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

N/AActive Not RecruitingNCT07350486

First Hospital of China Medical University6,800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

6,800

Conditions

Hypertension Diabetes Dyslipidemia

Interventions

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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (6)

Cangzhou

Cangzhou, Hebei, China

Wujiang District

Suzhou, Jiangsu, China

Dawa District

Panjin, Liaoning, China

Shenyang

Shenyang, Liaoning, China

Yiwu

Jinzhou, Zhejiang, China

Binhai New Area

Tianjin, China

Outcomes

Primary Outcomes

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).

Time frame: 6 months after baseline

Secondary Outcomes

Net changes in estimated 10-year risk for atherosclerotic CVD.

Net change in estimated 10-year atherosclerotic cardiovascular disease risk.

Time frame: 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.

The proportion of participants achieving target control of each individual risk factor, including blood pressure, HbA1c, and LDL-C.

Time frame: 6 months after baseline

Mean systolic blood pressure changes.

Mean systolic blood pressure changes of participants.

Time frame: 6 months after baseline

Mean diastolic blood pressure changes.

Mean diastolic blood pressure changes of participants.

Time frame: 6 months after baseline.

Mean HbA1c changes.

Mean HbA1c changes of participants.

Time frame: 6 months after baseline.

Mean LDL-C changes.

Mean LDL-C changes of participants.

Time frame: 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.

Time frame: 6 months after baseline

Awareness and treatment rates for hypertension, diabetes, and dyslipidemia.

Rates of disease awareness and treatment for hypertension, diabetes, and dyslipidemia.

Time frame: 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.

Time frame: 6 months after baseline

Mean health expenditures and within-trial cost-utility.

Mean health care expenditures and within-trial cost-utility outcomes.

Time frame: 6 months after baseline

Changes in treatment adherence.

Change in treatment adherence among participants.

Time frame: 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.

Time frame: 6 months after baseline

Patient-reported outcomes related to satisfaction.

Patient-reported satisfaction with LLM will be assessed using a structured scale.

Time frame: 6 months after baseline

Patient-reported outcomes related to self-management.

Patient-reported self-management will be assessed using a structured scale.

Time frame: 6 months after baseline.

Patient-reported outcomes related to quality of life.

Patient-reported quality of life will be assessed using a structured scale.

Time frame: 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.

Time frame: 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.

Time frame: 6 months after baseline