HypertensionNCT07089810
Effect of Digital Intervention on Self-management of Hypertensive Patients at High Risk of Stroke
A study testing Digital intervention has a high blood pressure in the high-risk population of stroke Study on the effect of stress on self-management behavior of patients in people with Hypertension and Mhealth, run by Affiliated Hospital of Nantong University.
Trial summary
Stroke is the second leading cause of death in the world, and the number of stroke patients in China ranks the first in the world. Hypertension is the most important risk factor. Studies have shown that 80% of stroke can be prevented by controlling risk factors. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hypertension, Mhealth
- What is being tested?
- Digital intervention has a high blood pressure in the high-risk population of stroke Study on the effect of stress on self-management behavior of patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 10 Jan 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypertensive patients at high risk of stroke screened in the National Screening and Intervention Project for High-risk Population of Stroke (2) willing to participate Cooperate and sign the informed consent form
Who cannot join
- TIA and stroke patients (2) severe cognitive impairment (MMSE≤9) and (3) inability to use smartphones (4) Refusal to participate
About this study
Official title: Digital Intervention Based on BCW Theory Has a High Blood Pressure in High-risk Population of Stroke Study on the Effect of Stress on Self-management Behavior of Patients
Stroke is the second leading cause of death in the world, and the number of stroke patients in China ranks the first in the world. Hypertension is the most important risk factor. Studies have shown that 80% of stroke can be prevented by controlling risk factors. However, the management level of hypertension patients in China is still low, and their self-management ability is insufficient.
Digital health management, such as remote monitoring, AI and mobile health platforms, provides a new way for hypertension prevention and control. Foreign studies have shown that digital interventions can effectively improve patients' self-management behaviors, such as diet, exercise and blood pressure control. Interventions based on wechat, APP and other tools in China have also achieved positive results, but face challenges such as patient acceptance, system adaptation and data continuity.
Based on behavior change wheel (BCW) theory and digital platform, this study formulated personalized intervention programs for hypertension patients in high-risk groups of stroke, and promoted health behavior change from three aspects of ability, motivation and opportunity **. By improving disease cognition and strengthening self-management, the incidence of stroke can be ultimately reduced, and a new strategy for hypertension prevention and control in the community can be provided.
- Conditions
- Hypertension, Mhealth
- Being tested
- Digital intervention has a high blood pressure in the high-risk population of stroke Study on the effect of stress on self-management behavior of patients
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital intervention has a high blood pressure in the high-risk population of stroke Study on the effect of stress on self-management behavior of patientsDevice
Intervention group (n = 60) : Interventions were developed for five behavioral problems, as follows:
- Lack of knowledge about hypertension
- Measures: APP push knowledge (risk factors, medication, lifestyle, etc.), blood pressure monitoring teaching, monthly online lectures, regular feedback and encouragement of blood pressure data.
- Poor medication compliance
- Measures: Medication reminders were set by the APP, and repeated and recorded when no medication was taken.
- Obesity/overweight Targets: BMI 18.5-23.9, waist circumference <90cm in men and <85cm in women Interventions: promoting knowledge about the dangers of obesity, daily exercise reminders, setting weight loss goals and encouraging weight loss.
- A high-sodium diet Target: <6g salt per day
- Measures: Release of low-salt dietary guidelines (graphic and text) and distribution of salt-limiting spoons (1-2 grams).
- Drinking too much Target: ≤25g alcohol per day for men and ≤15g for women; Weekly male ≤140g, female ≤80
| Study group | Role | What they receive |
|---|---|---|
| Digital intervention has a high blood pressure in the high-risk population of stroke Study | Experimental | The chronic disease management App developed by the Affiliated Hospital of Nantong University was used to digitally manage hypertension patients, construct personalized intervention programs for such patients, and implement effective supervision and management on the platform. By strengthening the cognition of the population on the disease, it can increase their ability to self-management health, promote the change of health behavior, and ultimately reduce the incidence of stroke Receives: Device: Digital intervention has a high blood pressure in the high-risk population of stroke Study on the effect of stress on self-management behavior of patients |
| The control group was given health education according to the community management routine of the 20 | No intervention | Patients in the control group will receive routine hypertension management in the community according to the recommendations of the Chinese Guidelines for the Prevention and Treatment of Hypertension (2024), including health education, lifestyle intervention, blood pressure monitoring, and regular follow-up **, but without the use of digital chronic disease management App. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension Self-Management Behavior Rating Scale (HPSMBRS)
Measured: From the beginning of enrollment to the end 6 months later
Hypertension Knowledge Scale (HK-LS)
Measured: From the beginning of enrollment to the end 6 months later
Stroke premonitory symptom alertness assessment questionnaire
Measured: From the beginning of enrollment to the end 6 months later
Self-rating Depression Scale (PHQ-9)
Measured: From the beginning of enrollment to the end 6 months later
Generalized Anxiety Disorder-7 (GAD-7)
Measured: From the beginning of enrollment to the end 6 months later
Secondary outcomes (6)
Blood Pressure (mmHg)
Measured: From the beginning of enrollment to the end 6 months later
Blood lipid (mmol/L)
Measured: From the beginning of enrollment to the end 6 months later
Fasting blood glucose (mmol/L)
Measured: From the beginning of enrollment to the end 6 months later
Glycosylated hemoglobin (HbA1c)(%)
Measured: From the beginning of enrollment to the end 6 months later
Blood homocysteine (Hcy) (mmol/L)
Measured: From the beginning of enrollment to the end 6 months later
Is the risk of stroke reduced? : Risk prediction for atherosclerotic cardiovascular disease in China Prediction for ASCVD Risk in China, China-PAR
Measured: From the beginning of enrollment to the end 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion10 Jan 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.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089810
- Sponsor's protocol ID
- 2025-K116-01
- Status last verified
- Jun 2025
- First submitted
- 22 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Intervention Based on BCW Theory Has a High Blood Pressure in High-risk Population of Stroke Study on the Effect of Stress on Self-management Behavior of Patients
- ClinicalTrials.gov ID
- NCT07089810
- Acronym / sponsor ID
- 2025-K116-01
- Conditions
- Hypertension, Mhealth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 28 Jul 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.
Stroke is the second leading cause of death in the world, and the number of stroke patients in China ranks the first in the world. Hypertension is the most important risk factor. Studies have shown that 80% of stroke can be prevented by controlling risk factors. However, the management level of hypertension patients in China is still low, and their self-management ability is insufficient.
Digital health management, such as remote monitoring, AI and mobile health platforms, provides a new way for hypertension prevention and control. Foreign studies have shown that digital interventions can effectively improve patients' self-management behaviors, such as diet, exercise and blood pressure control. Interventions based on wechat, APP and other tools in China have also achieved positive results, but face challenges such as patient acceptance, system adaptation and data continuity.
Based on behavior change wheel (BCW) theory and digital platform, this study formulated personalized intervention programs for hypertension patients in high-risk groups of stroke, and promoted health behavior change from three aspects of ability, motivation and opportunity **. By improving disease cognition and strengthening self-management, the incidence of stroke can be ultimately reduced, and a new strategy for hypertension prevention and control in the community can be provided.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital intervention has a high blood pressure in the high-risk population of stroke Study | Experimental | Device: Digital intervention has a high blood pressure in the high-risk population of stroke Study on the effect of stress on self-management behavior of patientsThe chronic disease management App developed by the Affiliated Hospital of Nantong University was used to digitally manage hypertension patients, construct personalized intervention programs for such patients, and implement effective supervision and management on the platform. By strengthening the cognition of the population on the disease, it can increase their ability to self-management health, promote the change of health behavior, and ultimately reduce the incidence of stroke |
| The control group was given health education according to the community management routine of the 20 | No intervention | –Patients in the control group will receive routine hypertension management in the community according to the recommendations of the Chinese Guidelines for the Prevention and Treatment of Hypertension (2024), including health education, lifestyle intervention, blood pressure monitoring, and regular follow-up **, but without the use of digital chronic disease management App. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hypertensive patients at high risk of stroke screened in the National Screening and Intervention Project for High-risk Population of Stroke (2) willing to participate Cooperate and sign the informed consent form
Key exclusion criteria (1 listed)
- TIA and stroke patients (2) severe cognitive impairment (MMSE≤9) and (3) inability to use smartphones (4) Refusal to participate
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 |
|---|---|---|
| Digital intervention has a high blood pressure in the high-risk population of stroke Study on the effect of stress on self-management behavior of patientsIntervention group (n = 60) : Interventions were developed for five behavioral problems, as follows: 1. Lack of knowledge about hypertension - Measures: APP push knowledge (risk factors, medication, lifestyle, etc.), blood pressure monitoring teaching, monthly online lectures, regular feedback and encouragement of blood pressure data. 2. Poor medication compliance - Measures: Medication reminders were set by the APP, and repeated and recorded when no medication was taken. 3. Obesity/overweight Targets: BMI 18.5-23.9, waist circumference <90cm in men and <85cm in women Interventions: promoting knowledge about the dangers of obesity, daily exercise reminders, setting weight loss goals and encouraging weight loss. 4. A high-sodium diet Target: <6g salt per day - Measures: Release of low-salt dietary guidelines (graphic and text) and distribution of salt-limiting spoons (1-2 grams). 5. Drinking too much Target: ≤25g alcohol per day for men and ≤15g for women; Weekly male ≤140g, female ≤80 | Device | Digital intervention has a high blood pressure in the high-risk population of stroke Study |
Primary outcome
Hypertension Self-Management Behavior Rating Scale (HPSMBRS)
Time frame: From the beginning of enrollment to the end 6 months later
Hypertension Knowledge Scale (HK-LS)
Time frame: From the beginning of enrollment to the end 6 months later
Stroke premonitory symptom alertness assessment questionnaire
Time frame: From the beginning of enrollment to the end 6 months later
Self-rating Depression Scale (PHQ-9)
Time frame: From the beginning of enrollment to the end 6 months later
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: From the beginning of enrollment to the end 6 months later
6 secondary outcomes
Blood Pressure (mmHg)
Time frame: From the beginning of enrollment to the end 6 months later
Blood lipid (mmol/L)
Time frame: From the beginning of enrollment to the end 6 months later
Fasting blood glucose (mmol/L)
Time frame: From the beginning of enrollment to the end 6 months later
Glycosylated hemoglobin (HbA1c)(%)
Time frame: From the beginning of enrollment to the end 6 months later
Blood homocysteine (Hcy) (mmol/L)
Time frame: From the beginning of enrollment to the end 6 months later
Is the risk of stroke reduced? : Risk prediction for atherosclerotic cardiovascular disease in China Prediction for ASCVD Risk in China, China-PAR
Time frame: From the beginning of enrollment to the end 6 months later
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 28 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Digital intervention has a high blood pressure in the high-risk population of stroke Study on the effect of stress on self-management behavior of patients in people with Hypertension and Mhealth, run by Affiliated Hospital of Nantong University.
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 1 inclusion and 1 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 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension Self-Management Behavior Rating Scale (HPSMBRS) (time frame: From the beginning of enrollment to the end 6 months later). The study lists 5 primary outcomes in all. 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 28 Jul 2025.