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)

Shenyang Northern Hospital

Status: Unknown

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

Treatments: Device: Patient support tool

Study type: Interventional

Funder types: Other

Identifiers

NCT03794713

SUPPORT V1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 432 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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432 participants in 2 patient groups

Patient support tool group

Experimental group

Description:

Subjects were managed the HR by using the Patient Support Tool through a smart phone application and a wristband and be guided by physicians

Treatment:

Device: Patient support tool

Control group

No Intervention group

Description:

Subjects were received a usual patient care at baseline, which left to the discretion of physicians, without any specific intervention at follow-up period