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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Randomized Trial to Assess Efficacy of Therapeutic Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia

Conditions
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Dementia, Alzheimer's Disease

Intervention / Treatment
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* Behavioral: Behavioral intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Basic information about dementia | |
| Active Comparator: Behavioral intervention<br>Individual, 90 min a day, with an interval of 2 weeks Education about dementia psychological counselling cognitive behavioral therapy | Behavioral: Behavioral intervention<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Caregiver burden (Zaret's Burden Inventory (ZBI) | Zaret's Burden Inventory (ZBI) | baseline/10-12 week (after intervention) | 
| Changes in quality of life of caregivers as assessed by Philadelphia Geriatric Center for Moral Scale (PGCMS) | Philadelphia Geriatric Center for Moral Scale (PGCMS) | baseline/10-12 week (after intervention) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers