HypertensionAISPNCT06935513
Wearable Devices Empowering Active Health Initiatives for High-Risk Stroke Populations
A study testing Wearable Devices in people with Hypertension and Diabetes, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hypertension, Diabetes, Atrial Fibrillation
- What is being tested?
- Wearable Devices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2025to 20 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosed with malignancies;
- Diagnosed with psychiatric disorders;
- Diagnosed with cognitive impairment;
- Unable to operate smart wearable devices.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226000
Qiuhong Ji, MD, PhD, +8613962916293, jiqiuhong@ntu.edu.cn
Tian Xu, MD, PhD, +8618251313276, xutian84@163.com
About this study
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
Read the 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
- Being tested
- Wearable Devices
- Medical subject headings
- Hypertension, Diabetes Mellitus, Atrial Fibrillation, Dyslipidemias, Smoking, Sedentary Behavior, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable DevicesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Wearable Devices |
| Without Wearable Devices | No intervention | Participants do not utilize wearable devices (smart wristbands) . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start20 Apr 2025
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiuhong Ji, MD, PhD, Study chair, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935513
- Sponsor's protocol ID
- 2025005
- Acronym
- AISP
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No