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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• The between-group difference in the proportion of participants achieving simultaneous control of hypertension and either diabetes or dyslipidemia. [Срок оценки: 6 months after baseline]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Hospital of China Medical University — Шэньян

Идентификаторы

NCT: NCT07350486 · CMU-HyperMindRCT-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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