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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adrenergic Beta-Antagonists
- Sponsor
- Shenyang Northern Hospital
- Enrollment
- 432
- Primary Endpoint
- Adherence to beta-blockers
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Han Yaling
Dr
Shenyang Northern Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Adherence to beta-blockers
Time Frame: 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.
Secondary Outcomes
- Impact of angina attacks(24 weeks)
- Major adverse cardiovascular events(24 weeks)
- Impact of resting heart rate(24 weeks)