Clinical Intelligent Management System Pragmatic RCT

Recruiting now · Not applicable

Conditions studied: Primary Care Diseases

In brief

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.

Key facts

Study ID

NCT06893068

Run by

Tsinghua University

People needed

204

Starts

2025-04-13

Expected to finish

2025-07-31

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Shanghai Health and Medical Center — Wuxi, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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