Clinical trial NCT02397980: Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia
Official title: A Multicenter, Randomized Trial to Assess Efficacy of Therapeutic Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Dementia
Keywords: Caregivers
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)
timeFrame: baseline/10-12 week (after intervention)
measure: Changes in quality of life of caregivers as assessed by Philadelphia Geriatric Center for Moral Scale (PGCMS)
timeFrame: baseline/10-12 week (after intervention)
Secondary outcomes:
measure: Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory
timeFrame: baseline/10-12 week (after intervention)
measure: Changes in Depression of caregivers as assessed by the geriatric depression scale
timeFrame: baseline/10-12 week (after intervention)
Other outcomes:
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