Medical Large Language Model-Assisted Diagnosis and Treatment in Primary Care Chronic Disease Management

NCT07740044 | Not Yet Recruiting

• 1 other identifier: LSKY 2026-114-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the feasibility of using medical large language models to assist in chronic disease management. By setting up experimental and control group interventions and having experts blindly evaluate anonymized cases, it compares different management approaches in chronic disease care, verifying the scientific basis, effectiveness, and potential for broader use of medical large language models in supporting chronic disease management.

Conditions

Coronary Artery Disease; Atrial Fibrillation (AF); Heart Failure; Stroke

Outcome Measures

Primary Outcomes (1)

• expert overall scores

  A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale on several aspects: accuracy of condition assessment, reasonableness of test recommendations, reasonableness of treatment plans, appropriateness of management choices, scientific nature of patient education content, feasibility at the primary care level, overall clinical quality. Experts were instructed to rank the seven dimensions from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.

  through study completion, an average of 3 months.

Secondary Outcomes (10)

• accuracy of condition assessment

  through study completion, an average of 3 months.

• reasonableness of test recommendations

  through study completion, an average of 3 months.

• reasonableness of treatment plans

  through study completion, an average of 3 months.

• appropriateness of management choices

  through study completion, an average of 3 months.

• scientific nature of patient education content

  through study completion, an average of 3 months.

Study Arms (2)

LLM-Assisted Intervention Group

ACTIVE COMPARATOR

Primary care doctors creating management plans for chronic diseases (coronary heart disease, atrial fibrillation, heart failure, stroke) with the help of large medical language models

Device: Medical large language model

Usual Care Control Group

NO INTERVENTION

Primary care doctors creating management plans for chronic diseases (coronary heart disease, atrial fibrillation, heart failure, stroke) without the help of a large medical language model

Interventions

Medical large language model DEVICE

The primary care physicians in the intervention group completed the management decisions for chronic disease cases, including disease assessment, examination suggestions, treatment plans, selection of management methods, and health education, with the assistance of the medical LLM.

LLM-Assisted Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Work experience of 3 years or more;
• Able to complete the case assessment tasks required by the study;
• Have a practicing doctor qualification;
• Work at a township health center or community health service center;
• Voluntarily participate in the study and sign the informed consent form.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Jiangsu Taizhou People's Hospital: lead

Study Sites (1)

The Affiliated Taizhou People's Hospital of Nanjing Medical University

Taizhou, Jiangsu, 225300, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation; Heart Failure; Stroke

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Guoyu Wang, MD

CONTACT

+8615951154720; wangguoyutzheart@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)