Resistant HypertensionNCT06819241
Self-Management of Blood Pressure in Resistant Hypertension
A study testing AI chatbot support and telemonitoring and case management in people with Resistant Hypertension, run by Taichung Veterans General Hospital at 5 sites in Taiwan.
Trial summary
The trial is a 12-month randomized, parallel-group study comparing three arms: (1) HBP self-management with AI chatbot support, (2) HBP self-management without AI chatbot support, and (3) usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- AI chatbot support and telemonitoring and case management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesTaiwan
- Study dates
- 16 Feb 2025to 31 Oct 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- receiving ≥3 antihypertensive medications of different classes, including a diuretic, and baseline BP >130/80 mmHg; or receiving ≥ 4 medications regardless of BP
Who cannot join
- unable to conduct self-monitor BP because of cognitive dysfunction
- poor adherence to medication
- poor digital capabilities
- pregnant
- terminal disease
- an acute cardiovascular event in the previous 3 months
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hao-Min Cheng, M.D., Ph.D contact
5 sites in 1 country
Taiwan5 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Tsung-Hsien Lin, M.D., Ph.D., 886-7-3121101, Lth@kmu.edu.tw
Kaohsiung Veterans General Hospital
Kaohsiung City, 813414
Wen-Hwa Wang, M.D., Ph.D., 886-7-3422121, passtheboard1@gmail.com
Taichung Veterans General Hospital
Taichung, 407
Wei-Wen Lin, M.D., Ph.D., 886-4-23592525, weinlinecho@gmail.com
National Taiwan University Hospital
Taipei, 100
Yen-Hung Lin, M.D., 886-2-23123456, austinr34@gmail.com
Taipei Veterans General Hospital
Taipei, 112
Hao-Min Cheng, M.D., Ph.D., 886-2-28757302, hmcheng@vghtpe.gov.tw
About this study
Official title: Effectiveness of Self-Management of Blood Pressure on the Management of Resistant Hypertension
The trial is a 12-month randomized, parallel-group study comparing three arms: (1) HBP self-management with AI chatbot support, (2) HBP self-management without AI chatbot support, and (3) usual care. The primary objective is to evaluate differences in blood pressure changes and medication compliance between groups at 6 and 12 months.
Read the detailed description
Hypertension management Hypertension, characterized by persistently elevated BP, stands as a predominant risk factor for cardiovascular disease (CVD) and all-cause mortality worldwide. Its importance lies in its pervasive prevalence and significant contribution to the global burden of disease. Hypertension not only increases the risk of adverse cardiovascular events such as heart attack, stroke, and heart failure but also predisposes individuals to a spectrum of other health complications including chronic kidney disease, peripheral artery disease, and cognitive impairment. Furthermore, hypertension often coexists with various metabolic disorders such as diabetes mellitus and dyslipidemia, amplifying the overall cardiovascular risk. Addressing hypertension is thus imperative for public health initiatives aimed at reducing the burden of CVD and improving population health outcomes.
Hypertension represents a modifiable risk element. Effective management strategies for hypertension encompass lifestyle modifications, pharmacological interventions, and regular monitoring to achieve and maintain optimal BP levels. By recognizing the importance of hypertension and implementing comprehensive approaches to its prevention, diagnosis, and treatment, healthcare systems can mitigate its adverse effects and promote better cardiovascular health on a global scale.
Resistant hypertension Resistant hypertension represents a critical subset of hypertension that presents challenges in achieving adequate BP control despite treatment with multiple antihypertensive medications. Its importance lies in its association with heightened cardiovascular risk, including an increased likelihood of adverse events such as stroke, heart attack, and kidney disease. Effective management of resistant hypertension requires comprehensive evaluation, tailored treatment regimens, and close monitoring to mitigate these risks. Addressing resistant hypertension is crucial for optimizing patient outcomes and reducing the burden of cardiovascular morbidity and mortality.
Self-monitoring of BP Self-monitoring of BP holds paramount significance in the management of hypertension and related cardiovascular complications. This practice entails patients regularly measuring their BP outside of clinical settings, often using HBP monitoring devices. The importance of self-monitoring BP lies in its ability to provide healthcare professionals with a more comprehensive understanding of patients' BP patterns, facilitating personalized treatment plans tailored to individual needs. Additionally, self-monitoring empowers patients to actively engage in their healthcare by promoting awareness of their BP levels and fostering adherence to prescribed treatment regimens. Research indicates that incorporating self-monitoring into hypertension management strategies leads to more accurate diagnosis, optimized treatment adjustments, and improved BP control. Furthermore, self-monitoring enables early detection of fluctuations in BP, aiding in the prevention of hypertensive crises and associated complications such as stroke, heart attack, and kidney disease. Moreover, self-monitoring offers a cost-effective approach to hypertension management by reducing the need for frequent clinic visits and hospitalizations while enhancing patient satisfaction and autonomy. Overall, the integration of self-monitoring of BP into clinical practice represents a pivotal component of holistic hypertension care, offering numerous benefits in terms of patient outcomes, healthcare resource utilization, and long-term cardiovascular risk reduction. Therefore, the Taiwan Society of Cardiology and Taiwan Hypertension Society have embraced the 722 protocol as a standardized approach for HBP monitoring. The 722 protocol refers to duplicate BP readings taken per occasion ("2"), twice daily ("2"), over seven consecutive days ("7"). This protocol serves to validate hypertension diagnoses and to tailor antihypertensive medication adjustments accordingly.
Telemonitoring Telemonitoring plays a pivotal role in hypertension care by facilitating remote monitoring of patients' BP levels and treatment adherence. This approach enables healthcare providers to obtain real-time data on patients' BP readings, allowing for timely interventions and adjustments to treatment regimens as needed. By empowering patients to actively engage in self-management and promoting regular monitoring outside of clinical settings, telemonitoring helps to improve BP control and reduce the risk of cardiovascular complications associated with uncontrolled hypertension. Furthermore, telemonitoring enhances patient-provider communication and enables more personalized and proactive healthcare delivery, ultimately contributing to better patient outcomes in hypertension management.
Artificial intelligence chatbot The application of artificial intelligence (AI) chatbots in clinical settings represents a burgeoning area of research and implementation. These AI-driven conversational agents offer promising avenues for enhancing patient care through various functionalities, including symptom assessment, medication adherence support, and patient education. By leveraging natural language processing and machine learning algorithms, AI chatbots can interact with patients in real-time, providing personalized responses and recommendations. Moreover, AI chatbots have the potential to streamline administrative tasks, such as appointment scheduling and medical record retrieval, thereby improving workflow efficiency in healthcare settings. As the technology continues to evolve, the integration of AI chatbots holds immense potential for augmenting clinical decision-making processes and optimizing patient outcomes.
Investigational product(s)
- HBP self-management with AI chatbot support: Integrating the practice of self-monitoring of HBP with the use of AI chatbot responses.
- HBP self-management without AI chatbot support: Combining self-monitoring of HBP with telemonitoring and case management.
Both arms mentioned above include reminders for patients to monitor their BP and take antihypertensive medications. They also involve tracking BP readings over time and offering feedback. Moreover, these arms offer physician-endorsed guidance on modifying the dosage of antihypertensive medication and implementing lifestyle adjustments. They offer education on hypertension and the potential side effects of medication, as well as assistance with medication refills and scheduling appointments.
Risks
- Technological barriers: Certain individuals, specifically elderly patients or those with limited proficiency in technology, may encounter difficulties when attempting to utilize the AI chatbot proficiently.
- Privacy and data security: AI chatbots are utilized to gather and analyze sensitive health information. It is crucial to implement strong measures to guarantee the security and privacy of data.
- Bias and inaccuracy: AI chatbots depend on algorithms that are trained using pre-existing data, which can potentially introduce bias or inaccuracies in the recommendations they offer. Regular surveillance and revisions of the chatbot's algorithms are imperative.
Benefits
- Personalized support: Patients can be support from an AI chatbot or case manager by receiving personalized recommendations and reminders, potentially enhancing compliance to medication regimens and lifestyle changes.
- Improved BP control: HBP self-management with and without AI chatbot support may lead to better BP control compared to usual care. This can reduce the risk of cardiovascular events such as heart attacks and strokes.
- Reduced healthcare costs: Improved BP control and reduced healthcare utilization due to better self-management HBP may lead to cost savings for both patients and healthcare systems.
- Conditions
- Resistant Hypertension
- Being tested
- AI chatbot support, telemonitoring and case management
- Keywords
- resistant hypertension, self-management of blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI chatbot supportBehavioural
Integrating the practice of self-monitoring of HBP with the use of AI chatbot responses. This arm includes reminders for patients to monitor their BP and take antihypertensive medications, and involves tracking BP readings over time and offering feedback. Moreover, this arm offers physician-endorsed guidance on modifying the dosage of antihypertensive medication and implementing lifestyle adjustments. It offers education on hypertension and the potential side effects of medication, as well as assistance with medication refills and scheduling appointments.
telemonitoring and case managementBehavioural
Combining self-monitoring of HBP with telemonitoring and case management. This arm includes reminders for patients to monitor their BP and take antihypertensive medications, and involves tracking BP readings over time and offering feedback. Moreover, this arm offers physician-endorsed guidance on modifying the dosage of antihypertensive medication and implementing lifestyle adjustments. It offers education on hypertension and the potential side effects of medication, as well as assistance with medication refills and scheduling appointments.
| Study group | Role | What they receive |
|---|---|---|
| HBP self-management with AI chatbot support | Experimental | Self-monitoring of HBP combined with AI chatbot responses Receives: Behavioral: AI chatbot support |
| HBP self-management without AI chatbot support | Experimental | Self-monitoring HBP combined with telemonitoring and case management Receives: Behavioral: telemonitoring and case management |
| HBP-guided usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HBP (systolic BP and diastolic BP) between baseline and each follow-up visit.
Primary endpoint
Measured: 6 and 12 months
Secondary outcomes (2)
Office blood pressure endpoint
Difference between intervention and control groups in change in office blood pressure (OBP; systolic BP and diastolic BP) between baseline and each follow-up visit.
Measured: 6 and 12 months
Antihypertensive drug compliance endpoint
Difference between intervention and control groups in compliance to antihypertensive drugs during follow-up period, measured by pill count method.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start16 Feb 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819241
- Sponsor's protocol ID
- CF24368A
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Self-Management of Blood Pressure on the Management of Resistant Hypertension
- ClinicalTrials.gov ID
- NCT06819241
- Acronym / sponsor ID
- CF24368A
- Conditions
- Resistant Hypertension
- Keywords
- resistant hypertension, self-management of blood pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 16 Feb 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 11 Feb 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 trial is a 12-month randomized, parallel-group study comparing three arms: (1) HBP self-management with AI chatbot support, (2) HBP self-management without AI chatbot support, and (3) usual care. The primary objective is to evaluate differences in blood pressure changes and medication compliance between groups at 6 and 12 months.
Detailed description
Hypertension management Hypertension, characterized by persistently elevated BP, stands as a predominant risk factor for cardiovascular disease (CVD) and all-cause mortality worldwide. Its importance lies in its pervasive prevalence and significant contribution to the global burden of disease. Hypertension not only increases the risk of adverse cardiovascular events such as heart attack, stroke, and heart failure but also predisposes individuals to a spectrum of other health complications including chronic kidney disease, peripheral artery disease, and cognitive impairment. Furthermore, hypertension often coexists with various metabolic disorders such as diabetes mellitus and dyslipidemia, amplifying the overall cardiovascular risk. Addressing hypertension is thus imperative for public health initiatives aimed at reducing the burden of CVD and improving population health outcomes.
Hypertension represents a modifiable risk element. Effective management strategies for hypertension encompass lifestyle modifications, pharmacological interventions, and regular monitoring to achieve and maintain optimal BP levels. By recognizing the importance of hypertension and implementing comprehensive approaches to its prevention, diagnosis, and treatment, healthcare systems can mitigate its adverse effects and promote better cardiovascular health on a global scale.
Resistant hypertension Resistant hypertension represents a critical subset of hypertension that presents challenges in achieving adequate BP control despite treatment with multiple antihypertensive medications. Its importance lies in its association with heightened cardiovascular risk, including an increased likelihood of adverse events such as stroke, heart attack, and kidney disease. Effective management of resistant hypertension requires comprehensive evaluation, tailored treatment regimens, and close monitoring to mitigate these risks. Addressing resistant hypertension is crucial for optimizing patient outcomes and reducing the burden of cardiovascular morbidity and mortality.
Self-monitoring of BP Self-monitoring of BP holds paramount significance in the management of hypertension and related cardiovascular complications. This practice entails patients regularly measuring their BP outside of clinical settings, often using HBP monitoring devices. The importance of self-monitoring BP lies in its ability to provide healthcare professionals with a more comprehensive understanding of patients' BP patterns, facilitating personalized treatment plans tailored to individual needs. Additionally, self-monitoring empowers patients to actively engage in their healthcare by promoting awareness of their BP levels and fostering adherence to prescribed treatment regimens. Research indicates that incorporating self-monitoring into hypertension management strategies leads to more accurate diagnosis, optimized treatment adjustments, and improved BP control. Furthermore, self-monitoring enables early detection of fluctuations in BP, aiding in the prevention of hypertensive crises and associated complications such as stroke, heart attack, and kidney disease. Moreover, self-monitoring offers a cost-effective approach to hypertension management by reducing the need for frequent clinic visits and hospitalizations while enhancing patient satisfaction and autonomy. Overall, the integration of self-monitoring of BP into clinical practice represents a pivotal component of holistic hypertension care, offering numerous benefits in terms of patient outcomes, healthcare resource utilization, and long-term cardiovascular risk reduction. Therefore, the Taiwan Society of Cardiology and Taiwan Hypertension Society have embraced the 722 protocol as a standardized approach for HBP monitoring. The 722 protocol refers to duplicate BP readings taken per occasion ("2"), twice daily ("2"), over seven consecutive days ("7"). This protocol serves to validate hypertension diagnoses and to tailor antihypertensive medication adjustments accordingly.
Telemonitoring Telemonitoring plays a pivotal role in hypertension care by facilitating remote monitoring of patients' BP levels and treatment adherence. This approach enables healthcare providers to obtain real-time data on patients' BP readings, allowing for timely interventions and adjustments to treatment regimens as needed. By empowering patients to actively engage in self-management and promoting regular monitoring outside of clinical settings, telemonitoring helps to improve BP control and reduce the risk of cardiovascular complications associated with uncontrolled hypertension. Furthermore, telemonitoring enhances patient-provider communication and enables more personalized and proactive healthcare delivery, ultimately contributing to better patient outcomes in hypertension management.
Artificial intelligence chatbot The application of artificial intelligence (AI) chatbots in clinical settings represents a burgeoning area of research and implementation. These AI-driven conversational agents offer promising avenues for enhancing patient care through various functionalities, including symptom assessment, medication adherence support, and patient education. By leveraging natural language processing and machine learning algorithms, AI chatbots can interact with patients in real-time, providing personalized responses and recommendations. Moreover, AI chatbots have the potential to streamline administrative tasks, such as appointment scheduling and medical record retrieval, thereby improving workflow efficiency in healthcare settings. As the technology continues to evolve, the integration of AI chatbots holds immense potential for augmenting clinical decision-making processes and optimizing patient outcomes.
Investigational product(s)
- HBP self-management with AI chatbot support: Integrating the practice of self-monitoring of HBP with the use of AI chatbot responses.
- HBP self-management without AI chatbot support: Combining self-monitoring of HBP with telemonitoring and case management.
Both arms mentioned above include reminders for patients to monitor their BP and take antihypertensive medications. They also involve tracking BP readings over time and offering feedback. Moreover, these arms offer physician-endorsed guidance on modifying the dosage of antihypertensive medication and implementing lifestyle adjustments. They offer education on hypertension and the potential side effects of medication, as well as assistance with medication refills and scheduling appointments.
Risks
- Technological barriers: Certain individuals, specifically elderly patients or those with limited proficiency in technology, may encounter difficulties when attempting to utilize the AI chatbot proficiently.
- Privacy and data security: AI chatbots are utilized to gather and analyze sensitive health information. It is crucial to implement strong measures to guarantee the security and privacy of data.
- Bias and inaccuracy: AI chatbots depend on algorithms that are trained using pre-existing data, which can potentially introduce bias or inaccuracies in the recommendations they offer. Regular surveillance and revisions of the chatbot's algorithms are imperative.
Benefits
- Personalized support: Patients can be support from an AI chatbot or case manager by receiving personalized recommendations and reminders, potentially enhancing compliance to medication regimens and lifestyle changes.
- Improved BP control: HBP self-management with and without AI chatbot support may lead to better BP control compared to usual care. This can reduce the risk of cardiovascular events such as heart attacks and strokes.
- Reduced healthcare costs: Improved BP control and reduced healthcare utilization due to better self-management HBP may lead to cost savings for both patients and healthcare systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HBP self-management with AI chatbot support | Experimental | Behavioral: AI chatbot supportSelf-monitoring of HBP combined with AI chatbot responses |
| HBP self-management without AI chatbot support | Experimental | Behavioral: telemonitoring and case managementSelf-monitoring HBP combined with telemonitoring and case management |
| HBP-guided usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years of age
- receiving ≥3 antihypertensive medications of different classes, including a diuretic, and baseline BP >130/80 mmHg; or receiving ≥ 4 medications regardless of BP
Key exclusion criteria (6 listed)
- unable to conduct self-monitor BP because of cognitive dysfunction
- poor adherence to medication
- poor digital capabilities
- pregnant
- terminal disease
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 |
|---|---|---|
| AI chatbot supportIntegrating the practice of self-monitoring of HBP with the use of AI chatbot responses. This arm includes reminders for patients to monitor their BP and take antihypertensive medications, and involves tracking BP readings over time and offering feedback. Moreover, this arm offers physician-endorsed guidance on modifying the dosage of antihypertensive medication and implementing lifestyle adjustments. It offers education on hypertension and the potential side effects of medication, as well as assistance with medication refills and scheduling appointments. | Behavioural | HBP self-management with AI chatbot support |
| telemonitoring and case managementCombining self-monitoring of HBP with telemonitoring and case management. This arm includes reminders for patients to monitor their BP and take antihypertensive medications, and involves tracking BP readings over time and offering feedback. Moreover, this arm offers physician-endorsed guidance on modifying the dosage of antihypertensive medication and implementing lifestyle adjustments. It offers education on hypertension and the potential side effects of medication, as well as assistance with medication refills and scheduling appointments. | Behavioural | HBP self-management without AI chatbot support |
Primary outcome
Change in HBP (systolic BP and diastolic BP) between baseline and each follow-up visit.
Time frame: 6 and 12 months
Primary endpoint
2 secondary outcomes
Office blood pressure endpoint
Time frame: 6 and 12 months
Antihypertensive drug compliance endpoint
Time frame: 6 and 12 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 11 Feb 2025.
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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.
Hao-Min Cheng, M.D., Ph.D contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI chatbot support and telemonitoring and case management in people with Resistant Hypertension, run by Taichung Veterans General Hospital at 5 sites in Taiwan.
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 2 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. 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 Wei-Wen Lin, M.D., Ph.D (886-4-23592525, weinlinecho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HBP (systolic BP and diastolic BP) between baseline and each follow-up visit. (time frame: 6 and 12 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 11 Feb 2025.