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

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ClinicalTrials.gov Identifier: NCT02397980
Recruitment Status : Unknown
Verified March 2015 by Jeong Jee Hyang, Ewha Womans University Mokdong Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 25, 2015
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
Jeong Jee Hyang, Ewha Womans University Mokdong Hospital

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).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia Behavioral: Behavioral intervention Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive 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 Start Date : March 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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




Primary Outcome Measures :
  1. Changes in Caregiver burden (Zaret's Burden Inventory (ZBI) [ Time Frame: baseline/10-12 week (after intervention) ]
    Zaret's Burden Inventory (ZBI)

  2. 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)


Secondary Outcome Measures :
  1. Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory [ Time Frame: baseline/10-12 week (after intervention) ]
    Neuropsychiatry inventory

  2. Changes in Depression of caregivers as assessed by the geriatric depression scale [ Time Frame: baseline/10-12 week (after intervention) ]
    Geriatric depression scale



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Responsible Party: Jeong Jee Hyang, Professor, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier: NCT02397980     History of Changes
Other Study ID Numbers: EUMC2014-12-028
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by Jeong Jee Hyang, Ewha Womans University Mokdong Hospital:
Caregivers

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders