- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07740044
Medical Large Language Model-Assisted Diagnosis and Treatment in Primary Care Chronic Disease Management
2026년 7월 27일 업데이트: Jiangsu Taizhou People's Hospital
Verification and Application Study of Medical Large Language Model-Assisted Diagnosis and Treatment in Primary Care Chronic Disease Management: A Randomized Controlled Study
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.
연구 개요
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Guoyu Wang, MD
- 전화번호: +8615951154720
- 이메일: wangguoyutzheart@163.com
연구 장소
-
-
Jiangsu
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Taizhou, Jiangsu, 중국, 225300
- The Affiliated Taizhou People's Hospital of Nanjing Medical University
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연락하다:
- Guoyu Wang, MD
- 전화번호: +8615951154720
- 이메일: wangguoyutzheart@163.com
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
N/A
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: LLM-Assisted Intervention Group
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
|
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.
|
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간섭 없음: Usual Care Control Group
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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
expert overall scores
기간: through study completion, an average of 3 months.
|
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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
accuracy of condition assessment
기간: through study completion, an average of 3 months.
|
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 accuracy of condition assessment 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.
|
|
reasonableness of test recommendations
기간: through study completion, an average of 3 months.
|
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 regarding the reasonableness of test recommendations.
Experts were instructed to rank the dimension 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.
|
|
reasonableness of treatment plans
기간: through study completion, an average of 3 months.
|
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 regarding the reasonableness of treatment plans.
Experts were instructed to rank the dimension 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.
|
|
appropriateness of management choices
기간: through study completion, an average of 3 months.
|
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 regarding the ppropriateness of management choices.
Experts were instructed to rank the dimension 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.
|
|
scientific nature of patient education content
기간: through study completion, an average of 3 months.
|
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 regarding the scientific nature of patient education content.
Experts were instructed to rank the dimension 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.
|
|
feasibility at the primary care level
기간: through study completion, an average of 3 months.
|
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 regarding the feasibility at the primary care level.
Experts were instructed to rank the dimension 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.
|
|
the overall clinical quality
기간: through study completion, an average of 3 months.
|
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 regarding the overall clinical quality.
Experts were instructed to rank the dimension 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.
|
|
risk advice
기간: through study completion, an average of 3 months.
|
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.
If there is no risk advice, the expert selects 'No'; otherwise, the expert selects 'Yes' and specifically lists the content of the risk advice.
|
through study completion, an average of 3 months.
|
|
Any diagnostic or treatment information missing
기간: through study completion, an average of 3 months.
|
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.
If there is no omission of diagnostic and treatment information, the expert selects "No"; otherwise, the expert selects "Yes" and specifically lists the omitted diagnostic and treatment content.
|
through study completion, an average of 3 months.
|
|
feedback regarding the use of medical LLM by primary care physicians
기간: through study completion, an average of 3 months.
|
After primary care physicians complete a case assessment assisted by medical LLM , they will fill out an evaluation of the medical LLM usage, including whether the medical LLM helped in disease assessment, assisted in formulating examination plans, aided in developing treatment plans, improved chronic disease management capabilities, supported chronic disease education, assisted in management approach selection, enhanced confidence, saved time, whether there were hallucinations or omissions, whether it provided risky suggestions, and any additional comments on the use of the medical LLM.
|
through study completion, an average of 3 months.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 17일
기본 완료 (추정된)
2026년 9월 30일
연구 완료 (추정된)
2026년 11월 30일
연구 등록 날짜
최초 제출
2026년 7월 20일
QC 기준을 충족하는 최초 제출
2026년 7월 27일
처음 게시됨 (실제)
2026년 7월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 27일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .