Skip to content

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)

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03794713
Enrollment
432
Registered
2019-01-07
Start date
2019-04-01
Completion date
2020-09-01
Last updated
2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

beta-blocker, Stable Angina Pectoris, Patient support tool, Adherence

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.

Interventions

DEVICEPatient 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.

Sponsors

Shenyang Northern Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Adherence to beta-blockers24 weeksTo 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

MeasureTime frameDescription
Impact of resting heart rate24 weeksTo 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 attacks24 weeksTo evaluate the impact of the Patient Support Tool on Angina attacks. The difference of the score change of Seattle angina Questionnaire.
Major adverse cardiovascular events24 weeksTo evaluate the impact of the Patient Support Tool on major adverse cardiovascular events (MACE), a composite of cardiac death, myocardial infarction, stroke, and revascularization.

Contacts

Primary ContactJing Li, MD
lijing790126@sina.com86-024-28897309

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026