A Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia
Primary Purpose
Dementia Family Caregiver
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
care empowerment program
dementia education
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia Family Caregiver focused on measuring family caregiver, dementia, virtual reality, empowerment
Eligibility Criteria
Inclusion Criteria:
- age 20 to 90 years,
- Taiwanese nationality,
- have provided care for relatives with dementia or cognitive impairment for at least three months,
- able to read Chinese and communicate in Chinese or Taiwanese,
- 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.
Sites / Locations
- TCUST dementia day centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
care empowerment program
dementia education
Outcomes
Primary Outcome Measures
Dementia Knowledge Assessment Scale (DKAS)
score of knowledge about dementia
Dementia Knowledge Assessment Scale (DKAS)
score of knowledge about dementia
Dementia Knowledge Assessment Scale (DKAS)
score of knowledge about dementia
Approaches to Dementia Questionnaire (ADQ)
score of attitude toward people with dementia
Approaches to Dementia Questionnaire (ADQ)
score of attitude toward people with dementia
Approaches to Dementia Questionnaire (ADQ)
score of attitude toward people with dementia
Agitation Management Self-efficacy Scale
score of self-efficacy for managing agitation of people with dementia
Agitation Management Self-efficacy Scale
score of self-efficacy for managing agitation of people with dementia
Agitation Management Self-efficacy Scale
score of self-efficacy for managing agitation of people with dementia
Revised Interpersonal Reactivity Index (R-IRI)
empathy toward people with dementia
Revised Interpersonal Reactivity Index (R-IRI)
empathy toward people with dementia
Revised Interpersonal Reactivity Index (R-IRI)
empathy toward people with dementia
Secondary Outcome Measures
Caregiver Burden Inventory (CBI)
score of caregiver burden for caring for people with dementia
Caregiver Burden Inventory (CBI)
score of caregiver burden for caring for people with dementia
Caregiver Burden Inventory (CBI)
score of caregiver burden for caring for people with dementia
Full Information
NCT ID
NCT05475002
First Posted
July 18, 2022
Last Updated
October 31, 2022
Sponsor
Tzu Chi University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05475002
Brief Title
A Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia
Official Title
A Randomized Controlled Trial of a Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tzu Chi University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to evaluate a care empowerment program using virtual reality on dementia knowledge, attitude, care self-efficacy, 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 cluster randomised controlled trial aims to evaluate a care empowerment program using virtual reality on dementia knowledge, attitude, care self-efficacy, empathy and caregiver burden of family caregivers of people with dementia.
The family care empowerment program consists of dementia care e-books, dementia virtual reality activity and family support group.
The interventional group will receive the care empowerment program using dementia care e-books, dementia virtual reality activity and family support group.
The control group will only receive dementia education manual and family support group with no dementia virtual reality activity.
Both groups will be assessed for their dementia knowledge, attitudes, care self-efficacy, empathy and caregiver burden at baseline, month 3, and 4.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Family Caregiver
Keywords
family caregiver, dementia, virtual reality, empowerment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two-group cluster randomised controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
care empowerment program
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
dementia education
Intervention Type
Other
Intervention Name(s)
care empowerment program
Intervention Description
dementia care e-books, dementia virtual reality activity and family support group
Intervention Type
Other
Intervention Name(s)
dementia education
Intervention Description
dementia education manual and family support group
Primary Outcome Measure Information:
Title
Dementia Knowledge Assessment Scale (DKAS)
Description
score of knowledge about dementia
Time Frame
baseline
Title
Dementia Knowledge Assessment Scale (DKAS)
Description
score of knowledge about dementia
Time Frame
month 3
Title
Dementia Knowledge Assessment Scale (DKAS)
Description
score of knowledge about dementia
Time Frame
month 4
Title
Approaches to Dementia Questionnaire (ADQ)
Description
score of attitude toward people with dementia
Time Frame
baseline
Title
Approaches to Dementia Questionnaire (ADQ)
Description
score of attitude toward people with dementia
Time Frame
month 3
Title
Approaches to Dementia Questionnaire (ADQ)
Description
score of attitude toward people with dementia
Time Frame
month 4
Title
Agitation Management Self-efficacy Scale
Description
score of self-efficacy for managing agitation of people with dementia
Time Frame
baseline
Title
Agitation Management Self-efficacy Scale
Description
score of self-efficacy for managing agitation of people with dementia
Time Frame
month 3
Title
Agitation Management Self-efficacy Scale
Description
score of self-efficacy for managing agitation of people with dementia
Time Frame
month 4
Title
Revised Interpersonal Reactivity Index (R-IRI)
Description
empathy toward people with dementia
Time Frame
baseline
Title
Revised Interpersonal Reactivity Index (R-IRI)
Description
empathy toward people with dementia
Time Frame
month 3
Title
Revised Interpersonal Reactivity Index (R-IRI)
Description
empathy toward people with dementia
Time Frame
month 4
Secondary Outcome Measure Information:
Title
Caregiver Burden Inventory (CBI)
Description
score of caregiver burden for caring for people with dementia
Time Frame
baseline
Title
Caregiver Burden Inventory (CBI)
Description
score of caregiver burden for caring for people with dementia
Time Frame
month 3
Title
Caregiver Burden Inventory (CBI)
Description
score of caregiver burden for caring for people with dementia
Time Frame
month 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 20 to 90 years,
Taiwanese nationality,
have provided care for relatives with dementia or cognitive impairment for at least three months,
able to read Chinese and communicate in Chinese or Taiwanese,
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huei-Chuan Sung, PhD
Phone
886-952939648
Email
sung@ems.tcust.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-Feng Su, PhD
Phone
886-38572158
Ext
2213
Email
ss205@ems.tcust.edu.tw
Facility Information:
Facility Name
TCUST dementia day center
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Hua Wu, MSc
Phone
886-8572158
Ext
2259
Email
ss460@ems.tcust.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia
We'll reach out to this number within 24 hrs