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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100050
- Beijing Tian Tan Hospital, Capital Medical University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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.
기간: 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.
기간: 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.
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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clinical prognosis
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: yongjun wang, MD, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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추가 정보
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