- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07609316
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: JINSOL SON
- Numero di telefono: +8242-580-8407
- Email: jinsoleei21@gmail.com
Luoghi di studio
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Jung-gu, Daejeon
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Daejeon, Jung-gu, Daejeon, Corea del Sud, 35015
- Reclutamento
- College of Nursing, Chungnam National University
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Contatto:
- JINSOL SON
- Numero di telefono: +8242-580-8407
- Email: jinsoleei21@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: iSupport-Korea Group
Participants will receive access to the iSupport-Korea program for 2 months.
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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.
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Comparatore attivo: Dementia Information Website Group
Participants will be provided access to publicly available dementia-related informational websites, such as those provided by dementia care centers.
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The control condition consists of access to publicly available dementia-related informational websites.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in subjective well-being (CarerQol-VAS)
Lasso di tempo: Baseline, 2 months, and 4 months
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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
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Baseline, 2 months, and 4 months
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Change in care-related quality of life (CarerQol-7D)
Lasso di tempo: Baseline, 2 months, and 4 months
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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.
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Baseline, 2 months, and 4 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in caregiver self-efficacy
Lasso di tempo: Baseline, 2 months, and 4 months
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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.
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Baseline, 2 months, and 4 months
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Change in family decision-making self-efficacy
Lasso di tempo: Baseline, 2 months, and 4 months
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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.
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Baseline, 2 months, and 4 months
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Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 202601-SB-038-01
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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