NCT06980064

Wearable Devices Assist in the Detection, Screening, and Management of Major Diseases in Middle-aged and Elderly Populations

Wearable Devices Assist in the Detection, Screening, and Management of Major Diseases in Middle-aged and Elderly Populations: a Multicenter Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled trial is to evaluate the effectiveness of wearable devices (Huawei smartwatches) in aiding the detection, and screening of major diseases (e.g., coronary artery disease, hypertension) in middle-aged and elderly populations aged 40-69 years with cardiovascular risk factors (e.g., smoking, diabetes, hypertension, dyslipidemia). The main questions it aims to answer are: Does AI-assisted diagnosis using wearable device data improve the detection rate of coronary artery stenosis (CAD-RADS ≥3) compared to standard physician assessment without AI assistance? Does the intervention reduce the incidence of coronary artery disease-related events (e.g., angina, myocardial infarction) within one year? Researchers will compare the intervention group (AI model-assisted diagnosis based on Huawei smartwatch data) with the control group (standard assessment) to determine if the AI-aided smartwatch approach enhances diagnostic accuracy and clinical outcomes. Participants will: （Intervention group）Wear a Huawei smartwatch for 24 hours to collect physiological data (e.g., PPG signals, heart rate, motion). Undergo baseline assessments, including medical history review, physical exams, and laboratory tests. Receive a preliminary diagnosis from a general practitioner. Complete a follow-up evaluation after one year to track cardiovascular events and other disease outcomes. Undergo coronary CTA if suspected of coronary stenosis.

Conditions

• Coronary Stenosis
• Cerebral Arterial Diseases
• Hypertension
• Parkinson Disease
• Heart Failure
• Peripheral Arterial Occlusive Disease
• Thyroid Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Smartwatch + GP	Participants in the intervention group will be required to wear a smartwatch continuously for 24 hours. After this period, the collected data will be processed using a pre-trained foundational model for disease diagnosis, generating preliminary diagnostic suggestions. GPs will then integrate these smartwatch-derived findings with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis.
DIAGNOSTIC_TEST	GP only	GPs will make diagnosis with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2025-05-20
• Last updated: 2025-05-20