The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
NCT Number: NCT07350486
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.
Trial opening soon.
Get Notified40 year and older
All sexes
Interventional
Not applicable
Shenyang, Liaoning, 110001, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participating communities must meet all of the following criteria:
Eligible participants must fulfill all of the following conditions:
Exclusion criteria
No specific exclusion criteria.
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.
Time frame: 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).
Time frame: 6 months after baseline
Net change in estimated 10-year atherosclerotic cardiovascular disease risk.
Time frame: 6 months after baseline
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 of participants.
Time frame: 6 months after baseline.
Mean diastolic blood pressure changes of participants.
Time frame: 6 months after baseline.
Mean HbA1c changes of participants.
Time frame: 6 months after baseline.
Mean LDL-C changes of participants.
Time frame: 6 months after baseline
The proportion of participants achieving simultaneous control of blood pressure, HbA1c, and LDL-C.
Time frame: 6 months after baseline
Rates of disease awareness and treatment for hypertension, diabetes, and dyslipidemia.
Time frame: 6 months after baseline
The proportion of participants receiving integrated, guideline-based management for indicated conditions.
Time frame: 6 months after baseline
Mean health care expenditures and within-trial cost-utility outcomes.
Time frame: 6 months after baseline
Change in treatment adherence among participants.
Time frame: 6 months after baseline
Changes in behavioral risk factors including diet, physical activity, and tobacco use.
Time frame: 6 months after baseline
Patient-reported satisfaction with LLM will be assessed using a structured scale.
Time frame: 6 months after baseline.
Patient-reported self-management will be assessed using a structured scale.
Time frame: 6 months after baseline.
Patient-reported quality of life will be assessed using a structured scale.
Time frame: 6 months after baseline
The extent of physician and patient adoption and use of the LLM-based system.
Time frame: 6 months after baseline
The patterns of Artificial Intelligence(AI)-assisted recommendations and related digital interactions generated during the study.
Contact information is provided by the study sponsor or research team.
First Hospital of China Medical University
Other
A Cluster-Randomized Trial of Large Language Model-Enabled Coordinated Management for Hypertension, Diabetes, and Dyslipidemia in Community Settings (LLM-CoManage Trial)
Acronym: LLM-CoManage
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07679828
Cardiovascular Diseases, Diabetes
Chifeng, Inner Mongolia, China
View Trial DetailsNCT07654231
Arterial Occlusive Diseases, Arteriosclerosis
Dallas, Texas, United States
View Trial DetailsNCT07340580
Behavior, Body Weight
Greenville, South Carolina, United States
View Trial DetailsNCT06879639
Arthritis, Cardiovascular Diseases
Vila Nova de Famalicão, Braga District, Portugal
View Trial Details