rd month following VR intervention
Caregiver role strain
Role strain will be measured by the 87-item Role Strain Scale from the Family Caregiving Inventory (FCI)
Measured: 6th month following VR intervention
Secondary outcomes (9)
Health Related Quality of Life
Physical functioning, role physical, bodily pain, vitality, general health, social functioning, role emotional, and mental health will be assessed with the 36-item Short Form Health Survey (SF-36 ).
Measured: 1st month following VR intervention
Health Related Quality of Life
Physical functioning, role physical, bodily pain, vitality, general health, social functioning, role emotional, and mental health will be assessed with the 36-item Short Form Health Survey (SF-36 ).
Measured: 3rd month following VR intervention
Health Related Quality of Life
Physical functioning, role physical, bodily pain, vitality, general health, social functioning, role emotional, and mental health will be assessed with the 36-item Short Form Health Survey (SF-36 ).
Measured: 6th month following VR intervention
Depressive symptoms
The Chinese version of the 20-item Center for Epidemiologic Studies Depression Scale (CES-D will assess depressive symptoms.
Measured: 1st month following VR intervention
Depressive symptoms
The Chinese version of the 20-item Center for Epidemiologic Studies Depression Scale (CES-D will assess depressive symptoms.
Measured: 3rd month following VR intervention
Depressive symptoms
The Chinese version of the 20-item Center for Epidemiologic Studies Depression Scale (CES-D will assess depressive symptoms.
Measured: 6th month following VR intervention
Caregiving Rewards
The FCI Rewards of Caregiving scale (Archbold, et al., 1990) will be used to assess positive outcomes of caregiving
Measured: 1st month following VR intervention
Caregiving Rewards
The FCI Rewards of Caregiving scale (Archbold, et al., 1990) will be used to assess positive outcomes of caregiving
Measured: 3rd month following VR intervention
Caregiving Rewards
The FCI Rewards of Caregiving scale (Archbold, et al., 1990) will be used to assess positive outcomes of caregiving
Measured: 6th month following VR intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Jun 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yea-Ing Shyu, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248345
- Sponsor's protocol ID
- 114-2314-B-182-048-MY3
- Status last verified
- Aug 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Machine Learning-enhanced Virtual Reality Intervention to Facilitate Balance Finding for Family Caregivers of Persons Living With Dementia
- ClinicalTrials.gov ID
- NCT07248345
- Acronym / sponsor ID
- 114-2314-B-182-048-MY3
- Conditions
- Dementia
- Keywords
- family caregiver, dementia, virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 25 Nov 2025 (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 explores the effects of a virtual reality intervention on family caregivers of persons living with dementia
Detailed description
Virtual interventions using VR scenarios related to competing demands for family caregivers of persons living with dementia that facilitate caregiving balance will be developed. Tts effects will be investigated by using a randomized controlled trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Behavioral: virtual reality interventionvirtual interventions using VR scenarios related to competing demands for family caregivers of PLWD |
| information | No intervention | –information regarding dementia will be provided |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- has the primary responsibility for providing direct care or supervising the care received by the PLWD, and is living with the PLWD.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| virtual reality interventionvirtual interventions using VR scenarios related to competing demands for family caregivers of PLWD | Behavioural | virtual reality |
Primary outcome
Caregiving Balance
Time frame: 1st month follwing VR intervention
The balance between competing needs will be assessed using the Caregiving Process of Finding a Balance Point scale
Caregiving Balance
Time frame: 3rd month follwing VR intervention
The balance between competing needs will be assessed using the Caregiving Process of Finding a Balance Point scale
Caregiving Balance
Time frame: 6th month follwing VR intervention
The balance between competing needs will be assessed using the Caregiving Process of Finding a Balance Point scale
Caregiver role strain
Time frame: 1st month following VR intervention
Role strain will be measured by the 87-item Role Strain Scale from the Family Caregiving Inventory (FCI)
Caregiver role strain
Time frame: 3rd month following VR intervention
Role strain will be measured by the 87-item Role Strain Scale from the Family Caregiving Inventory (FCI)
Caregiver role strain
Time frame: 6th month following VR intervention
Role strain will be measured by the 87-item Role Strain Scale from the Family Caregiving Inventory (FCI)
9 secondary outcomes
Health Related Quality of Life
Time frame: 1st month following VR intervention
Health Related Quality of Life
Time frame: 3rd month following VR intervention
Health Related Quality of Life
Time frame: 6th month following VR intervention
Depressive symptoms
Time frame: 1st month following VR intervention
Depressive symptoms
Time frame: 3rd month following VR intervention
Depressive symptoms
Time frame: 6th month following VR intervention
Caregiving Rewards
Time frame: 1st month following VR intervention
Caregiving Rewards
Time frame: 3rd month following VR intervention
Caregiving Rewards
Time frame: 6th month following VR intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Yea-Ing Shyu principal investigator
Chang Gung University
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality intervention in people with Dementia, run by Chang Gung Memorial Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yea-Ing Shyu, PhD (+886978697460, yeaing@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiving Balance (time frame: 1st month follwing VR intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2025.