Affect of Multiple Health Education on Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients
Affect of Multiple Health Education Interventions on Secondary Prevention Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients: a Prospective Cohort Study
研究概览
详细说明
The study is a prospective, multicenter, hospital-based study on secondary prevention for patients with ischemic cerebrovascular diseases between May 2014 and June 2015. Physicians from 24 hospitals in Beijing underwent a standard secondary prevention training of ischemic cerebrovascular diseases by professional training, instruction manuals, stratification management software. In order to improve the persistence of taking preventive secondary medicine, IS patients from these 24 hospitals received healthy education through manuals and Digital Video Disc about health education during hospitalization and acquired secondary preventive knowledge of ischemic cerebrovascular diseases through regular health education messages during 6 months after discharge. Patients with IS from other 6 hospitals were used as a control, and no such intervention was given to them.
Telephone follow-up was performed at 3 months, 6 months, and 1 year after the onset of cerebral infarction, during which the use of antiplatelet and statins drugs and recurrence of IS were recorded. Patients who took antiplatelet drugs or statins at three follow-ups were regarded as persistent antiplatelet drugs or statins taking within one year after the onset of the disease. The main prognostic indicator was the recurrence of IS and persistence of antiplatelet and statins medication within 1 year, and the main purpose was to explore the impact of persistent statins and antiplatelet medication use on IS recurrence.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国、100050
- Beijing Tian Tan Hospital, Capital Medical University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult subjects (male or female ≥18 years);
- Acute ischemic stroke occured within 14 days of symptoms onset
- Patients signed informed consent
- Patients have a cell phone and have the ability to receive and view messages
Exclusion Criteria:
- Non-cerebrovascular events or hemorrhagic stroke
- Patients have serious heart, liver, kidney dysfunction or coagulation disorders
- Patients have circumstances that may affect the follow-up such as disturbance of consciousness, severe depression or other mental disorders, aphasia
- Modified Rankin Scale score at discharge ≥3
- Those who are participating in other clinical trials
- Those who can not guarantee with the completion of 1 year follow-up after enrollment
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：multiple health education interventions
The group will receive health education manuals and Digital Video Disc (DVD) during hospitalization and regular text message during 1 year after discharge.
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安慰剂比较：conventional health education
The second group will receive conventional health education during hospitalization except health education manuals, text message and Digital Video Disc (DVD)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of patients who continued taking antiplatelet drugs at three months after stroke onset, and proportion of patients who continued taking statins drugs at three months after stroke onset.
大体时间：3 months after stroke onset
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Medication persistence at 3 months.
Persistence is defined as continuing a therapy or class of therapy from discharge to the 3 months follow-up.
Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent".
Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
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3 months after stroke onset
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Proportion of patients who continued taking antiplatelet drugs at six months after stroke onset, and proportion of patients who continued taking statins drugs at six months after stroke onset.
大体时间：6 months after stroke onset
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Medication persistence at 6 months.
Persistence at 6 months is defined as continuing a therapy or class of therapy at 6 months follow-up.
Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent".
Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
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6 months after stroke onset
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Proportion of patients who continued taking antiplatelet drugs at 12 months after stroke onset, and proportion of patients who continued taking statins drugs at 12 months after stroke onset.
大体时间：12 months after stroke onset
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Medication persistence at 12 months.
Persistence at 12 months is defined as continuing a therapy or class of therapy at 12 months follow-up.
Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent".
Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
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12 months after stroke onset
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Proportion of patients who continued taking antiplatelet drugs in 1 year after stroke onset, and proportion of patients who continued taking statins drugs in 1 year after stroke onset.
大体时间：1 year after stroke onset
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Patients who took statins and antiplatelet medications at 3, 6 and 12 months follow-up were regarded as persistent during one year after stroke onset.
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1 year after stroke onset
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Recurrence of ischemic stroke in three months after stroke onset
大体时间：3 months after stroke onset
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Recurrence of IS was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
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3 months after stroke onset
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Recurrence of ischemic stroke in six months after stroke onset
大体时间：6 months after stroke onset
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Recurrence of IS was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
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6 months after stroke onset
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Recurrence of ischemic stroke in 12 months after stroke onset
大体时间：12 months after stroke onset
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Recurrence of IS was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
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12 months after stroke onset
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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clinical prognosis
大体时间：3,6,12 months
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Death(including Vascular death and non-vascular death); Nonfatal myocardial infarction; Nonfatal hemorrhagic stroke; Severe disabilities(modified Rankin Scale≥4)
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3,6,12 months
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合作者和调查者
赞助
调查人员
- 首席研究员：yongjun wang, MD、Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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