跳至主要内容
临床试验/NCT06893068
NCT06893068招募中不适用

Evaluation of a Multimodal Model-Based Clinical Intelligent Management System: A Pragmatic Randomized Controlled Trial

Tsinghua University1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2025年4月13日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
204
试验地点
1
主要终点
Comprehensive Assessment of clinical performance

研究概览

简要总结

This study aims to evaluate the effectiveness of a clinical intelligent management system, based on a multimodal foundational model, in improving the quality of primary care at a community health service center.

Using a prospective, randomized controlled, single-blind study design, the trial will include primary care physicians and adult patients seeking care at the Tiantongyuanbei Community Health Service Center and Shanghai Health and Medical Center.

Physicians in the intervention group will utilize the intelligent management system with AR glasses to aid in diagnosis and treatment, while patients will engage with the system's patient interface to access health education, follow-up reminders, and AI-powered home consultation features. In contrast, physicians in the control group will provide routine diagnoses and treatments, with their patients receiving standard health education and follow-up care. The trial was designed with the assistance of a digital twin-based clinical research system (termed X Town).

By comprehensively evaluating diagnostic quality, physicians' clinical abilities, patient-reported outcomes, and system appraisals, this study will assess the effectiveness of the clinical intelligent management system in enhancing the quality of primary care and patient management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Receiving care at a community health service center
  • Able to understand and comply with the study procedures
  • Agrees to participate in the study and signs the informed consent form

排除标准

  • Patients with severe mental illness
  • Patients unable to independently complete the questionnaire
  • Patients expected to be unable to complete follow-ups within three months

结局指标

主要结局

Comprehensive Assessment of clinical performance

时间窗: From enrollment to the end of treatment at 3 months of all recruited cases

Primary Care Quaility Assessment Scales (range: 0 to 100 for each case; the higher scores means the better performance)

次要结局

  • AI-System's appraisal(At the end of 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tien Yin Wong

Professor

Tsinghua University

研究点 (1)

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