Effectiveness of a Culturally Adapted Online Education Program (iSupport-Korea) for Family Caregivers of People With Dementia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: iSupport-Korea, Dementia information website.
- Кому может быть актуально
- Состояния в реестре: Dementia. Базовые параметры: от 19 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- South Korea
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effectiveness of a Culturally Adapted Online Education Program (iSupport-Korea) for Family Caregivers of People With Dementia: A Randomized Controlled Trial
Обзор
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.
Подробное описание
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.
INTERVENTION Participants in the intervention group will receive access to the iSupport-Korea online program for 2 months, a self-directed digital intervention covering key aspects of dementia caregiving. The program is delivered via a web-based platform and can be used at the participant's own pace. The control group will access publicly available dementia-related informational websites and continue usual care, with access to iSupport-Korea offered after study completion.
DATA COLLECTION Data will be collected at three time points: baseline (prior to intervention), 2 months (post-intervention), and 4 months (follow-up). All data will be collected using self-administered online questionnaires. Participants will receive secure links to complete the surveys using their personal devices. In cases where online participation is not feasible, alternative arrangements may be provided to facilitate data collection.
STATISTICAL ANALYSIS The effectiveness of the intervention will be evaluated by comparing changes in outcome variables between the intervention and control groups over time. Repeated measures analysis will be conducted to assess the main effects of group and time, as well as group-by-time interaction effects. Additional analyses may be conducted to adjust for baseline differences and to account for missing data where appropriate.
Вмешательства
- Поведенческое iSupport-Korea
iSupport-Korea is a culturally adapted online education and support program for family caregivers of people with dementia. It is designed to enhance caregiver self-efficacy, coping strategies, and overall quality of life through a self-directed learning approach. - Поведенческое Dementia information website
The control condition consists of access to publicly available dementia-related informational websites.
Первичные конечные точки
- Change in subjective well-being (CarerQol-VAS) [Срок оценки: Baseline, 2 months, and 4 months]
- Change in care-related quality of life (CarerQol-7D) [Срок оценки: Baseline, 2 months, and 4 months]
Вторичные конечные точки (2)
- Change in caregiver self-efficacy [Срок оценки: Baseline, 2 months, and 4 months]
- Change in family decision-making self-efficacy [Срок оценки: Baseline, 2 months, and 4 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
South Korea · 1 центр
- College of Nursing, Chungnam National University — Daejeon
Идентификаторы
NCT: NCT07609316 · 202601-SB-038-01