A Cluster-Randomized Trial of Large Language Model-Enabled Coordinated Management for Hypertension, Diabetes, and Dyslipidemia in Community Settings (LLM-CoManage Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,800
- 试验地点
- 7
- 主要终点
- The between-group difference in the proportion of participants achieving simultaneous control of hypertension and either diabetes or dyslipidemia.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
盲法说明
Outcome Assessment Committee members will be blinded to outcome assignment.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •No specific exclusion criteria.
研究组 & 干预措施
LLM-Enabled Intervention Group
LLM-enabled community physicians delivered integrated, guideline-based management
干预措施: LLM-Enabled Co-management (Other)
Usual Care Control Group
Community physicians provided routine care according to local primary health service standards
结局指标
主要结局
The between-group difference in the proportion of participants achieving simultaneous control of hypertension and either diabetes or dyslipidemia.
时间窗: 6 months after baseline
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).
次要结局
- Changes in treatment adherence.(6 months after baseline)
- Improvements in behavioral risk factors (e.g., diet, physical activity, tobacco use, lifestyle intervention uptake).(6 months after baseline)
- Patient-reported outcomes related to satisfaction.(6 months after baseline)
- Net changes in estimated 10-year risk for atherosclerotic CVD.(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.(6 months after baseline)
- Mean systolic blood pressure changes.(6 months after baseline)
- Mean diastolic blood pressure changes.(6 months after baseline.)
- Mean HbA1c changes.(6 months after baseline.)
- Mean LDL-C changes.(6 months after baseline.)
- Proportion of participants achieving simultaneous control of BP, HbA1c, and LDL-C.(6 months after baseline)
- Awareness and treatment rates for hypertension, diabetes, and dyslipidemia.(6 months after baseline)
- Proportion of participants receiving integrated, guideline-based management of all indicated conditions.(6 months after baseline)
- Mean health expenditures and within-trial cost-utility.(6 months after baseline)
- Patient-reported outcomes related to self-management.(6 months after baseline.)
- Patient-reported outcomes related to quality of life.(6 months after baseline.)
- Adoption and utilization of the LLM system by physicians and patients.(6 months after baseline)
- Patterns of AI-assisted recommendations and digital interactions.(6 months after baseline)
研究者
Yingxian Sun
Chief of Department of Cardiology in First Hospital of China Medical University
First Hospital of China Medical University