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

NCT ID: NCT06935513

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-20
• Study Completion Date: 2026-04-20

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

Detailed Description

A randomized controlled study was conducted on the application of smart wearable devices in the intervention of high-risk populations for stroke, with a focus on whether the functions of smart wearable devices such as medication reminders, heart rate monitoring, and exercise reminders can effectively benefit the improvement of key risk factors for stroke, especially blood pressure, blood glucose, and blood lipids.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

With Wearable Devices

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

Group Type: EXPERIMENTAL

Wearable Devices

Intervention Type: 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.

Without Wearable Devices

Participants do not utilize wearable devices (smart wristbands) .

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wearable Devices

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with hypertension;

2. Diagnosed with diabetes;

3. Diagnosed with atrial fibrillation;

4. Smoking subjects;

5. Physical inactive subjects；

6. Obesity and overweight subjects;

7. Must be able to use smart wearable devices.

Exclusion Criteria

1. Diagnosed with malignancies;

2. Diagnosed with psychiatric disorders;

3. Diagnosed with cognitive impairment;

4. Unable to operate smart wearable devices.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiuhong Ji, MD, PhD

Role: STUDY_CHAIR

Affiliated Hospital of Nantong University

Locations

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiuhong Ji, MD, PhD

Role: CONTACT

jiqiuhong@ntu.edu.cn

+8613962916293

Pengyu Gong, MD

Role: CONTACT

gongpengyu@ntu.edu.cn

+8615720800870

Facility Contacts

Qiuhong Ji, MD, PhD

Role: primary

jiqiuhong@ntu.edu.cn

+8613962916293

Tian Xu, MD, PhD

Role: backup

xutian84@163.com

+8618251313276

Other Identifiers

2025005

Identifier Type: -

Identifier Source: org_study_id