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| Name | Class |
|---|---|
| Beijing Chao Yang Hospital | OTHER |
| Zhejiang University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Cangzhou Central Hospital |
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This study aims to evaluate the effectiveness of a large language model (LLM)-supported, community-based integrated management model in improving cardiometabolic multimorbidity control among adults with hypertension and coexisting diabetes or dyslipidemia. Adopting an interventional study design, eligible patients will be recruited to compare the disease control indicators between LLM-assisted management and conventional management, so as to verify the effectiveness and safety of the former.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LLM-Enabled Intervention Group | Active Comparator | LLM-enabled community physicians delivered integrated, guideline-based management |
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| Usual Care Control Group | No Intervention | Community physicians provided routine care according to local primary health service standards |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LLM-Enabled Co-management | Other | The intervention is a LLM-enabled, community-based integrated management strategy for cardiometabolic multimorbidity. The LLM system functions as the central intelligence layer, integrating multi-condition clinical information, delivering real-time decision support, coordinating care workflows, and facilitating continuous patient engagement. Within this LLM-enabled framework, community physicians-after standardized training-serve as the core executors of care, delivering guideline-based pharmacologic treatment, lifestyle counseling, and structured monitoring of coexisting cardiometabolic conditions. Policy-aligned performance incentives are used to support physician engagement and implementation fidelity, without altering medication access or underlying clinical protocols. The LLM-enabled intervention is implemented through the HyperMind system, an integrated platform that simultaneously supports clinicians, patients, and health-system oversight. |
| Measure | Description | Time Frame |
|---|---|---|
| The between-group difference in the proportion of participants achieving simultaneous control of hypertension and either diabetes or dyslipidemia. | Simultaneous control is defined as BP < 130/80 mmHg and at least one of the following: HbA1c < 7.0% or LDL-C < 2.6 mmol/L (100 mg/dL), with a stricter threshold of < 1.8 mmol/L (70 mg/dL) for participants with cardiovascular disease(CVD). | 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Net changes in estimated 10-year risk for atherosclerotic CVD. | Net change in estimated 10-year atherosclerotic cardiovascular disease risk. | 6 months after baseline |
| Proportion of participants achieving control of individual risk factors: BP < 130/80 mmHg (or < 140/90 mmHg); HbA1c < 7.0%; and LDL-C < 2.6 mmol/L (100 mg/dL) or < 1.8 mmol/L (70 mg/dL) for those with CVD. |
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Inclusion Criteria:
Participating communities must meet all of the following criteria:
Eligible participants must fulfill all of the following conditions:
Exclusion Criteria:No specific exclusion criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofan Guo, PhD | Contact | +86 13842078178 | guoxiaofan1986@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yingxian Sun, MD, PhD | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| OTHER |
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Outcome Assessment Committee members will be blinded to outcome assignment.
|
The proportion of participants achieving target control of each individual risk factor, including blood pressure, HbA1c, and LDL-C. |
| 6 months after baseline |
| Mean systolic blood pressure changes. | Mean systolic blood pressure changes of participants. | 6 months after baseline |
| Mean diastolic blood pressure changes. | Mean diastolic blood pressure changes of participants. | 6 months after baseline. |
| Mean HbA1c changes. | Mean HbA1c changes of participants. | 6 months after baseline. |
| Mean LDL-C changes. | Mean LDL-C changes of participants. | 6 months after baseline. |
| Proportion of participants achieving simultaneous control of BP, HbA1c, and LDL-C. | The proportion of participants achieving simultaneous control of blood pressure, HbA1c, and LDL-C. | 6 months after baseline |
| Awareness and treatment rates for hypertension, diabetes, and dyslipidemia. | Rates of disease awareness and treatment for hypertension, diabetes, and dyslipidemia. | 6 months after baseline |
| Proportion of participants receiving integrated, guideline-based management of all indicated conditions. | The proportion of participants receiving integrated, guideline-based management for indicated conditions. | 6 months after baseline |
| Mean health expenditures and within-trial cost-utility. | Mean health care expenditures and within-trial cost-utility outcomes. | 6 months after baseline |
| Changes in treatment adherence. | Change in treatment adherence among participants. | 6 months after baseline |
| Improvements in behavioral risk factors (e.g., diet, physical activity, tobacco use, lifestyle intervention uptake). | Changes in behavioral risk factors including diet, physical activity, and tobacco use. | 6 months after baseline |
| Patient-reported outcomes related to satisfaction. | Patient-reported satisfaction with LLM will be assessed using a structured scale. | 6 months after baseline |
| Patient-reported outcomes related to self-management. | Patient-reported self-management will be assessed using a structured scale. | 6 months after baseline. |
| Patient-reported outcomes related to quality of life. | Patient-reported quality of life will be assessed using a structured scale. | 6 months after baseline. |
| Adoption and utilization of the LLM system by physicians and patients. | The extent of physician and patient adoption and use of the LLM-based system. | 6 months after baseline |
| Patterns of AI-assisted recommendations and digital interactions. | The patterns of Artificial Intelligence(AI)-assisted recommendations and related digital interactions generated during the study. | 6 months after baseline |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |