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Not yet recruiting NCT07350486

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

No phase Interventional Hypertension Diabetes Dyslipidemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LLM-Enabled Co-management.
Who it may be relevant to
Registry conditions: Hypertension, Diabetes, Dyslipidemia. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • Other LLM-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 pharmaco

Primary outcome measures

  • The between-group difference in the proportion of participants achieving simultaneous control of hypertension and either diabetes or dyslipidemia. [Time frame: 6 months after baseline]
Secondary outcome measures (12)
  • Net changes in estimated 10-year risk for atherosclerotic CVD. [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. [Time frame: 6 months after baseline]
  • Mean systolic blood pressure changes. [Time frame: 6 months after baseline]
  • Mean diastolic blood pressure changes. [Time frame: 6 months after baseline.]
  • Mean HbA1c changes. [Time frame: 6 months after baseline.]
  • Mean LDL-C changes. [Time frame: 6 months after baseline.]
  • Proportion of participants achieving simultaneous control of BP, HbA1c, and LDL-C. [Time frame: 6 months after baseline]
  • Awareness and treatment rates for hypertension, diabetes, and dyslipidemia. [Time frame: 6 months after baseline]
  • Proportion of participants receiving integrated, guideline-based management of all indicated conditions. [Time frame: 6 months after baseline]
  • Mean health expenditures and within-trial cost-utility. [Time frame: 6 months after baseline]
  • Changes in treatment adherence. [Time frame: 6 months after baseline]
  • Improvements in behavioral risk factors (e.g., diet, physical activity, tobacco use, lifestyle intervention uptake). [Time frame: 6 months after baseline]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Hospital of China Medical University — Shenyang

Identifiers

NCT: NCT07350486 · CMU-HyperMindRCT-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗