Co-Designed Digital Education and Peer Support for Young and Middle-Aged Stroke Survivors
A Co-Designed Digital Education and Peer Support Intervention for Reducing Unmet Needs and Enhancing Recovery Among Young and Middle-Aged Stroke Survivors
Stroke survivors often experience persistent unmet needs during long-term recovery. Young and middle-aged stroke survivors may face additional challenges in balancing rehabilitation with work and family responsibilities. Although digital health interventions have the potential to improve access to education and self-management support, existing programs are often provider-driven, provide limited peer support, and have short follow-up periods.
This study aims to evaluate the effectiveness of a patient-centered digital education and peer support intervention co-designed with young and middle-aged stroke survivors. Participants will be randomly assigned to either the intervention group or the usual care group. The intervention will be delivered through LINE communities and Google collaborative platforms over a 12-month period. The primary outcome is unmet needs. Secondary outcomes include stroke self-efficacy, depressive symptoms, quality of life, activities of daily living, instrumental activities of daily living, and return-to-work status.
Přehled studie
Postavení
Detailní popis
Stroke survivors require continuous support to develop healthy lifestyles and self-management behaviors after hospital discharge. However, young and middle-aged stroke survivors often have work and family responsibilities that limit participation in conventional face-to-face education programs. Digital health interventions may improve accessibility and flexibility; however, previous studies have primarily been healthcare provider-led, with limited patient involvement in intervention development, insufficient peer support, relatively short intervention periods, and limited assessment of psychosocial outcomes.
This study consists of two phases. During Phase I, young and middle-aged stroke survivors will participate in a co-design process to develop a patient-centered digital education and peer support intervention. Feedback from a pilot study will be used to refine the intervention before the randomized controlled trial.
During Phase II, eligible participants will be randomly assigned to either the intervention group or the usual care group. Participants in the intervention group will receive a 12-month digital education and peer support program delivered through LINE communities and Google collaborative platforms. The program includes digital educational materials, peer interaction, online meetings, and ongoing support from healthcare professionals. Participants in the control group will receive usual post-stroke care.
Outcome measures will be collected at baseline and at 1, 3, 6, and 12 months after enrollment. The primary outcome is unmet needs. Secondary outcomes include stroke self-efficacy, depressive symptoms, quality of life, activities of daily living, instrumental activities of daily living, and return-to-work status. Longitudinal changes between groups will be analyzed using generalized estimating equations (GEE).
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Wen-YU Kuo, PhD
- Telefonní číslo: 3411 +886-3-2118999
- E-mail: wykuo@mail.cgust.edu.tw
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Aged 31 to 64 years.
- Diagnosis of stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) and physician diagnosis.
- Received treatment at the Stroke Center of Linkou Chang Gung Memorial Hospital.
- Conscious and able to communicate, including individuals with mild aphasia.
- Willing and able to provide informed consent.
Exclusion Criteria:
- End-stage cancer.
- Severe aphasia resulting in inability to communicate.
- Dependent in basic activities of daily living before the index stroke (Barthel Index <100), regardless of the underlying cause.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Experimental
Participants will receive a 12-month patient-centered digital education and peer support program
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A 12-month patient-centered digital education and peer support program delivered through LINE communities and Google collaborative platforms.
|
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Aktivní komparátor: Usual Care
Participants will receive usual post-stroke care, including routine follow-up and telephone contacts, without access to the digital education and peer support program.
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Routine post-stroke care provided by the participating hospital, including standard discharge education and follow-up telephone contacts.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Unmet Needs
Časové okno: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
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Assessed using the Unmet Needs Questionnaire for young stroke survivors
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Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Self-Efficacy
Časové okno: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
Assessed using the Chinese version of the Stroke Self-Efficacy Questionnaire
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Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
|
Depressive Symptoms
Časové okno: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
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Assessed using the Taiwanese Depression Questionnaire
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Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
|
WHOQOL-BREF Score
Časové okno: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
Assessed using the Taiwan version of the WHOQOL-BREF.
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Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
|
Activities of Daily Living
Časové okno: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
Assessed using the Barthel Index.
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Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
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Instrumental Activities of Daily Living
Časové okno: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
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Assessed using the Lawton Instrumental Activities of Daily Living Scale.
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Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
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Return-to-Work Status
Časové okno: 1 month, 3 months, 6 months, and 12 months after enrollment
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Assessed using a structured return-to-work questionnaire developed for this study.
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1 month, 3 months, 6 months, and 12 months after enrollment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Wen-Yu Kuo, PhD, Chang Gung University of Science and Technology
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 202501542A3
- NSTC 115-2314-B-255-010-MY3 (Jiné číslo grantu/financování: National Science and Technology Council (NSTC), Taiwan)
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