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

Dementia Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02397980
• Other study ID #: EUMC2014-12-028
• Status: Not yet recruiting
• Phase: N/A
• First received: March 13, 2015
• Last updated: March 24, 2015
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Ewha Womans University Mokdong Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University Mokdong Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)	Zaret's Burden Inventory (ZBI)	baseline/10-12 week (after intervention)	No
Primary	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)	No
Secondary	Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory	Neuropsychiatry inventory	baseline/10-12 week (after intervention)	No
Secondary	Changes in Depression of caregivers as assessed by the geriatric depression scale	Geriatric depression scale	baseline/10-12 week (after intervention)	No