A Multicenter, Randomized Trial to Assess Efficacy of Therapeutic Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Primary Endpoint
- Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)
Study Overview
Brief Summary
The purpose of this study is to investigate if behavioral intervention for dementia caregivers will decrease caregiver burden in caregivers of patients with dementia. This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS).
Detailed Description
This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The intervention program includes not only the knowledge of dementia and how to manage behavioral problems of patients with dementia but also individual psychological counselling about caregiver's distress. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS). Secondary outcomes are changes in scores of neuropsychiatric inventory and Korean -instrumental Activities of Daily Living of patients as well as depression scores of caregivers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •30-80years old
- •Caregivers who spend their own time with dementia patients over 4 hours a day
- •caregiver distress scores >= 2
- •caregivers of patients in Alzheimer's disease dementia ( mild to moderate stage of dementia, Mini-Mental Status Examination:10~26)
Exclusion Criteria
- •illiterate
- •severe hearing/visual acuity difficulty
- •cognitive impairment
Arms & Interventions
Control
Basic information about dementia
Behavioral intervention
Individual, 90 min a day, with an interval of 2 weeks
- Education about dementia
- psychological counselling
- cognitive behavioral therapy
Intervention: Behavioral intervention (Behavioral)
Outcomes
Primary Outcomes
Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)
Time Frame: baseline/10-12 week (after intervention)
Zaret's Burden Inventory (ZBI)
Changes in quality of life of caregivers as assessed by Philadelphia Geriatric Center for Moral Scale (PGCMS)
Time Frame: baseline/10-12 week (after intervention)
Philadelphia Geriatric Center for Moral Scale (PGCMS)
Secondary Outcomes
- Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory(baseline/10-12 week (after intervention))
- Changes in Depression of caregivers as assessed by the geriatric depression scale(baseline/10-12 week (after intervention))
Investigators
Jeong Jee Hyang
Professor
Ewha Womans University Mokdong Hospital