Secondary Prevention of Coronary Heart Disease
Conditions
Keywords
Coronary heart disease, secondary prevention, mobile health, artificial intelligence
Brief summary
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: 1. Does the AI-enhanced app help lower bad cholesterol (LDL-C) levels within 3 months after leaving the hospital? 2. 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: 1. Be randomly assigned to use either the AI-enhanced app or receive usual care. 2. Use the app to track and manage their health, receive reminders, and get educational tips. 3. 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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTAIM-CHD Mobile Health Intervention
The AIM-CHD platform synchronizes data from hospitalization records, questionnaires, AI-powered voice follow-ups, and wearable devices to perform risk stratification and manage uncontrolled risk factors. It provides individualized follow-up plans, medication reminders, and lifestyle education, with real-time assessments of vital health metrics to prompt necessary in-person consultations. The app offers online consultation access and emergency services through Fuwai Hospital. Additionally, it delivers personalized patient education, aligning with the latest clinical guidelines.
COMBINATION_PRODUCTUsual post-discharge care
Usual post-discharge care includes oral and written instructions on sustained pharmacotherapy regimens, recommended follow-up frequency, and lifestyle modifications.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* severe cognitive impairment * advanced malignant tumors * expected survival of less than 3 months * severe multi-organ failure * refusal to sign the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C levels | measured at 3 months post-discharge. | LDL-C levels (mmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C Target Attainment Rate | assessed at 3 months post-discharge | Proportion of patients achieving LDL-C \<1.8 mmol/L |
| Blood Pressure Control Rate | assessed at 3 months post-discharge | Proportion of patients with controlled blood pressure, defined as systolic pressure \<130 mmHg and diastolic pressure \<80 mmHg. |
| Glycosylated Hemoglobin Levels | assessed at 3 months post-discharge | — |
| Smoking Rate | assessed at 3 months post-discharge | Proportion of patients who are still smoking |
| Cardiovascular Composite Endpoint Events | assessed at 3 months post-discharge | Incidence of all-cause mortality, non-fatal myocardial infarction, stroke, and rehospitalization. |
| Medication Adherence | assessed at 3 months post-discharge | Proportion of patients adhering to antiplatelet agents and statins, defined as taking medications for more than 80% of the prescribed time over the past month. |
| BMI | assessed at 3 months post-discharge | body mass index |
Countries
China
Outcome results
None listed