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临床试验/NCT03059784
NCT03059784Unknown不适用

Mobile Application-based Multifaceted Management to Improve Long-term Care After Percutaneous Coronary Intervention

Chinese Academy of Medical Sciences, Fuwai Hospital0 个研究点目标入组 1,100 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
1,100
主要终点
evidence-based medication adherence (the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications)

研究概览

简要总结

High rates of recurrent cardiovascular events and readmission after percutaneous coronary intervention (PCI) are important issues. Guidelines emphasize rehabilitation and secondary prevention. But many patients are lack of effective management after PCI.This study is aimed to examine the effect of mobile application (APP)-based multifaceted management on the improvement of long-term care after PCI.

详细描述

This is a cluster-randomized controlled trial to evaluate the effect of APP-based multifaceted management strategy on improvement of long-term care for medication adherence,risk factor control, and reduction of adverse events, readmission rate and mortality after PCI.It includes knowledge education, medication reminder,advice provision, support to change lifestyle behaviors. The program is interactive between care provider and patients. A total of 20 wards will be randomly assigned to intervention or usual care.Anticipated 1100 patients after PCI will be participated in the trial. All the participants will be followed up until 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •patients who have received percutaneous coronary intervention and are discharged alive in the study centers;
  • •patients who are able to use APP;
  • •patients who provide informed consent.

排除标准

  • •patients who are not able to use APP;
  • •dementia;
  • •mental disturbed;
  • •patients who are not willing to receive management and follow up.

研究组 & 干预措施

control

No Intervention

usual care without APP

intervention

Experimental

APP-based multifaceted management, including sending education material, everyday medication reminder, giving risk factor control support, clinical support to patients after PCI through APP.

干预措施: APP-based multifaceted management (Other)

结局指标

主要结局

evidence-based medication adherence (the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications)

时间窗: at 12 months after PCI

the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications

次要结局

  • rate of systolic blood pressure achieving target(at 12 months after PCI)
  • readmission rate(12 months after PCI)
  • rate of LDL-C achieving target(at 12 months after PCI)

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yongjian Wu

Associate director of Coronary Artery Disease Center

Chinese Academy of Medical Sciences, Fuwai Hospital

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