A Co-Designed Digital Education and Peer Support Intervention for Reducing Unmet Needs and Enhancing Recovery Among Young and Middle-Aged Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 148
- 主要终点
- Unmet Needs
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants are informed that they will receive one of two post-stroke education programs but are not informed which program is the intervention. Research staff delivering the interventions and outcome assessors are blinded to treatment allocation.
入排标准
- 年龄范围
- 31 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Unmet Needs
时间窗: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Assessed using the Unmet Needs Questionnaire for young stroke survivors
次要结局
- Self-Efficacy(Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment)
- Depressive Symptoms(Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment)
- WHOQOL-BREF Score(Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment)
- Activities of Daily Living(Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment)
- Instrumental Activities of Daily Living(Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment)
- Return-to-Work Status(1 month, 3 months, 6 months, and 12 months after enrollment)