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

NCT ID: NCT02397980

Last Updated: 2015-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-12-31

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.

Conditions

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Alzheimer's Disease Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control

Basic information about dementia

Group Type NO_INTERVENTION

No interventions assigned to this group

Behavioral intervention

Individual, 90 min a day, with an interval of 2 weeks

* Education about dementia
* psychological counselling
* cognitive behavioral therapy

Group Type ACTIVE_COMPARATOR

Behavioral intervention

Intervention Type BEHAVIORAL

* 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

Interventions

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Behavioral intervention

* 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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Jee Hyang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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EUMC2014-12-028

Identifier Type: -

Identifier Source: org_study_id

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