Virtual Reality Intervention for Family Caregivers of Persons Living With Dementia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia
• Intervention / Treatment: Behavioral: virtual reality intervention

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yea-Ing Shyu, PhD; Phone Number: +886978697460; Email: yeaing@mail.cgu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- has the primary responsibility for providing direct care or supervising the care received by the PLWD, and is living with the PLWD.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality; virtual interventions using VR scenarios related to competing demands for family caregivers of PLWD	Behavioral: virtual reality intervention; virtual interventions using VR scenarios related to competing demands for family caregivers of PLWD
No Intervention: information; information regarding dementia will be provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiving Balance	The balance between competing needs will be assessed using the Caregiving Process of Finding a Balance Point scale	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	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	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)	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)	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)	6th month following VR intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 ).	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 ).	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 ).	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.	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.	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.	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	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	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	6th month following VR intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiving demands	The FCI Caregiving Activities Scales (Archbold, et al., 1990) will measure caregiving demand.	1st month following VR intervention
Caregiving demands	The FCI Caregiving Activities Scales (Archbold, et al., 1990) will measure caregiving demand.	3rd month following VR intervention
Caregiving demands	The FCI Caregiving Activities Scales (Archbold, et al., 1990) will measure caregiving demand.	6th month following VR intervention

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Yea-Ing Shyu, Chang Gung University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: dementia; virtual reality; family caregiver
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 114-2314-B-182-048-MY3

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