Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients

Not Applicable

Terminated

• Conditions: Coronary Disease
• Interventions: Device: smart phone app; Device: A guideline booklet

• Registration Number: NCT02847078
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

The purpose of the study is to investigate the effects of smart phone app on the secondary prevention for patients with coronary heart disease post percutaneous coronary intervention.

Detailed Description

The secondary prevention for patients with coronary heart disease post percutaneous coronary intervention (PCI) proved associated with a significant reduction in mortality rates and improvement in quality of life. For the limitation of socio-economic conditions, not all patients post PCI are in a position to receive continuous standardized secondary prevention management. Therefore a smart phone app for secondary prevention management post PCI will be installed on patients' smart phones in order to investigate its effects on risk factors control, medication compliance, as well as quality of life and adverse cardiac events in the next six months post discharge. Participants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary heart disease. Patients in app group and control group will be interviewed by telephone at the 2nd week and the 3rd month, and at the 1st month and 6th month they will return our hospital for face to face follow-up and to compliance and medication adjustment, assessment of life quality, risk factors control and medication adherence.

Study Timeline

• Status Verified: 2016-04
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-28
• Study Start: 2016-09-20
• Primary Completion: 2017-04-01
• Study Completion: 2017-05-01
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• First diagnosis of coronary heart disease and received a PCI treatment.
• Age 18-65 years.
• Able and willing to provide written informed consent.

Exclusion Criteria

• Speech communication barriers.
• Patients with a clear history of allergies to anti-platelet drugs.
• Patients with a clear history of allergies to anti-platelet ᵦ-blockers.
• Patients with a clear history of allergies to statin drugs.
• Patients with a clear history of allergies to antihypertensive drugs.
• Patients with a clear history of allergies to antidiabetic drugs.
• Patients with serious heart failure(better than NYHA class II).
• Patients with cerebral infarction or cerebral hemorrhage.
• Patients with liver dysfunction (AST and ALT> 2 times that of the reference value).
• Patients with kidney dysfunction (creatinine clearance rate< 60ml/min).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smart phone app	smart phone app	The app contains education materials for secondary prevention of coronary artery disease. So patients can access them very easily. The app pushes heath management recommendation information on the timeline after percutaneous coronary intervention, and also provides health care lecture to help patients to improve their secondary prevention. And online or telephone consultation ways are integrated into the App to provide convenience for patients to communicate with health care professionals.
Control group	A guideline booklet	Participants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary artery disease.

Primary Outcome Measures

Name	Time	Method
Change in quality of life	Baseline and 1 and 6 months	Seatt1e Angina Questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in medication compliance	Baseline and 1 and 6 months	Percent of prescribed antiplatelet drug，ᵦ-blocker，angiotensin converting enzyme inhibitor，angiotensin II receptor blocker and statins taken during the past 1 and 6 monthers
Change in systolic blood	Baseline and 1 and 6 months	systolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.
Changes in serum triglyceride	Baseline and 1 and 6 months	Serum triglyceride is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
Changes in serum high-density lipoproteincholesterol	Baseline and 1 and 6 months	Serum high-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
Changes in serum total cholesterol	Baseline and 1 and 6 months	Serum total cholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
Change in diastolic blood pressure	Baseline and 1 and 6 months	Diastolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.
Changes in serum low-density lipoproteincholesterol	Baseline and 1 and 6 months	Serum low-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.