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)

Sponsor

Shenyang Northern Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03794713

Collaborator

(none)

432

Enrollment

Arms

17.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adrenergic Beta-Antagonists Stable Angina Pectoris Medication Adherence Mobile Applications	Device: Patient support tool	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

432 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: Patient support tool The patient support tool, a software app installed on the smart phones plus a wrist connected to the smart phones by Bluetooth. The wrist could monitor the pulse, which was recorded to the app in the smart phone. Meanwhile, the app could inform to patients about the importance of medication, remind on the medicine intake, share the patients' data with themselves, and warn the patients if the wrist don't wear.
No Intervention: 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

Arm

Intervention/Treatment

Experimental: 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

Device: Patient support tool

The patient support tool, a software app installed on the smart phones plus a wrist connected to the smart phones by Bluetooth. The wrist could monitor the pulse, which was recorded to the app in the smart phone. Meanwhile, the app could inform to patients about the importance of medication, remind on the medicine intake, share the patients' data with themselves, and warn the patients if the wrist don't wear.

No Intervention: 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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;
Life expectancy < 1 year;
Severe asthma or COPD;
Severe peripheral vascular disease;