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

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

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.

Sponsors & Collaborators

• Geriatric Hospital of Nanjing Medical University

  collaborator OTHER

• The Affiliated Hospital of Yangzhou University

  collaborator UNKNOWN

• Shanghai Health and Medical Center

  collaborator UNKNOWN

• Weifang Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• CR & WSICO general hospital

  collaborator UNKNOWN

• Xunxian People's Hospital

  collaborator UNKNOWN

• Tongji Hospital

  lead OTHER

Principal Investigators

• Cuntai Zhang, PhD · Wuhan TongJi Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2025-12-31

Completion

2026-12-31