洞察市场格局
解锁药品研发情报

客服电话

400-9696-311

医药数据查询

【ChiCTR1800014521】The Feasibility and Effects of Smartphone-based Application on Cardiac Rehabilitation for Percutaneous Coronary Intervention Patients in Macau

查看原文

立即下载

基本信息

登记号

ChiCTR1800014521

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2018-01-18

临床申请受理号

靶点

适应症

冠心病

试验通俗题目

The Feasibility and Effects of Smartphone-based Application on Cardiac Rehabilitation for Percutaneous Coronary Intervention Patients in Macau

试验专业题目

The Feasibility and Effects of Smartphone-based Application on Cardiac Rehabilitation for Percutaneous Coronary Intervention Patients in Macau

申办单位信息

申请人联系人

请登录查看

申请人名称

请登录查看

联系人邮箱

请登录查看

联系人邮编

联系人通讯地址

请登录查看

临床试验信息

试验目的

The objective of this study is to assess the feasibility and effectiveness of a mHealth application on cardiac rehabilitation (mCR), compared to usual CR care, among percutaneous coronary intervention (PCI) patients on the outcomes of: 1. Anxiety and depression level, by using the Chinese-Cantonese version of the Hospital anxiety and depression scale (HADS); 2. Medication adherence, by using pill count and medication taking record; 3. Exercise capacity, measure by 6-Minute Walk Test (6MWT); 4. Physical activity level, by using International Physical Activity Questionnaire in Chinese version (IPAQ-C); 5. Cardiovascular risk factors modification, including Bp, HR, body mass index (BMI), lipid profile, fasting blood glucose (FBG), HbA1C, smoking status and alcohol intake; 6. Self-efficacy, by the Cardiac Exercise Self-Efficacy Instrument in Chinese version (CESEI-C) and the Cardiac Diet Self-Efficacy Instrument in Chinese version (CDSEI-C); 7. Health-related quality of life (HRQL), by using the Chinese version of Cardiovascular Limitations and Symptoms Profile (C-CLASP); 8. Cardiac-related rehospitalization and Acute & Emergency Department (A&E) visit; and 9. CR App utility and satisfaction.

试验分类

请登录查看

试验类型

随机平行对照

试验分期

治疗新技术

随机化

Permuted-blocked randomization, initiated by sequential numbers with variable block size of 4 in an opaque envelopes, will be conducted by a research assistant at the first week of discharge in the OPD. Participants will be allocated, to two groups: the experiment and control group

盲法

Build the outcome assessors, by research assistants.

试验项目经费来源

Science and Technology Developmental Fundation of Macau (Fundo para o Desenvolvimento das Ciencias e da Tecnologia de Macau)

试验范围

目标入组人数

实际入组人数

第一例入组时间

2017-12-01

试验终止时间

2019-10-18

是否属于一致性

入选标准

1) adult patients aged> 18 years-old with diagnosis of CHD; 2) be treated with PCI; 3) eligible to initiate phase I cardiac rehabilitation (CR) during hospitalization and able to continue phase II CR in Outpatient Department (OPD) rehabilitation centre, and 4) smartphone ownership.；

排除标准

1. Diagnosed with mental or psychiatric disorder; 2. high risk for CR according to American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) stratification guidelines (Research Proposal: Appendix III); 3. having repeated revascularization or Coronary Artery Bypass Graft; 4. significant physical exercise limitations other than heart disease, and 5. post cardiac devices implantation.；

研究者信息

研究负责人姓名

请登录查看

试验机构

香港中文大學

研究负责人电话

请登录查看

研究负责人邮箱

请登录查看

研究负责人邮编

联系人通讯地址

请登录查看