LLM-CoManage: Large Language Model-Enabled Co-Management of Hypertension, Diabetes, and Dyslipidemia

A Cluster-Randomized Trial of Large Language Model-Enabled Coordinated Management for Hypertension, Diabetes, and Dyslipidemia in Community Settings (LLM-CoManage Trial)

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.

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 exclusion criteria.