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Clinical Intelligent Management System Pragmatic RCT

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06893068
Enrollment
204
Registered
2025-03-25
Start date
2025-04-13
Completion date
2025-07-31
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Care Diseases

Brief summary

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.

Interventions

DEVICEAI-based clinical intelligent management system

The clinical intelligent management system, integrated with AR glasses and powered by a multimodal foundational model, is designed to improve the quality of outpatient care at community health service centers.

Sponsors

Tsinghua University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Comprehensive Assessment of clinical performanceFrom enrollment to the end of treatment at 3 months of all recruited casesPrimary Care Quaility Assessment Scales (range: 0 to 100 for each case; the higher scores means the better performance)

Secondary

MeasureTime frameDescription
AI-System's appraisalAt the end of 3 monthsSystem usability was accessed by participating doctors of an AI-assisted group using the Health Information Technology Usability Evaluation Scale, rated on a five-point Likert scale from strongly disagree (1) to strongly agree (5). (A higher scale value indicates higher perceived usability of the technology.)

Countries

China

Contacts

Primary ContactJing Gu
g950324@163.com86+(510)82335104

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026