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

NCT ID: NCT06980064

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Intervention group (AI smartwatch assisted diagnosis)

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. General pratitioners will then integrate these smartwatch-derived findings with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis.

Group Type: EXPERIMENTAL

Smartwatch + GP

Intervention Type: DIAGNOSTIC_TEST

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.

Control group (general pratitioner only)

Participants in the control group will not wear smart watches. General pratitioners will base their diagnoses solely on clinical interviews and the aforementioned baseline examinations.

Group Type: ACTIVE_COMPARATOR

GP only

Intervention Type: DIAGNOSTIC_TEST

GPs will make diagnosis with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

GP only

GPs will make diagnosis with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Aged more than equal to 40 years, less than 69 years.

2. Having at least one of the following conditions (with one risk factor for cardiovascular and cerebrovascular diseases):

① Male ≥ 55 years old, female ≥ 65 years old; ② Smokers or those who quit smoking within the past 3 months prior to the visit; ③ Diabetes (type 1 or 2); ④ Hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) or currently taking antihypertensive medication; ⑤ Dyslipidemia: total cholesterol ≥ 5.18mmol/L, triglycerides ≥ 1.70mmol/L, high-density lipoprotein<1.04mmol or low-density lipoprotein ≥ 3.37mmol/L; ⑥ hsCRP>3.0 mg/L; ⑦ 10-year ASCVD risk of 20% or more (calculated according to the formula designed in the PREVENT study)

3. Agree to receive coronary CTA if suspected to have coronary artery stenosis.

4. Voluntarily joined and signed the informed consent.

Exclusion Criteria

1. Previously diagnosed with CAD or considered moderate to severe coronary stenosis (CAD-RADS grade 3 or above: stenosis degree of 50% or above) through coronary CTA or coronary angiography examination.

2. Pregnant women or women planning to become pregnant within the next year.

3. During the onset of the disease and needs in-hospital treatment.

4. Tattoos or other substances that affect optical signals on the wrist.

5. Severe arrhythmia patients, including third degree atrioventricular block, ventricular escape rhythm, severe sinus bradycardia, sick sinus syndrome, supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular flutter.

6. Physical disability, blindness, and deafness.

7. Allergic history of contrast agent containing iodine.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geriatric Hospital of Nanjing Medical University

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Yangzhou University

UNKNOWN

Sponsor Role: collaborator

Shanghai Health and Medical Center

UNKNOWN

Sponsor Role: collaborator

Weifang Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

CR & WSICO general hospital

UNKNOWN

Sponsor Role: collaborator

Xunxian People's Hospital

UNKNOWN

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Cuntai

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cuntai Zhang, PhD

Role: STUDY_CHAIR

Wuhan TongJi Hospital

Central Contacts

Yucong Zhang, PhD

Role: CONTACT

u201110541@hust.edu.cn

86 13627115411

Other Identifiers

2024S212

Identifier Type: -

Identifier Source: org_study_id