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

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

Study Overview

• Status: Recruiting
• Conditions: Smoking; Hypertension; Diabetes; Atrial Fibrillation; Dyslipidemia; Physical Inactivity; Obesity and Overweight
• Intervention / Treatment: Behavioral: Wearable Devices

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiuhong Ji, MD, PhD; Phone Number: +8613962916293; Email: jiqiuhong@ntu.edu.cn
• Study Contact Backup: Name: Pengyu Gong, MD; Phone Number: +8615720800870; Email: gongpengyu@ntu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226000
      • Recruiting
      • Affiliated Hospital of Nantong University
      • Contact: Qiuhong Ji, MD, PhD; Phone Number: +8613962916293; Email: jiqiuhong@ntu.edu.cn
      • Contact: Tian Xu, MD, PhD; Phone Number: +8618251313276; Email: xutian84@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Without Wearable Devices; Participants do not utilize wearable devices (smart wristbands) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
incident vascular events, including stroke, coronary heart disease (CHD), peripheral vascular disease (PVD), and other related cardiovascular events	Stroke is a sudden interruption of blood flow to the brain, caused by either a blockage (ischemic stroke) or rupture of a blood vessel (hemorrhagic stroke). Coronary heart disease is a cardiovascular condition characterized by the narrowing or blockage of the coronary arteries, the blood vessels that supply oxygen-rich blood to the heart muscle. Peripheral vascular diseases are circulatory disorders characterized by narrowing, blockage, or spasms in blood vessels outside the heart and brain, most commonly affecting arteries supplying the legs, arms, kidneys, or stomach.	6 months

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Study Chair: Qiuhong Ji, MD, PhD, Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2025
• Primary Completion (Estimated): October 20, 2025
• Study Completion (Estimated): April 20, 2026

Study Registration Dates

• First Submitted: March 30, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Nutrition Disorders; Heart Diseases; Metabolic Diseases; Overnutrition; Body Weight; Arrhythmias, Cardiac; Lipid Metabolism Disorders; Overweight; Atrial Fibrillation; Dyslipidemias
• Other Study ID Numbers: 2025005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No