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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Beijing
-
Beijing、Beijing、中国、100050
- Beijing Tian Tan Hospital, Capital Medical University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
|
|
プラセボコンパレーター：conventional health education
The second group will receive conventional health education during hospitalization except health education manuals, text message and Digital Video Disc (DVD)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：3 months after stroke onset
|
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.
|
3 months after stroke onset
|
|
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.
時間枠：6 months after stroke onset
|
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.
|
6 months after stroke onset
|
|
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.
時間枠：12 months after stroke onset
|
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.
|
12 months after stroke onset
|
|
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.
時間枠：1 year after stroke onset
|
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.
|
1 year after stroke onset
|
|
Recurrence of ischemic stroke in three months after stroke onset
時間枠：3 months after stroke onset
|
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.
|
3 months after stroke onset
|
|
Recurrence of ischemic stroke in six months after stroke onset
時間枠：6 months after stroke onset
|
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.
|
6 months after stroke onset
|
|
Recurrence of ischemic stroke in 12 months after stroke onset
時間枠：12 months after stroke onset
|
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.
|
12 months after stroke onset
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
clinical prognosis
時間枠：3,6,12 months
|
Death(including Vascular death and non-vascular death); Nonfatal myocardial infarction; Nonfatal hemorrhagic stroke; Severe disabilities(modified Rankin Scale≥4)
|
3,6,12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：yongjun wang, MD、Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。