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

Ewha Womans University logo

Ewha Womans University

Status

Unknown

Conditions

Alzheimer's Disease
Dementia

Treatments

Behavioral: Behavioral intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02397980
EUMC2014-12-028

Details and patient eligibility

About

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).

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

80 participants in 2 patient groups

Control
No Intervention group
Description:
Basic information about dementia
Behavioral intervention
Active Comparator group
Description:
Individual, 90 min a day, with an interval of 2 weeks * Education about dementia * psychological counselling * cognitive behavioral therapy
Treatment:
Behavioral: Behavioral intervention

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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