Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence (MISSION-2)
調査の概要
詳細な説明
The aim of this study is to test the effectiveness of a smartphone based application (APP) on improvement of patients' adherence to medications after coronary artery bypass grafting.
DESIGN AND PROCEDURES The study is a randomized controlled trial, having a plan to recruit 1000 patients underwent coronary artery bypass grafting in 2015, and randomized to either the intervention group or the control group, to test the effectiveness of a smartphone based APP focusing on improving patients medication adherence. Patients randomized to the intervention group install the APP and are intervened by it. The patients randomized to control group receive usual care. The investigators follow up patients in both groups by face to face or telephone interview at 3-month and 6-month after randomization. The 6-month effects of the intervention are evaluated.
The APP contains education materials about secondary prevention of coronary artery disease, patients can surf and read easily. The APP also collects information on medication prescription by doctors, reminds patients at every time of taking medications, and asks for feedback at 8 pm everyday. The APP also pushes one patient-specific questionnaire with 10-15 questions weekly, to collect information about patients' medication adherence and self-administration on blood pressure, blood lipid, glucose, physical activity, diet and body weight. APP will push series of recommendations right after patients' finishing the questionnaire to help them improve secondary prevention.
The coordinators from participating sites interview patients at the baseline, 3-month and 6-month after the randomization, for information of medication adherence, major events and outcomes after coronary artery bypass grafting and quality of life. The primary outcome measure is the Chinese version of the 8-item Morisky medication adherence scale which has already been validated in Chinese population.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Beijing
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Beijing、Beijing、中国、100037
- 募集
- China National Center for Cardiovascular Diseases
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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:
- Underwent coronary artery bypass grafting in 2015
Exclusion Criteria:
- Does not use a smartphone
- Can not install the study specific APP into his/her smartphone
- Does not use 3 or more applications installed in his/her smartphone
- Is incapable to understand texts in Chinese
- Can not type numbers in his/her smartphone
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：対照群
普段のお手入れ
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実験的：Intervention group
APP specific for this study, with reminder, education materials and feedback mechanism for improving secondary medications
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The APP contains education materials about secondary intervention of coronary artery disease, patients can surf and read them very easily.
The APP also collects information on medication prescription by doctors, reminds patients at every time of taking medications, and asks for feedback from patients at 8 pm every day.
The APP also pushes a patient-specific questionnaire with 10-15 questions weekly, to collect information about patients' medication adherence and self-management on blood pressure, blood lipid, blood glucose, physical activity, diet and body weight.
APP pushes series of recommendations right after patients' finishing the questionnaire to help them improve their secondary prevention.
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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 |
|---|---|---|
|
Medication adherence measured by Chinese version of the 8-item Morisky medication adherence scale (C-MMAC-8)
時間枠：6 months
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patients' medication adherence measured by C-MMAC-8 at 6-month after randomization, the scale of more than 7 is defined as adherence to medications
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Medication adherence measured by C-MMAC-8
時間枠：3 month
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patients' medication adherence measured by C-MMAC-8 at 3-month after randomization, the scale of more than 7 is defined as adherence to medications
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3 month
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mortality at 6-month
時間枠：6 months
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6 months
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mortality at 3-month
時間枠：3 months
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3 months
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rate of major adverse cardiovascular or cerebral events at 6-month
時間枠：6 months
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composite endpoint of all-cause death, myocardial infraction, stroke and repeat revascularization
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6 months
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rate of major adverse cardiovascular or cerebral events at 3-month
時間枠：3 months
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composite endpoint of all-cause death, myocardial infraction, stroke and repeat revascularization
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3 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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pill count
時間枠：6 months
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the number of tablets remaining divided by the number of tablets prescribed
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6 months
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pill count
時間枠：3 month
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the number of tablets remaining divided by the number of tablets prescribed
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3 month
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協力者と研究者
捜査官
- スタディディレクター：Shengshou Hu, MD, PhD、State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
- 主任研究者：Zhe Zheng, MD, PhD、State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
出版物と役立つリンク
一般刊行物
- Yan J, You LM, Yang Q, Liu B, Jin S, Zhou J, Lin C, Morisky DE. Translation and validation of a Chinese version of the 8-item Morisky medication adherence scale in myocardial infarction patients. J Eval Clin Pract. 2014 Aug;20(4):311-7. doi: 10.1111/jep.12125. Epub 2014 May 10.
- Yu C, Liu C, Du J, Liu H, Zhang H, Zhao Y, Yang L, Li X, Li J, Wang J, Wang H, Liu Z, Rao C, Zheng Z; MISSION-2 Collaborative Group. Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization. Am Heart J. 2020 Oct;228:17-26. doi: 10.1016/j.ahj.2020.06.019. Epub 2020 Jul 4.
- Liu CY, Du JZ, Rao CF, Zhang H, Liu HN, Zhao Y, Yang LM, Li X, Li J, Wang J, Wang HS, Liu ZG, Cheng ZY, Zheng Z. Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence (MISSION-2). Chin Med J (Engl). 2018 Jun 20;131(12):1480-1489. doi: 10.4103/0366-6999.233767.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
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
本研究に関する用語
キーワード
その他の研究ID番号
- MOST-2013BAI09B01-3
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。
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