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)

Not Applicable

• Conditions: Adrenergic Beta-Antagonists; Medication Adherence; Mobile Applications; Stable Angina Pectoris

• Registration Number: NCT03794713
• Lead Sponsor: Shenyang Northern Hospital

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.

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Last Update Submitted: 2019-01-03
• Study First Posted: 2019-01-07
• Last Update Posted: 2019-01-07
• Study Start: 2019-04-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

1. Aged 18-70 years;
2. Stable angina pectoris;
3. Indicated for beta blockers;
4. HR ≥ 60bpm;
5. 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;
6. Ability to read, understand and write Chinese;
7. Beta-blockers naïve or with no Beta-blocker use during the last 1 month.

Exclusion Criteria

1. Previous myocardial infarction during the recent 1 year;
2. Cardiac shock or unstable heart failure (NYHA III);
3. SBP<100 mmHg;
4. Sick sinus syndrome;
5. II-III degree atrioventricular block;
6. Existing contraindication for Beta-blockers or allergic to beta-blockers;
7. Participation in another clinical study with a beta blocker during the last 3 months;
8. Inability to sign the informed consent form;
9. Females during pregnancy and lactation and women of child bearing potential planning to be pregnant within 24 weeks.;
10. Patients who withdraw from this study for any reason cannot re-enter the study;
11. Life expectancy < 1 year;
12. Severe asthma or COPD;
13. Severe peripheral vascular disease;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence to beta-blockers	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 Outcome Measures

Name	Time	Method
Impact of resting heart rate	24 weeks	To evaluate the impact of the Patient Support Tool on rHR (resting heart rate).The difference of the average rHR change from baseline between 2 groups.
Impact of angina attacks	24 weeks	To evaluate the impact of the Patient Support Tool on Angina attacks. The difference of the score change of Seattle angina Questionnaire.
Major adverse cardiovascular events	24 weeks	To evaluate the impact of the Patient Support Tool on major adverse cardiovascular events (MACE), a composite of cardiac death, myocardial infarction, stroke, and revascularization.