Wearable Devices Empowering Active Health Initiatives for High-Risk Stroke Populations

NCT06935513 | Recruiting

• 1 other identifier: 2025005
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the control effect of smart wearable devices on key risk factors in the high-risk populations for stroke

Conditions

Hypertension; Diabetes; Atrial Fibrillation; Dyslipidemia; Smoking; Physical Inactivity; Obesity and Overweight

Outcome Measures

Primary Outcomes (1)

• medication adherence and risk factor control rates

  1.The medication rates and control rates for hypertension; 2.The medication rates and control rates for hyperglycemia; 3. The medication rates and control rates for hyperlipidemia; 4.The medication rates and control rates for obesity.

  6 months

Secondary Outcomes (1)

• incident vascular events, including stroke, coronary heart disease (CHD), peripheral vascular disease (PVD), and other related cardiovascular events

  6 months

Study Arms (2)

With Wearable Devices

EXPERIMENTAL

Participants utilize wearable devices (smart wristbands) 24 hours a day for 6 months and receive medication reminders for each use and heart rate monitoring.

Behavioral: Wearable Devices

Without Wearable Devices

NO INTERVENTION

Participants do not utilize wearable devices (smart wristbands) .

Interventions

Wearable Devices BEHAVIORAL

Participants utilize wearable devices (smart wristbands) 24 hours a day for 6 months. Wearable devices can provide medication reminders for each use and heart rate monitoring.

With Wearable Devices

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with hypertension;
• Diagnosed with diabetes;
• Diagnosed with atrial fibrillation;
• Smoking subjects;
• Physical inactive subjects；
• Obesity and overweight subjects;
• Must be able to use smart wearable devices.

You may not qualify if:

• Diagnosed with malignancies;
• Diagnosed with psychiatric disorders;
• Diagnosed with cognitive impairment;
• Unable to operate smart wearable devices.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

RECRUITING

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Atrial Fibrillation; Dyslipidemias; Smoking; Sedentary Behavior; Obesity; Overweight

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Behavior; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Qiuhong Ji, MD, PhD

  Affiliated Hospital of Nantong University

  STUDY CHAIR

Central Study Contacts

Qiuhong Ji, MD, PhD

CONTACT

+8613962916293; jiqiuhong@ntu.edu.cn

Pengyu Gong, MD

CONTACT

+8615720800870; gongpengyu@ntu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 20, 2025
• Study Start: April 20, 2025
• Primary Completion: October 20, 2025
• Study Completion: April 20, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)