跳至主要内容
临床试验/ChiCTR1800014521
ChiCTR1800014521尚未招募Unknown

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

Science and Technology Developmental Fundation of Macau (Fundo para o Desenvolvimento das Ciencias e da Tecnologia de Macau)1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年12月1日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
HADS

研究概览

简要总结

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.

研究设计

研究类型
Interventional
主要目的
随机平行对照
盲法
Build the outcome assessors, by research assistants.

入排标准

年龄范围
18 至 99(—)
性别
All

入选标准

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

排除标准

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

研究组 & 干预措施

mCR App Group

mCR App

Control group

usual care

结局指标

主要结局

HADS

次要结局

  • Medication adherence
  • 6-Minute Walk Test (6MWT)
  • IPAQ-C
  • Bp, HR, body mass index (BMI), lipid profile, fasting blood glucose (FBG), HbA1C, smoking status and alcohol intake;
  • CESEI-C & CDSEI-C
  • C-CLASP
  • Cardiac-related rehospitalization and Acute & Emergency Department (A&E) visit
  • App utility and satisfaction

研究者

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

研究点 (1)

Loading locations...

相似试验