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Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence (MISSION-2)

2015年6月21日 更新者：China National Center for Cardiovascular Diseases
The study is a randomized controlled trial, having a plan to recruit 1000 patients underwent coronary artery bypass grafting in 1 of 5 participating sites in 2015, and randomized to either the intervention group or control group, to test the effectiveness of a smartphone based application (APP) focusing on improving patients medication adherence. Patients randomized to the intervention group install the APP in their smartphones with personnel information and physicians' medication descriptions. The APP reminds at the time of taking medications, educates them on secondary prevention for coronary artery disease, and collects their weekly situations by questionaires. Investigators will follow-up patients by face to face or telephone interview. The 6-month effects of the intervention are evaluated.

研究概览

地位

未知

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (预期的)

1000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Beijing
      • Beijing、Beijing、中国、100037
        • 招聘中
        • China National Center for Cardiovascular Diseases

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：控制组
日常护理
实验性的：Intervention group
APP specific for this study, with reminder, education materials and feedback mechanism for improving secondary medications
行为的：APP intervention
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.

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
Medication adherence measured by Chinese version of the 8-item Morisky medication adherence scale (C-MMAC-8)
大体时间：6 months
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
6 months

次要结果测量

结果测量
措施说明
大体时间
Medication adherence measured by C-MMAC-8
大体时间：3 month
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
3 month
mortality at 6-month
大体时间：6 months
6 months
mortality at 3-month
大体时间：3 months
3 months
rate of major adverse cardiovascular or cerebral events at 6-month
大体时间：6 months
composite endpoint of all-cause death, myocardial infraction, stroke and repeat revascularization
6 months
rate of major adverse cardiovascular or cerebral events at 3-month
大体时间：3 months
composite endpoint of all-cause death, myocardial infraction, stroke and repeat revascularization
3 months

其他结果措施

结果测量
措施说明
大体时间
pill count
大体时间：6 months
the number of tablets remaining divided by the number of tablets prescribed
6 months
pill count
大体时间：3 month
the number of tablets remaining divided by the number of tablets prescribed
3 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

China National Center for Cardiovascular Diseases

调查人员

  • 研究主任：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
  • 首席研究员：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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年6月1日

初级完成 (预期的)

2015年12月1日

研究完成 (预期的)

2016年12月1日

研究注册日期

首次提交

2015年4月25日

首先提交符合 QC 标准的

2015年5月1日

首次发布 (估计)

2015年5月4日

研究记录更新

最后更新发布 (估计)

2015年6月23日

上次提交的符合 QC 标准的更新

2015年6月21日

最后验证

2015年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • MOST-2013BAI09B01-3

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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