A Single-Center, Open-Label, Randomized, Parallel Controlled Trial Evaluating the Effectiveness of Artificial Intelligence-Enhanced Management for Coronary Heart Disease (AIM-CHD) Delivered Via Mobile Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,100
- 试验地点
- 2
- 主要终点
- LDL-C levels
研究概览
简要总结
The goal of this clinical trial is to find out if an artificial intelligence (AI)-enhanced mobile app can help people with coronary heart disease (CHD) better manage their health after being discharged from the hospital. The main questions it aims to answer are:
- Does the AI-enhanced app help lower bad cholesterol (LDL-C) levels within 3 months after leaving the hospital?
- Does the app improve other health measures, like blood pressure, blood sugar control, weight, medication adherence and cardiac events?
Researchers will compare the AI-enhanced app to usual care, where participants receive usual health advice without using the app.
Participants will:
- Be randomly assigned to use either the AI-enhanced app or receive usual care.
- Use the app to track and manage their health, receive reminders, and get educational tips.
- Attend checkups at 3 months to measure cholesterol levels and other health outcomes.
The study hopes to show that using an AI-enhanced app can make it easier for people with CHD to stay healthy and avoid future heart problems.
详细描述
The AIM-CHD app was developed by a diverse team at Fuwai Hospital, including doctors, nurses, patients, and software engineers. It gathers information from synchronized hospital records, questionnaires, intelligent voice follow-ups, and wearable devices. Using this data, it categorizes patients by risk level, detects unmanaged risk factors, and generates individualized follow-up schedules and intervention plans. When risk factors are not well controlled, the app alerts patients to these issues. It also reminds users to monitor their health markers regularly, follow prescribed medication routines, and offers personalized health education focused on lifestyle adjustments. The app can assess the severity of blood pressure, heart rate, blood glucose, and lipid levels, advising patients to seek in-person consultations if necessary. AIM-CHD also recognizes emergency scenarios and provides options for online consultations or immediate help from Fuwai Hospital to prevent treatment delays. The platform leverages artificial intelligence (AI) for efficient lab report image recognition and speech-to-text conversion, streamlining follow-up care. Additionally, it offers customized patient education. The AIM-CHD's intervention goals and strategies are grounded in the latest clinical guidelines. The system is built with a front-end and back-end separation architecture: the back-end is developed with the .NET framework using C#, while the front-end is a WeChat mini-program created with JavaScript and React.
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
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHD patients aged 18-85 years
- •ability of the patient or close relatives to use smartphones and applications
- •willingness to participate and sign the informed consent form
排除标准
- •severe cognitive impairment
- •advanced malignant tumors
- •expected survival of less than 3 months
- •severe multi-organ failure
- •refusal to sign the informed consent form
结局指标
主要结局
LDL-C levels
时间窗: measured at 3 months post-discharge.
LDL-C levels (mmol/L)
次要结局
- LDL-C Target Attainment Rate(assessed at 3 months post-discharge)
- Blood Pressure Control Rate(assessed at 3 months post-discharge)
- Glycosylated Hemoglobin Levels(assessed at 3 months post-discharge)
- Smoking Rate(assessed at 3 months post-discharge)
- BMI(assessed at 3 months post-discharge)
- Cardiovascular Composite Endpoint Events(assessed at 3 months post-discharge)
- Medication Adherence(assessed at 3 months post-discharge)