Effectiveness of a Culturally Adapted Online Education Program (iSupport-Korea) for Family Caregivers of People With Dementia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia
• Intervention / Treatment: Behavioral: iSupport-Korea; Behavioral: Dementia information website

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JINSOL SON; Phone Number: +8242-580-8407; Email: jinsoleei21@gmail.com

Study Locations

• South Korea
  • Jung-gu, Daejeon
    • Daejeon, Jung-gu, Daejeon, South Korea, 35015
      • Recruiting
      • College of Nursing, Chungnam National University
      • Contact: JINSOL SON; Phone Number: +8242-580-8407; Email: jinsoleei21@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iSupport-Korea Group; Participants will receive access to the iSupport-Korea program for 2 months.	Behavioral: 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.
Active Comparator: Dementia Information Website Group; Participants will be provided access to publicly available dementia-related informational websites, such as those provided by dementia care centers.	Behavioral: Dementia information website; The control condition consists of access to publicly available dementia-related informational websites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective well-being (CarerQol-VAS)	Subjective well-being will be measured using the CarerQol-VAS, a visual analogue scale ranging from 0 to 10, with higher scores indicating greater well-being	Baseline, 2 months, and 4 months
Change in care-related quality of life (CarerQol-7D)	Care-related quality of life will be measured using the Carer-related Quality of Life instrument-7 Dimensions (CarerQol-7D), which assesses caregiving burden across seven dimensions. Each dimension is rated on a 3-level scale (no, some, or a lot of problems), with higher scores indicating better care-related quality of life.	Baseline, 2 months, and 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in caregiver self-efficacy	Caregiver self-efficacy will be measured using a modified version of the Caregiver Self-Efficacy Scale (CSES), consisting of 10 items rated on a 0-10 Likert scale, with higher scores indicating greater caregiver self-efficacy.	Baseline, 2 months, and 4 months
Change in family decision-making self-efficacy	Family decision-making self-efficacy will be measured using the 13-item Family Decision-Making Self-Efficacy Scale. Items are rated on a 5-point Likert scale ranging from 1 to 5, with higher scores indicating greater confidence in healthcare-related decision-making.	Baseline, 2 months, and 4 months

Collaborators and Investigators

• Sponsor: Chungnam National University

Study record dates

Study Major Dates

• Study Start (Estimated): May 13, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): April 4, 2027

Study Registration Dates

• First Submitted: May 10, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Caregiver burden; Digital intervention; Dementia caregivers
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Stress, Psychological; Behavior; Caregiver Burden; Dementia
• Other Study ID Numbers: 202601-SB-038-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No