- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05475002
A Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia
A Randomized Controlled Trial of a Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hualien City, Taiwan, 970
- TCU dementia day center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 informed consent to participate in the study.
Exclusion Criteria:
- family members who do not meet the inclusion criteria,
- can not provide informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
care empowerment program
|
dementia care e-books and dementia virtual reality activity in addition to the routine dementia care manual and family support group
|
|
Active Comparator: Control group
routine family support
|
routine dementia care manual and family support group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dementia Knowledge Assessment Scale (DKAS)
Time Frame: baseline
|
score of knowledge about dementia
|
baseline
|
|
Dementia Knowledge Assessment Scale (DKAS)
Time Frame: month 3
|
score of knowledge about dementia
|
month 3
|
|
Dementia Knowledge Assessment Scale (DKAS)
Time Frame: month 4
|
score of knowledge about dementia
|
month 4
|
|
Approaches to Dementia Questionnaire (ADQ)
Time Frame: baseline
|
score of attitude toward people with dementia
|
baseline
|
|
Approaches to Dementia Questionnaire (ADQ)
Time Frame: month 3
|
score of attitude toward people with dementia
|
month 3
|
|
Approaches to Dementia Questionnaire (ADQ)
Time Frame: month 4
|
score of attitude toward people with dementia
|
month 4
|
|
Revised Interpersonal Reactivity Index (R-IRI)
Time Frame: baseline
|
empathy toward people with dementia
|
baseline
|
|
Revised Interpersonal Reactivity Index (R-IRI)
Time Frame: month 3
|
empathy toward people with dementia
|
month 3
|
|
Revised Interpersonal Reactivity Index (R-IRI)
Time Frame: month 4
|
empathy toward people with dementia
|
month 4
|
|
Family Caregiver Competence Questionnaire (FACCQ)
Time Frame: baseline
|
score of FACCQ
|
baseline
|
|
Family Caregiver Competence Questionnaire (FACCQ)
Time Frame: month 3
|
score of FACCQ
|
month 3
|
|
Family Caregiver Competence Questionnaire (FACCQ)
Time Frame: month 4
|
score of FACCQ
|
month 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver Burden Inventory (CBI)
Time Frame: baseline
|
score of caregiver burden for caring for people with dementia
|
baseline
|
|
Caregiver Burden Inventory (CBI)
Time Frame: month 3
|
score of caregiver burden for caring for people with dementia
|
month 3
|
|
Caregiver Burden Inventory (CBI)
Time Frame: month 4
|
score of caregiver burden for caring for people with dementia
|
month 4
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YLH-IRB-11104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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