HypertensionNCT06949306
Intervention Study on Digital Health Management
A study testing Bracelet, assistant, APP: the "golden triangle" of smart life in people with Hypertension and Hyperlipidemia, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The aim of this study is to construct a digital precision intervention system for cardiometabolism disorders based on the characteristics of the Chinese population, focusing on the core components of metabolic syndrome such as hypertension, hyperglycemia, and obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Hyperlipidemia
- What is being tested?
- Bracelet, assistant, APP: the "golden triangle" of smart life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2030
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Complicated with chronic liver and kidney disease, coronary heart disease, heart failure and severe valvular disease
- Previous cardiovascular and cerebrovascular events
- Diastolic blood pressure ≥99mmHg
- Glycated hemoglobin ≥6.5
- Other life expectancy such as cancer is less than 5 years
- Participate in other clinical trials
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
Department of Cardiology,Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
About this study
Official title: Intervention of a Digital Health Management Program in Patients With Cardiometabolic Disorders: a Real-world Study
The aim of this study is to construct a digital precision intervention system for cardiometabolism disorders based on the characteristics of the Chinese population, focusing on the core components of metabolic syndrome such as hypertension, hyperglycemia, and obesity. Through dynamic monitoring of wearable devices, the individualized risk factors (including genetic predisposition, lifestyle, and psychological factors) of metabolic disorders were systematically analyzed, and dynamic intervention strategies were formulated accordingly. The closed-loop management of "monitor-feedback-optimization" based on the digital platform will provide patients with one-stop metabolic risk assessment and panoramic health management plan, realizing a paradigm shift from "generalized intervention" to "precise regulation". By reducing the abnormal fluctuations of key metabolic indicators such as blood pressure, blood glucose, and blood lipids, the risk of cardiovascular events will eventually be reduced, the long-term quality of life of patients will be improved, and a practical path of "digital therapy" can be promoted for the prevention and control of chronic diseases in China
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- Bracelet, assistant, APP: the "golden triangle" of smart life
- Keywords
- Cardiometabolic abnormalities, Digital Interventions
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bracelet, assistant, APP: the "golden triangle" of smart lifeOther
The lifestyle intervention was carried out through the bracelet, Little Assistant and Keyhealth APP for 24 weeks, and the daily data synchronization of the APP and weekly AI feedback were performed. After 24 weeks, blood glucose, blood lipid, blood pressure, CAI and other indicators were monitored.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular digital management group | Experimental | Participants used a bracelet and an APP assistant for lifestyle interventions Receives: Other: Bracelet, assistant, APP: the "golden triangle" of smart life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in diastolic blood pressure after 24 weeks
Measured: 24 weeks following intervention
Secondary outcomes (1)
Values for changes in Hba1c or BMI or CAI after 24 weeks
Measured: 24 weeks following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949306
- Sponsor's protocol ID
- NSS_3.0
- Status last verified
- Mar 2025
- First submitted
- 13 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention of a Digital Health Management Program in Patients With Cardiometabolic Disorders: a Real-world Study
- ClinicalTrials.gov ID
- NCT06949306
- Acronym / sponsor ID
- NSS_3.0
- Conditions
- Hypertension, Hyperlipidemia
- Keywords
- Cardiometabolic abnormalities, Digital Interventions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 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 aim of this study is to construct a digital precision intervention system for cardiometabolism disorders based on the characteristics of the Chinese population, focusing on the core components of metabolic syndrome such as hypertension, hyperglycemia, and obesity. Through dynamic monitoring of wearable devices, the individualized risk factors (including genetic predisposition, lifestyle, and psychological factors) of metabolic disorders were systematically analyzed, and dynamic intervention strategies were formulated accordingly. The closed-loop management of "monitor-feedback-optimization" based on the digital platform will provide patients with one-stop metabolic risk assessment and panoramic health management plan, realizing a paradigm shift from "generalized intervention" to "precise regulation". By reducing the abnormal fluctuations of key metabolic indicators such as blood pressure, blood glucose, and blood lipids, the risk of cardiovascular events will eventually be reduced, the long-term quality of life of patients will be improved, and a practical path of "digital therapy" can be promoted for the prevention and control of chronic diseases in China
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular digital management group | Experimental | Other: Bracelet, assistant, APP: the "golden triangle" of smart lifeParticipants used a bracelet and an APP assistant for lifestyle interventions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Complicated with chronic liver and kidney disease, coronary heart disease, heart failure and severe valvular disease
- Previous cardiovascular and cerebrovascular events
- Diastolic blood pressure ≥99mmHg
- Glycated hemoglobin ≥6.5
- Other life expectancy such as cancer is less than 5 years
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 |
|---|---|---|
| Bracelet, assistant, APP: the "golden triangle" of smart lifeThe lifestyle intervention was carried out through the bracelet, Little Assistant and Keyhealth APP for 24 weeks, and the daily data synchronization of the APP and weekly AI feedback were performed. After 24 weeks, blood glucose, blood lipid, blood pressure, CAI and other indicators were monitored. | Other | Cardiovascular digital management group |
Primary outcome
Changes in diastolic blood pressure after 24 weeks
Time frame: 24 weeks following intervention
1 secondary outcome
Values for changes in Hba1c or BMI or CAI after 24 weeks
Time frame: 24 weeks following intervention
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 29 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bracelet, assistant, APP: the "golden triangle" of smart life in people with Hypertension and Hyperlipidemia, run by Shanghai 10th People's Hospital 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 0 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 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 Yi Zhang (18917686332, yizshcn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in diastolic blood pressure after 24 weeks (time frame: 24 weeks following intervention). 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 29 Apr 2025.