Effects of a Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients After Coronary Intervention Treatment: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 86
- 主要终点
- Change in quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First diagnosis of coronary heart disease and received a PCI treatment.
- •Age 18-65 years.
- •Able and willing to provide written informed consent.
排除标准
- •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).
结局指标
主要结局
Change in quality of life
时间窗: Baseline and 1 and 6 months
Seatt1e Angina Questionnaire
次要结局
- Change in medication compliance(Baseline and 1 and 6 months)
- Change in systolic blood(Baseline and 1 and 6 months)
- Changes in serum triglyceride(Baseline and 1 and 6 months)
- Changes in serum high-density lipoproteincholesterol(Baseline and 1 and 6 months)
- Changes in serum total cholesterol(Baseline and 1 and 6 months)
- Change in diastolic blood pressure(Baseline and 1 and 6 months)
- Changes in serum low-density lipoproteincholesterol(Baseline and 1 and 6 months)