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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Wen-YU Kuo, PhD
- Número de teléfono: 3411 +886-3-2118999
- Correo electrónico: wykuo@mail.cgust.edu.tw
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Experimental
Participants will receive a 12-month patient-centered digital education and peer support program
|
A 12-month patient-centered digital education and peer support program delivered through LINE communities and Google collaborative platforms.
|
|
Comparador activo: 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.
|
Routine post-stroke care provided by the participating hospital, including standard discharge education and follow-up telephone contacts.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Unmet Needs
Periodo de tiempo: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
Assessed using the Unmet Needs Questionnaire for young stroke survivors
|
Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Self-Efficacy
Periodo de tiempo: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
Assessed using the Chinese version of the Stroke Self-Efficacy Questionnaire
|
Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
|
Depressive Symptoms
Periodo de tiempo: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
Assessed using the Taiwanese Depression Questionnaire
|
Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
|
WHOQOL-BREF Score
Periodo de tiempo: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
Assessed using the Taiwan version of the WHOQOL-BREF.
|
Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
|
Activities of Daily Living
Periodo de tiempo: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
Assessed using the Barthel Index.
|
Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
|
Instrumental Activities of Daily Living
Periodo de tiempo: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
Assessed using the Lawton Instrumental Activities of Daily Living Scale.
|
Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
|
Return-to-Work Status
Periodo de tiempo: 1 month, 3 months, 6 months, and 12 months after enrollment
|
Assessed using a structured return-to-work questionnaire developed for this study.
|
1 month, 3 months, 6 months, and 12 months after enrollment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Wen-Yu Kuo, PhD, Chang Gung University of Science and Technology
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202501542A3
- NSTC 115-2314-B-255-010-MY3 (Otro número de subvención/financiamiento: National Science and Technology Council (NSTC), Taiwan)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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