Alzheimer's Disease, Dementia
Conditions
Keywords
Caregivers
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.
Interventions
BEHAVIORALBehavioral intervention
* What the dementia is * How to deal with behavioral problems in patients with dementia * How to manage caregiver's stress * How to care dementic patients as well as caregivers themselves
Sponsors
Ewha Womans University Mokdong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Caregiver burden (Zaret's Burden Inventory (ZBI) | 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) | baseline/10-12 week (after intervention) | Philadelphia Geriatric Center for Moral Scale (PGCMS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory | baseline/10-12 week (after intervention) | Neuropsychiatry inventory |
| Changes in Depression of caregivers as assessed by the geriatric depression scale | baseline/10-12 week (after intervention) | Geriatric depression scale |
Outcome results
None listed