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临床试验/NCT07609316
NCT07609316招募中不适用

Effectiveness of a Culturally Adapted Online Education Program (iSupport-Korea) for Family Caregivers of People With Dementia: A Randomized Controlled Trial

Chungnam National University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2026年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1

研究概览

简要总结

This randomized controlled trial evaluates the effectiveness of iSupport-Korea, a culturally adapted online education program for family caregivers of people with dementia. A total of 160 caregivers will be randomly assigned to either the intervention or control group and followed for 4 months. The investigators hypothesize that the intervention group will show greater improvements in care-related quality of life, caregiver self-efficacy, and family decision-making self-efficacy.

详细描述

BACKGROUND Dementia is a major public health concern that is rapidly increasing alongside population aging and requires long-term care due to its progressive nature. In Korea, one of the fastest-aging countries in the world, both the prevalence of dementia and the number of family caregivers are continuously increasing.

In the Korean context, family members often serve as the primary caregivers for people with dementia, and they experience multifaceted burdens, including physical fatigue, emotional stress, social isolation, and lack of caregiving skills. These burdens may lead to deterioration in caregivers' health, reduced quality of life for people with dementia, earlier institutionalization, and increased societal costs.

The World Health Organization (WHO) developed iSupport, an evidence-based online education program for family caregivers of people with dementia. However, the program is based on an international standard and may not fully reflect the sociocultural context and caregiving environment in Korea. Therefore, there has been a growing need for cultural adaptation beyond simple translation.

In addition, family caregivers often face limitations in participating in face-to-face education due to the long hours required for caregiving, highlighting the need for accessible digital interventions that can be used regardless of time and place.

STUDY DESIGN This study is a randomized controlled trial with a two-arm parallel-group design. A total of 160 family caregivers of people with dementia will be recruited through dementia care centers. Participants who meet the eligibility criteria and provide informed consent will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Randomization will be performed using a computer-generated random number sequence, with stratification by recruitment site to minimize potential imbalance across centers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 19 years or older
  • Family caregivers currently providing care for a person diagnosed with dementia
  • Informal caregivers such as spouse, children, or relatives
  • Living with the person with dementia or providing regular care even if not cohabiting
  • Able to read and understand Korean and communicate in Korean
  • Able to use digital devices (e.g., smartphone, tablet, or computer) to access an online program
  • Willing to provide informed consent and participate in the study

排除标准

  • Not currently providing direct care to a person with dementia
  • Participating in another dementia caregiver intervention or similar study
  • Having severe cognitive impairment, psychiatric illness, or communication difficulties that limit participation
  • Having severe visual or hearing impairment that interferes with program use
  • Unable to complete follow-up assessments during the study period

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Myonghwa Park

Dean, College of Nursing, Chungnam National University

Chungnam National University

研究点 (1)

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