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)

NCT ID: NCT03794713

Last Updated: 2019-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-09-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Patient support tool

Intervention Type: DEVICE

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenyang Northern Hospital

OTHER

Sponsor Role: lead

Responsible Party

Han Yaling

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jing Li, MD

Role: CONTACT

lijing790126@sina.com

86-024-28897309

Other Identifiers

SUPPORT V1.0

Identifier Type: -

Identifier Source: org_study_id