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【ChiCTR-INR-16009598】基于智能手机的家庭心脏康复和冠心病患者二级预防的随机对照研究

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基本信息

登记号

ChiCTR-INR-16009598

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2016-10-25

临床申请受理号

靶点

适应症

冠心病

试验通俗题目

基于智能手机的家庭心脏康复和冠心病患者二级预防的随机对照研究

试验专业题目

基于智能手机的家庭心脏康复和冠心病患者二级预防的随机对照研究

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

The aim of the clinical trial is to assess the effects of smartphone-based cardiac rehabilitation and secondary prevention program on the short-term and long-term outcomes of post-PCI CHD patients, as well as its effects on improvement of quality of life, enhancing management of risk factors and medication, increasing cost benefits and reducing hospital readmissions.

试验分类

试验类型

随机平行对照

试验分期

治疗新技术

随机化

The Project Manager will be supplied with one randomization envelope for each participant. It is the responsibility of the Project Manager to ensure that these randomization envelopes are safely stored, but readily available to the relevant staff. Once patients have signed the Consent Form, they will provided with a

盲法

试验项目经费来源

Curtin University PhD research funding

试验范围

目标入组人数

300

实际入组人数

第一例入组时间

2016-05-06

试验终止时间

2019-05-05

是否属于一致性

入选标准

Eligible participants will be patients diagnosed with coronary heart disease and received PCI. Inclusion criteria are that the participant must: Diagnosed by a clinician, have met criteria for diagnosis of CHD; Received PCI therapy during this admission; Aged between 18-70 years; Have an active smartphone, and have sufficient Chinese language proficiency to reading, speaking and listening; Able to operate smartphone for the purposes of trial; Living with at least one caregiver or guardian in the household; Presence of normal hemodynamics with a resting ejection fraction ≥ 50%; Able to individually consent; Not participating in any other clinical trial.；

排除标准

Unable to be involved in clinical follow up and treatment; Unable to operate smartphone for the purpose of the trial (eg, vision, hearing, cognitive or dexterity impairment); Had no experience with WeChat application; Have no internet connection at residence and smartphone Wi-Fi connection; Have contra-indication to CR.；

研究者信息

研究负责人姓名

试验机构

Curtin University

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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