Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia (I-care)

March 24, 2015 updated by: Jeong Jee Hyang, Ewha Womans University Mokdong Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Basic information about dementia
Active Comparator: Behavioral intervention

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

  • Education about dementia
  • psychological counselling
  • cognitive behavioral therapy
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)
Time Frame: baseline/10-12 week (after intervention)
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)
Time Frame: baseline/10-12 week (after intervention)
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
Time Frame: baseline/10-12 week (after intervention)
Neuropsychiatry inventory
baseline/10-12 week (after intervention)
Changes in Depression of caregivers as assessed by the geriatric depression scale
Time Frame: baseline/10-12 week (after intervention)
Geriatric depression scale
baseline/10-12 week (after intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University Mokdong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUMC2014-12-028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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