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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients After Coronary Intervention Treatment: a Randomized Controlled Trial

Conditions
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Coronary Disease

Intervention / Treatment
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* Device: smart phone app
* Device: A guideline booklet


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart phone app<br>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. | Device: smart phone app<br>* App for this study is provided with real time updating educational materials, reminder, and consultation for improving secondary prevention, and the related information is pushed to a patient in chronological order after his or her PCI operation.<br>|
| Other: Control group<br>Participants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary artery disease. | Device: A guideline booklet<br>* A guideline booklet with general advice on secondary prevention of coronary artery disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | Seatt1e Angina Questionnaire | Baseline and 1 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in medication compliance | 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 | Baseline and 1 and 6 months | 
| Change in systolic blood | systolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg. | Baseline and 1 and 6 months | 
| Change in diastolic blood pressure | Diastolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg. | Baseline and 1 and 6 months | 
| Changes in serum total cholesterol | Serum total cholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L. | Baseline and 1 and 6 months | 
| Changes in serum triglyceride | Serum triglyceride is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L. | Baseline and 1 and 6 months | 
| Changes in serum high-density lipoproteincholesterol | Serum high-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L. | Baseline and 1 and 6 months | 
| Changes in serum low-density lipoproteincholesterol | Serum low-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L. | Baseline and 1 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Disease, percutaneous coronary intervention, secondary prevention, smart phone app