Clinical trial NCT03794713: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adrenergic Beta-Antagonists
Stable Angina Pectoris
Medication Adherence
Mobile Applications
Keywords: beta-blocker
Stable Angina Pectoris
Patient support tool
Adherence
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Adherence to beta-blockers
timeFrame: 24 weeks
Secondary outcomes:
measure: Impact of resting heart rate
timeFrame: 24 weeks
measure: Impact of angina attacks
timeFrame: 24 weeks
measure: Major adverse cardiovascular events
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
References: