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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
Ewha Womans University Mokdong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer's Disease focused on measuring Caregivers

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 13, 2015
    Last Updated
    March 24, 2015
    Sponsor
    Ewha Womans University Mokdong Hospital
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    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

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

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