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)

Medication Adherence Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03794713
• Other study ID #: SUPPORT V1.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: January 2019
• Source: Shenyang Northern Hospital
• Contact: Jing Li, MD
• Phone: 86-024-28897309
• Email: lijing790126[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 432
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Adrenergic Beta-Antagonists
• Angina Pectoris
• Angina, Stable
• Medication Adherence
• Mobile Applications
• Stable Angina Pectoris

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to beta-blockers	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.	24 weeks
Secondary	Impact of resting heart rate	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.	24 weeks
Secondary	Impact of angina attacks	To evaluate the impact of the Patient Support Tool on Angina attacks. The difference of the score change of Seattle angina Questionnaire.	24 weeks
Secondary	Major adverse cardiovascular events	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.	24 weeks