"Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Coronary Artery Bypass Graft Patients or Post Percutaneous Coronary Intervention Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 536
- 试验地点
- 1
- 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-CABG (coronary artery bypass grafting) patients or post-PCI (percutaneous coronary intervention) patients. A randomized controlled trial design will be used, involving approximately 5-10 hospitals and 536 participants. Eligible participants are adults aged 18 or older, 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •History of CABG surgery or PCI with history of 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
- •Use of a smartphone.
- •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.
研究组 & 干预措施
"Smart family doctor" assisted management plus health managers
"Smart family doctor", an AI-assisted applications with personalized interactions and 3-hour health management guidance from a health manager once a week.
干预措施: Smart family doctor (Behavioral)
"Smart family doctor" assisted management plus health managers
"Smart family doctor", an AI-assisted applications with personalized interactions and 3-hour health management guidance from a health manager once a week.
干预措施: Health manager (Behavioral)
Usual care: health managers
3-hour health management guidance from a health manager once a week.
干预措施: Health manager (Behavioral)
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.
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)
- Smoking Rate(6-month)
- Total cholesterol(6-month)
- HDL-C(6-month)
- Triglycerides(6-month)
- Small dense LDL-C(6-month)
- Lipoprotein (a)(6-month)
- Fasting blood glucose(6-month)
- HbA1c(6-month)
- Physical Activity Level(6-month)
- Coronary artery disease-related quality of life(6-month)
- Psychological status(6-month)
- Cognitive function(6-month)
- HbA1c(6-month)
- Blood Pressure Control Rate(6-month)
- Triglycerides(6-month)
- Small dense LDL-C(6-month)
- Lipoprotein (a)(6-month)
- Fasting blood glucose(6-month)
- Physical Activity Level(6-month)
- Quality of life using the Short Form Health Survey (SF-12v2)(6-month)
- Coronary artery disease-related quality of life(6-month)
- Psychological status(6-month)
- Smoking Rate(6-month)
- Total cholesterol(6-month)
- LDL-C(6-month)
- HDL-C(6-month)
- Cognitive function(6-month)
研究者
Xin Yuan
Professor
China National Center for Cardiovascular Diseases