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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences | OTHER |
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The goal of this clinical trial is to find out if an artificial intelligence (AI)-enabled stratified management platform can help adults with coronary heart disease (CHD) better perform exercise rehabilitation and manage their health after being discharged from the hospital. The main questions it aims to answer are:
Researchers will compare the AI Management Group (using the platform and a sports wristband) to the Routine Management Group (receiving usual care without the platform) to see if the AI group shows more significant improvements in fitness and health metrics.
Participants will:
The study hopes to show that this intelligent management platform is an effective and safe tool to help people with CHD recover at home, stay active, and reduce future heart risks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-Enabled Stratified Management Group | Experimental | Participants in the intervention group will receive comprehensive post-hospital rehabilitation management through an AI-based stratified management platform, utilizing a smartphone app and wearable device to track health data, deliver reminders and immediate safety alerts. |
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| Standard Post-Discharge Care Group | Active Comparator | Participants in the control group will receive usual discharge protocol and personalized exercise prescription and goals from a specialist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-Enabled Stratified Management System | Combination Product | Following discharge, participants in the AI-stratified management group will use an intelligent platform (smartphone app + wearable divice) for home-based exercise rehabilitation and comprehensive post-discharge care. Key features include: 1) Safety Monitoring & Alerts: Real-time tracking of heart rate and other parameters via wristband triggers immediate safety warnings during exercise; 2) Holistic Risk Management: Integrated support for lifestyle modification, medication adherence, and control of cardiovascular risk factors; 3) Structured Engagement: Multi-channel reminders (messages, alarms, voice calls) for medications, exercise, and follow-ups to sustain adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak oxygen consumption (VO2peak) | Peak oxygen consumption (VO2peak, mL∙kg-¹min-¹) | From enrollment to the end of treatment at 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-minute walk distance | 6-minute walk distance (m) | From enrollment to the end of treatment at 3 months |
| Change in physical activity level (MET-min/week) | Physical activity level (MET-min/week), estimated using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). It consists of 7 questions with a recall period defined as 'last week'. The questions of the scale ask whether the participant walks for at least 10 minutes on any given day or does moderate or vigorous activities, and how much time/day the individual spends on each of these activities or sit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Gao, MD, PhD | Contact | 010-88322413 | sophie_gao@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases | Recruiting | Beijing | Beijing Municipality | 100037 | China |
Individual participant data (IPD) that underlie the results reported in publications will be shared, including all collected de-identified IPD.
Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years thereafter.
De-identified IPD and supporting documents will be made available upon reasonable request to the Principal Investigator (PI). Requests must include a methodologically sound proposal and intended use. Access will be granted at the discretion of the PI after review of the request.
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| Usual post-discharge care | Combination Product | Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies as well as a personalized exercise prescription. |
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| From enrollment to the end of treatment at 3 months |
| Change in average daily step count | Average daily step count (steps per day) | From enrollment to the end of treatment at 3 months |
| Exercise adherence | In the self-reported exercise diary, the participant will note the number of exercises done at home. The percentage adherence to the prescribed exercise regimen was calculated by dividing the number of exercises performed by the number of exercises prescribed and multiplying by 100. | From enrollment to the end of treatment at 3 months. |
| Composite endpoints | A composite endpoint including all-cause mortality, cardiac arrest, non-fatal myocardial infarction, and symptom-driven unplanned rehospitalization occurring during exercise. Safety endpoint during rehabilitation. | From enrollment to the end of treatment at 3 months |
| Systolic blood pressure (mmHg) | Systolic blood pressure. Unit of Measure: mmHg. | From enrollment to the end of treatment at 3 months |
| Diastolic blood pressure (mmHg) | Diastolic blood pressure. Unit of Measure: mmHg. | From enrollment to the end of treatment at 3 months |
| Glycated hemoglobin (HbA1c, %) | Glycated hemoglobin. Unit of Measure: %. | From enrollment to the end of treatment at 3 months |
| Low-density lipoprotein cholesterol (LDL-C, mmol/L) | Unit of Measure: mmol/L | From enrollment to the end of treatment at 3 months |
| Body mass index (BMI, kg/m^2) | From enrollment to the end of treatment at 3 months |
| Unplanned rehospitalization due to cardiovascular causes | From enrollment to the end of treatment at 3 months |
| Major Adverse Cardiovascular Events (MACE) | Major Adverse Cardiovascular Events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. | From enrollment to the end of treatment at 3 months |
| Anxiety level by Generalized Anxiety Disorder-7 scale score | Anxiety level, assessed using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Patients will be evaluated at the beginning and at the endpoint of the study with the self-administered GAD-7 scale. The GAD-7 scale score ranges from 0 to 21 points. A score between 5 and 9 points characterizes mild GAD. Between 10 and 14, moderate GAD and between 15 and 21, severe GAD. | From enrollment to the end of treatment at 3 months |
| Depression level by Patient Health Questionnaire-9 (PHQ-9) | Depression level, assessed using the Patient Health Questionnaire-9 (PHQ-9). The GAD-7 scale score ranges from 0 to 27 points. A score between 5 and 9 points characterizes mild depression. Between 10 and 14, moderate depression; between 15 and 19, moderate-severe depression; and between 20 and 27, severe depression. | From enrollment to the end of treatment at 3 months |
| Sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI) | Sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21 with a higher score indicating poor quality of sleep (worse). The higher the score, the worse the sleep quality. A cut-off score of >5 indicates poor sleep quality. | From enrollment to the end of treatment at 3 months |
| Quality of life by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire | Quality of life, assessed using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire. This questionnaire asks 5 multiple-choice questions about mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. EQ-5D-5L index scores range from 0 to 100, where 100 is the best possible health state. | From enrollment to the end of treatment at 3 months |