Diabetes, Dyslipidemia, Hypertension
Conditions
Keywords
Large Language Model, Co-Management
Brief summary
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.
Interventions
OTHERLLM-Enabled Co-management
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.
Sponsors
First Hospital of China Medical University
Beijing Chao Yang Hospital
Zhejiang University
Shandong Provincial Hospital
Cangzhou Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Outcome Assessment Committee members will be blinded to outcome assignment.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participating communities must meet all of the following criteria: * Have a designated community physician responsible for primary care who is capable of using a smartphone with stable internet access for clinical communication and LLM-assisted management; * No plan for administrative merger or restructuring within the next three years; * Located at least 2 kilometers away from adjacent participating communities (to minimize contamination between clusters). Eligible participants must fulfill all of the following conditions: * Aged 40 years or older; * Uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg; * Coexisting diabetes (HbA1c ≥ 7.0%) or coexisting dyslipidemia (LDL-C ≥ 3.4 mmol/L\[130 mg/dL\]); * Able to use a smartphone independently or with assistance from family members; * Has resided in the participating community for at least 6 months; * Has no plan to relocate in the next 3 years; * Enrolled in basic medical insurance for urban and rural residents, employee medical insurance, or the New Rural Cooperative Medical Scheme; * Not currently pregnant or planning pregnancy during the study period; * Free from malignant tumors and deemed to have a life expectancy of at least 3 years, as judged by study physicians; * Willing and able to provide written informed consent.
Exclusion criteria
No specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The between-group difference in the proportion of participants achieving simultaneous control of hypertension and either diabetes or dyslipidemia. | 6 months after baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Net changes in estimated 10-year risk for atherosclerotic CVD. | 6 months after baseline | Net change in estimated 10-year atherosclerotic cardiovascular disease risk. |
| 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. | 6 months after baseline | The proportion of participants achieving target control of each individual risk factor, including blood pressure, HbA1c, and LDL-C. |
| Mean systolic blood pressure changes. | 6 months after baseline | Mean systolic blood pressure changes of participants. |
| Mean diastolic blood pressure changes. | 6 months after baseline. | Mean diastolic blood pressure changes of participants. |
| Mean HbA1c changes. | 6 months after baseline. | Mean HbA1c changes of participants. |
| Mean LDL-C changes. | 6 months after baseline. | Mean LDL-C changes of participants. |
| Proportion of participants achieving simultaneous control of BP, HbA1c, and LDL-C. | 6 months after baseline | The proportion of participants achieving simultaneous control of blood pressure, HbA1c, and LDL-C. |
| Awareness and treatment rates for hypertension, diabetes, and dyslipidemia. | 6 months after baseline | Rates of disease awareness and treatment for hypertension, diabetes, and dyslipidemia. |
| Proportion of participants receiving integrated, guideline-based management of all indicated conditions. | 6 months after baseline | The proportion of participants receiving integrated, guideline-based management for indicated conditions. |
| Mean health expenditures and within-trial cost-utility. | 6 months after baseline | Mean health care expenditures and within-trial cost-utility outcomes. |
| Changes in treatment adherence. | 6 months after baseline | Change in treatment adherence among participants. |
| Improvements in behavioral risk factors (e.g., diet, physical activity, tobacco use, lifestyle intervention uptake). | 6 months after baseline | Changes in behavioral risk factors including diet, physical activity, and tobacco use. |
| Patient-reported outcomes related to satisfaction. | 6 months after baseline | Patient-reported satisfaction with LLM will be assessed using a structured scale. |
| Patient-reported outcomes related to self-management. | 6 months after baseline. | Patient-reported self-management will be assessed using a structured scale. |
| Patient-reported outcomes related to quality of life. | 6 months after baseline. | Patient-reported quality of life will be assessed using a structured scale. |
| Patterns of AI-assisted recommendations and digital interactions. | 6 months after baseline | The patterns of Artificial Intelligence(AI)-assisted recommendations and related digital interactions generated during the study. |
| Adoption and utilization of the LLM system by physicians and patients. | 6 months after baseline | The extent of physician and patient adoption and use of the LLM-based system. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYingxian Sun, MD, PhD
First Hospital of China Medical University
Outcome results
None listed