Clinical trial NCT05475002: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dementia Family Caregiver
Keywords: family caregiver
dementia
virtual reality
empowerment
Lead sponsor: Tzu Chi University of Science and Technology
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-group cluster randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Dementia Knowledge Assessment Scale (DKAS)
timeFrame: baseline
measure: Dementia Knowledge Assessment Scale (DKAS)
timeFrame: month 3
measure: Dementia Knowledge Assessment Scale (DKAS)
timeFrame: month 4
measure: Approaches to Dementia Questionnaire (ADQ)
timeFrame: baseline
measure: Approaches to Dementia Questionnaire (ADQ)
timeFrame: month 3
measure: Approaches to Dementia Questionnaire (ADQ)
timeFrame: month 4
measure: Agitation Management Self-efficacy Scale
timeFrame: baseline
measure: Agitation Management Self-efficacy Scale
timeFrame: month 3
measure: Agitation Management Self-efficacy Scale
timeFrame: month 4
measure: Revised Interpersonal Reactivity Index (R-IRI)
timeFrame: baseline
measure: Revised Interpersonal Reactivity Index (R-IRI)
timeFrame: month 3
measure: Revised Interpersonal Reactivity Index (R-IRI)
timeFrame: month 4
Secondary outcomes:
measure: Caregiver Burden Inventory (CBI)
timeFrame: baseline
measure: Caregiver Burden Inventory (CBI)
timeFrame: month 3
measure: Caregiver Burden Inventory (CBI)
timeFrame: month 4
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: TCUST dementia day center
Study officials:
References: