Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia

Not Applicable

• Conditions: Alzheimer's Disease; Dementia
• Interventions: Behavioral: Behavioral intervention

• Registration Number: NCT02397980
• Lead Sponsor: Ewha Womans University Mokdong Hospital

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 Timeline

• Status Verified: 2015-03
• Study Start: 2015-03
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-24
• Last Update Submitted: 2015-03-24
• Study First Posted: 2015-03-25
• Last Update Posted: 2015-03-25
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

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Exclusion Criteria

• illiterate
• severe hearing/visual acuity difficulty
• cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Behavioral intervention	Behavioral intervention	Individual, 90 min a day, with an interval of 2 weeks * Education about dementia * psychological counselling * cognitive behavioral therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in Depression of caregivers as assessed by the geriatric depression scale	baseline/10-12 week (after intervention)	Geriatric depression scale
Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory	baseline/10-12 week (after intervention)	Neuropsychiatry inventory