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

China Medical University

Status: Begins enrollment in 4 months

Conditions: Hypertension; Diabetes; Dyslipidemia

Treatments: Other: LLM-Enabled Clinician-Patient Co-management

Study type: Interventional

Funder types: Other

Identifiers

NCT07350486

CMU-HyperMindRCT-2025

Details and patient eligibility

About

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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6,000 participants in 2 patient groups

LLM-Enabled Intervention Group

Active Comparator group

Description:

LLM-enabled community physicians delivered integrated, guideline-based management

Treatment:

Other: LLM-Enabled Clinician-Patient Co-management

Usual Care Control Group

No Intervention group

Description:

Community physicians provided routine care according to local primary health service standards