A Randomized, Two-arm, Open Label Study to evalUate the Effect of a Smart Phone-based Patient Support Tool On Patient AdheRence of Treatment in Stable Angina Patients Prescribed Beta-blockers in China (SUPPORT)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 432
- 主要终点
- Adherence to beta-blockers
研究概览
简要总结
The present study aims to enhance the adherence of beta-blockers by Patient Support Tool through a smart phone application and a wristband, subsequently reduce the risk of angina attacks in patients with stable angina pectoris.
详细描述
To control heart rate in terms of guidelines in patients with stable angina pectoris reduces risk of cardiovascular events, rehospitalization, and death effectively. Using beta blockers is an efficient therapy to management the HR in SAP patients. However, the recent epidemiological studies have provided evidences that the rate of beta blocker prescribed and used was inadequate, as the first-line therapy to CAD patients with the usage rate less than 30%. Several studies showed that with a reminder supported by smart phones and wearable devices, the adherence of management of patients with chronic disease could be improved significantly.Thus,the present study aims to enhance the adherence of beta-blockers by Patient Support Tool through a smart phone application and a wristband, subsequently reduce the risk of angina attacks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years;
- •Stable angina pectoris;
- •Indicated for beta blockers;
- •HR ≥ 60bpm;
- •Patient must have a smart phone that is compatible with the Patient support tool at their disposal and are comfortable with using of interactive smart phone applications. The required specification for the phone will be determined after completed testing;
- •Ability to read, understand and write Chinese;
- •Beta-blockers naïve or with no Beta-blocker use during the last 1 month.
排除标准
- •Previous myocardial infarction during the recent 1 year;
- •Cardiac shock or unstable heart failure (NYHA III);
- •SBP<100 mmHg;
- •Sick sinus syndrome;
- •II-III degree atrioventricular block;
- •Existing contraindication for Beta-blockers or allergic to beta-blockers;
- •Participation in another clinical study with a beta blocker during the last 3 months;
- •Inability to sign the informed consent form;
- •Females during pregnancy and lactation and women of child bearing potential planning to be pregnant within 24 weeks.;
- •Patients who withdraw from this study for any reason cannot re-enter the study;
- •Life expectancy < 1 year;
- •Severe asthma or COPD;
- •Severe peripheral vascular disease;
研究组 & 干预措施
Patient support tool group
Subjects were managed the HR by using the Patient Support Tool through a smart phone application and a wristband and be guided by physicians
干预措施: Patient support tool (Device)
Control group
Subjects were received a usual patient care at baseline, which left to the discretion of physicians, without any specific intervention at follow-up period
结局指标
主要结局
Adherence to beta-blockers
时间窗: 24 weeks
To evaluate the effect of Patient Support Tool through a smart phone application and a wristband on adherence to beta-blockers in patients with stable coronary artery disease.Duration of treatment-defined as the days the Patient has taken beta-blockers followed the advice of doctors during the 24-week follow up.
次要结局
- Impact of angina attacks(24 weeks)
- Major adverse cardiovascular events(24 weeks)
- Impact of resting heart rate(24 weeks)
研究者
Han Yaling
Dr
Shenyang Northern Hospital