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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Devices Empowering Active Health Initiatives for High-Risk Stroke Populations
- ClinicalTrials.gov ID
- NCT06935513
- Acronym / sponsor ID
- AISP / 2025005
- Conditions
- Hypertension, Diabetes, Atrial Fibrillation, Dyslipidemia, Smoking, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Wearable Devices | Experimental | Behavioral: Wearable DevicesParticipants utilize wearable devices (smart wristbands) 24 hours a day for 6 months and receive medication reminders for each use and heart rate monitoring. |
| Without Wearable Devices | No intervention | –Participants do not utilize wearable devices (smart wristbands) . |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with hypertension;
- Diagnosed with diabetes;
- Diagnosed with atrial fibrillation;
- Smoking subjects;
- Physical inactive subjects；
Key exclusion criteria (4 listed)
- Diagnosed with malignancies;
- Diagnosed with psychiatric disorders;
- Diagnosed with cognitive impairment;
- Unable to operate smart wearable devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable DevicesParticipants 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. | Behavioural | With Wearable Devices |
Primary outcome
medication adherence and risk factor control rates
Time frame: 6 months
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.
1 secondary outcome
incident vascular events, including stroke, coronary heart disease (CHD), peripheral vascular disease (PVD), and other related cardiovascular events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiuhong Ji, MD, PhD study chair
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Devices in people with Hypertension and Diabetes, run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiuhong Ji, MD, PhD (+8613962916293, jiqiuhong@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medication adherence and risk factor control rates (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.