A Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of a Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia

Conditions
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Dementia Family Caregiver

Intervention / Treatment
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* Other: care empowerment program
* Other: dementia education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two-group cluster randomised controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>care empowerment program | Other: care empowerment program<br>* dementia care e-books, dementia virtual reality activity and family support group<br>|
| Active Comparator: Control group<br>dementia education | Other: dementia education<br>* dementia education manual and family support group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dementia Knowledge Assessment Scale (DKAS) | score of knowledge about dementia | baseline | 
| Dementia Knowledge Assessment Scale (DKAS) | score of knowledge about dementia | month 3 | 
| Dementia Knowledge Assessment Scale (DKAS) | score of knowledge about dementia | month 4 | 
| Approaches to Dementia Questionnaire (ADQ) | score of attitude toward people with dementia | baseline | 
| Approaches to Dementia Questionnaire (ADQ) | score of attitude toward people with dementia | month 3 | 
| Approaches to Dementia Questionnaire (ADQ) | score of attitude toward people with dementia | month 4 | 
| Agitation Management Self-efficacy Scale | score of self-efficacy for managing agitation of people with dementia | baseline | 
| Agitation Management Self-efficacy Scale | score of self-efficacy for managing agitation of people with dementia | month 3 | 
| Agitation Management Self-efficacy Scale | score of self-efficacy for managing agitation of people with dementia | month 4 | 
| Revised Interpersonal Reactivity Index (R-IRI) | empathy toward people with dementia | baseline | 
| Revised Interpersonal Reactivity Index (R-IRI) | empathy toward people with dementia | month 3 | 
| Revised Interpersonal Reactivity Index (R-IRI) | empathy toward people with dementia | month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Burden Inventory (CBI) | score of caregiver burden for caring for people with dementia | baseline | 
| Caregiver Burden Inventory (CBI) | score of caregiver burden for caring for people with dementia | month 3 | 
| Caregiver Burden Inventory (CBI) | score of caregiver burden for caring for people with dementia | month 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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family caregiver, dementia, virtual reality, empowerment