"Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Revascularization Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 951
- 主要终点
- The control rates of hypertension, diabetes and hyperlipidemia
研究概览
简要总结
This study aims to evaluate the effect of an AI-assisted "Smart family doctor" digital health management tool on improving the control rates of hypertension, diabetes, and dyslipidemia in post-revascularization patients. A randomized controlled trial design will be used, involving approximately 10-20 hospitals and 951 participants. Eligible participants are adults aged between 18 and 80 years, post-CABG or post-PCI patients with hypertension, diabetes, and dyslipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Data manager and statistician.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years.
- •Underwent CABG or PCI more than 3 months prior and have concurrent hypertension, diabetes, and dyslipidemia.
- •At least one of the following criteria is meet:
- •Systolic blood pressure no less than 130 mmHg or diastolic blood pressure no less than 80 mmHg
- •HbA1c no less than 7%
- •LDL-C no less than 1.4 mmol/L
- •Signed informed consent.
排除标准
- •History of heart failure or severe arrhythmias.
- •Presence of other severe underlying conditions such as cancer or liver and kidney insufficiency.
- •Pregnancy, lactation, or plans for pregnancy within the next year.
- •Cognitive, communication impairments, or limitations in daily activities.
- •Unable to use smartphone.
结局指标
主要结局
The control rates of hypertension, diabetes and hyperlipidemia
时间窗: 6-month
All cretria are meet: 1) Systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg. 2) HbA1c less than 7%. 3) LDL-C less than 1.4 mmol/L.
次要结局
- Blood Pressure Control Rate(6-month)
- Blood lipid Control Rate(6-month)
- Triglycerides(6-month)
- Blood Pressure Control Rate(6-month)
- Blood glucose Control Rate(6-month)
- Blood lipid Control Rate(6-month)
- Systolic blood pressure(6-month)
- Diastolic blood pressure(6-month)
- Fasting blood glucose(6-month)
- HbA1c(6-month)
- Total cholesterol(6-month)
- LDL-C(6-month)
- HDL-C(6-month)
- Triglycerides(6-month)
- Medication adherence (4-item Morisky Medication-Taking Adherence Scale)(6-month)
- Coronary artery disease-related quality of life (the Seattle Angina Questionnaire)(6-month)
- Smoking Rate(6-month)
研究者
Xin Yuan
Professor
China National Center for Cardiovascular Diseases