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

NCT02397980 | Unknown DMC

• 1 other identifier: EUMC2014-12-028
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Alzheimer's Disease; Dementia

Keywords

Caregivers

Outcome Measures

Primary Outcomes (2)

• Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)

  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)

  Philadelphia Geriatric Center for Moral Scale (PGCMS)

  baseline/10-12 week (after intervention)

Secondary Outcomes (2)

• Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory

  baseline/10-12 week (after intervention)

• Changes in Depression of caregivers as assessed by the geriatric depression scale

  baseline/10-12 week (after intervention)

Study Arms (2)

Control

NO INTERVENTION

Basic information about dementia

Behavioral intervention

ACTIVE COMPARATOR

Individual, 90 min a day, with an interval of 2 weeks * Education about dementia * psychological counselling * cognitive behavioral therapy

Behavioral: Behavioral intervention

Interventions

Behavioral intervention 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

Behavioral intervention

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years 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)

You may not qualify if:

• illiterate
• severe hearing/visual acuity difficulty
• cognitive impairment

Sponsors & Collaborators

• Ewha Womans University Mokdong Hospital: lead

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: March 25, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: March 25, 2015

Record last verified: 2015-03