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:
- Anxiety and depression level, by using the Chinese-Cantonese version of the Hospital anxiety and depression scale (HADS);
- Medication adherence, by using pill count and medication taking record;
- Exercise capacity, measure by 6-Minute Walk Test (6MWT);
- Physical activity level, by using International Physical Activity Questionnaire in Chinese version (IPAQ-C);
- Cardiovascular risk factors modification, including Bp, HR, body mass index (BMI), lipid profile, fasting blood glucose (FBG), HbA1C, smoking status and alcohol intake;
- 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);
- Health-related quality of life (HRQL), by using the Chinese version of Cardiovascular Limitations and Symptoms Profile (C-CLASP);
- Cardiac-related rehospitalization and Acute & Emergency Department (A&E) visit; and
- 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
研究点 (1)
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