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

NCT06980064 — Not applicable, Not yet recruiting, 800 participants, Tongji Hospital

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

Registry	NCT06980064
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, screening
Enrollment	800 (Estimated)
Sponsor	Tongji Hospital (Other); collaborators: Geriatric Hospital of Nanjing Medical University, Yangzhou University, Shanghai Health and Medical Center, Weifang Hospital of Traditional Chinese Medicine, CR & WSICO general hospital, Xunxian People's Hospital
Conditions	Coronary Stenosis, Cerebral Arterial Diseases, Hypertension, Parkinson Disease, Heart Failure, Peripheral Arterial Occlusive Disease, Thyroid Dysfunction
Interventions	Smartwatch + GP, GP only (Diagnostic test)
Dates	start 2025-06-01 (estimated), primary completion 2025-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2025-05-20, last updated 2025-05-20

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention group (AI smartwatch assisted diagnosis)	Experimental	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. General pratitioners 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)	Active comparator	Diagnostic Test: GP 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.

Smartwatch + GP (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.
GP only (Diagnostic test): GPs will make diagnosis with clinical interviews and aforementioned baseline examination results to formulate a final diagnosis.

+Outcome measures

Primary outcomes

Coronary heart disease [From enrollment to the diagnosis, generally within 1 week]: According to the results of coronary computed tomography angiography , coronary heart disease is diagnosed if the stenosis of the coronary artery exceeds 50% (CAD-RADS grade 3 and above).

Secondary outcomes

Major adverse cardiovascular events [From enrollment to 1 year of follow-up]: Major adverse cardiovascular events, including myocardial infarction, stroke, aortic dissection, cardiac arrest and death from baseline to 1 year of follow-up

Other outcomes

Detection rate of other major chronic diseases [From enrollment to the diagnosis, generally within 1 week]: All relevant diseases will be diagnosed according to relevant guidelines, including cerebral vascular stenosis (cerebral artery computed tomography angiography), hypertension (blood pressure measurement), nocturnal hypertension (blood pressure measurement), heart failure (echocardiogram), cardiomyopathy (echocardiogram), peripheral arterial disease (vascular ultrasonography), thyroid dysfunction (thyroid function test), systemic lupus erythematosus (symptom and laboratory tests), Parkinson's disease (symptom) and sleep apnea syndrome (polysomnography).

+Eligibility

Sex: All, ages: 40 Years to 69 Years

The inclusion criteria are as follows:

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.

The 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.

+Investigators

Cuntai Zhang, PhD, Study chair, Wuhan TongJi Hospital