Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

21 maj 2026 uppdaterad av: Myonghwa Park, Chungnam National University

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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

160

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Jung-gu, Daejeon
      • Daejeon, Jung-gu, Daejeon, Sydkorea, 35015
        • Rekrytering
        • College of Nursing, Chungnam National University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: iSupport-Korea Group
Participants will receive access to the iSupport-Korea program for 2 months.
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.
Aktiv komparator: Dementia Information Website Group
Participants will be provided access to publicly available dementia-related informational websites, such as those provided by dementia care centers.
The control condition consists of access to publicly available dementia-related informational websites.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in subjective well-being (CarerQol-VAS)
Tidsram: Baseline, 2 months, and 4 months
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)
Tidsram: Baseline, 2 months, and 4 months
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in caregiver self-efficacy
Tidsram: Baseline, 2 months, and 4 months
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
Tidsram: Baseline, 2 months, and 4 months
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

13 maj 2026

Primärt slutförande (Beräknad)

30 september 2026

Avslutad studie (Beräknad)

4 april 2027

Studieregistreringsdatum

Först inskickad

10 maj 2026

Först inskickad som uppfyllde QC-kriterierna

21 maj 2026

Första postat (Faktisk)

27 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera