Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia (I-care)
Primary Purpose
Alzheimer's Disease, Dementia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavioral intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Disease focused on measuring 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Behavioral intervention
Arm Description
Basic information about dementia
Individual, 90 min a day, with an interval of 2 weeks Education about dementia psychological counselling cognitive behavioral therapy
Outcomes
Primary Outcome Measures
Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)
Zaret's Burden Inventory (ZBI)
Changes in quality of life of caregivers as assessed by Philadelphia Geriatric Center for Moral Scale (PGCMS)
Philadelphia Geriatric Center for Moral Scale (PGCMS)
Secondary Outcome Measures
Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory
Neuropsychiatry inventory
Changes in Depression of caregivers as assessed by the geriatric depression scale
Geriatric depression scale
Full Information
NCT ID
NCT02397980
First Posted
March 13, 2015
Last Updated
March 24, 2015
Sponsor
Ewha Womans University Mokdong Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02397980
Brief Title
Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia
Acronym
I-care
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University Mokdong Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia
Keywords
Caregivers
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Basic information about dementia
Arm Title
Behavioral intervention
Arm Type
Active Comparator
Arm Description
Individual, 90 min a day, with an interval of 2 weeks
Education about dementia
psychological counselling
cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
Behavioral intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)
Description
Zaret's Burden Inventory (ZBI)
Time Frame
baseline/10-12 week (after intervention)
Title
Changes in quality of life of caregivers as assessed by Philadelphia Geriatric Center for Moral Scale (PGCMS)
Description
Philadelphia Geriatric Center for Moral Scale (PGCMS)
Time Frame
baseline/10-12 week (after intervention)
Secondary Outcome Measure Information:
Title
Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory
Description
Neuropsychiatry inventory
Time Frame
baseline/10-12 week (after intervention)
Title
Changes in Depression of caregivers as assessed by the geriatric depression scale
Description
Geriatric depression scale
Time Frame
baseline/10-12 week (after intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia
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