NCT07609316

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
May 2026Apr 2027

First Submitted

Initial submission to the registry

May 10, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2027

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 10, 2026

Last Update Submit

May 21, 2026

Conditions

Dementia

Keywords

Dementia caregiversCaregiver burdenDigital interventionQuality of life

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change in caregiver self-efficacy

    Baseline, 2 months, and 4 months

  • Change in family decision-making self-efficacy

    Baseline, 2 months, and 4 months

Study Arms (2)

iSupport-Korea Group

EXPERIMENTAL

Participants will receive access to the iSupport-Korea program for 2 months.

Behavioral: iSupport-Korea

Dementia Information Website Group

ACTIVE COMPARATOR

Participants will be provided access to publicly available dementia-related informational websites, such as those provided by dementia care centers.

Behavioral: Dementia information website

Interventions

iSupport-KoreaBEHAVIORAL

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.

iSupport-Korea Group
Dementia information websiteBEHAVIORAL

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

Dementia Information Website Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Nursing, Chungnam National University

Daejeon, Jung-gu, Daejeon, 35015, South Korea

RECRUITING

MeSH Terms

Conditions

DementiaCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

JINSOL SON

CONTACT

+8242-580-8407jinsoleei21@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized two-arm trial comparing iSupport-Korea with a dementia information website.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean, College of Nursing, Chungnam National University

Study Record Dates

First Submitted

May 10, 2026

First Posted

May 27, 2026

Study Start

May 13, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

April 4, 2027

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)