AzTrials
AzTrials

DementiaNCT07609316

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

A study testing iSupport-Korea and Dementia information website in people with Dementia, run by Chungnam National University at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Dementia
What is being tested?
iSupport-Korea and Dementia information website
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSouth Korea
Study dates
13 May 2026to 4 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site, 1 recruiting
  • College of Nursing, Chungnam National University

    Daejeon, Jung-gu, Daejeon, 35015

    JINSOL SON, +8242-580-8407, jinsoleei21@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions
Dementia
Being tested
iSupport-Korea, Dementia information website
Keywords
Dementia caregivers, Caregiver burden, Digital intervention, Quality of life
Medical subject headings
Dementia, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iSupport-KoreaBehavioural

    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.

  • Dementia information websiteBehavioural

    The control condition consists of access to publicly available dementia-related informational websites.

Study groups in NCT07609316
Study groupRoleWhat they receive
iSupport-Korea GroupExperimentalParticipants will receive access to the iSupport-Korea program for 2 months.
Receives: Behavioral: iSupport-Korea
Dementia Information Website GroupActive comparatorParticipants will be provided access to publicly available dementia-related informational websites, such as those provided by dementia care centers.
Receives: Behavioral: Dementia information website

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 2 months, and 4 months

  2. 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.

    Measured: Baseline, 2 months, and 4 months

Secondary outcomes (2)
  1. 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.

    Measured: Baseline, 2 months, and 4 months

  2. 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.

    Measured: Baseline, 2 months, and 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start13 May 2026 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion4 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized two-arm trial comparing iSupport-Korea with a dementia information website.
Masking
Single blind
Who is masked
Participant
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07609316
Sponsor's protocol ID
202601-SB-038-01
Status last verified
May 2026
First submitted
10 May 2026
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing iSupport-Korea and Dementia information website in people with Dementia, run by Chungnam National University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JINSOL SON (+8242-580-8407, jinsoleei21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in subjective well-being (CarerQol-VAS) (time frame: Baseline, 2 months, and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in