Remote Monitoring Strategies for High Blood Pressure

(CHARMED Trial)

Overseen By Faviola Garcia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Pregnancy, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the most effective remote strategies for managing high blood pressure. It tests various methods, such as personalized feedback and automatic reminders, combined with clinic training. The focus is on assisting English- and Spanish-speaking individuals in maintaining healthy blood pressure levels. Those who have recorded high blood pressure readings (140/90 mmHg or higher) at least twice in the last 18 months and can read and write in English or Spanish may qualify. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies for managing high blood pressure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that checking blood pressure from home, a key part of the treatments being tested, is generally safe for people with high blood pressure. Studies have found that this method helps manage blood pressure better by using home devices for regular readings. Many find it easy because they can check their blood pressure at home instead of at a doctor's office.

A thorough review suggests that the high-intensity and one-time training approach, which includes home monitoring, can greatly improve blood pressure control without major safety concerns. Participants in past studies reported that regular feedback and reminders were easy to manage.

The high-intensity and practice facilitation approach also appears safe. Research shows that regular coaching and support, along with home monitoring, have been successfully used to manage blood pressure. Patients in these studies usually found the ongoing support helpful and without major side effects.

Similarly, the standard and practice facilitation method, which includes regular coaching, has shown positive results in safely managing blood pressure. Home monitoring in these cases has not been linked to significant negative effects. Instead, it often leads to more accurate blood pressure readings and better overall control.

Overall, available evidence suggests that these home monitoring strategies are safe for people with high blood pressure, with no significant safety issues reported in related studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the remote monitoring strategies for high blood pressure because they offer personalized and proactive approaches that could make managing this condition more effective. Unlike traditional treatments that often rely solely on medication and occasional clinic visits, these strategies provide continuous feedback and coaching. The high-intensity strategies are particularly promising, offering personalized patient feedback and either one-time training or ongoing coaching for clinics, potentially leading to more tailored and responsive care. This proactive approach could help patients maintain better blood pressure control with more regular and personalized support.

What evidence suggests that this trial's treatments could be effective for improving blood pressure control in patients with hypertension?

Research has shown that remote patient monitoring (RPM) effectively manages high blood pressure. This trial will compare different RPM strategies, including "High-intensity and One-time Training," "High-intensity and Practice Facilitation," "Standard and One-time Training," and "Standard and Practice Facilitation." Studies have found that RPM helps patients control their blood pressure better than usual care. This approach allows continuous tracking and personalized feedback, making it easier to maintain healthy blood pressure levels over time. RPM has been linked to better results in several studies, including those involving minority and low-income groups. With regular monitoring and support, patients often see significant improvements in managing their blood pressure. ^{3 6 7 8 9}

Who Is on the Research Team?

Urmimala Sarkar

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults who can read and write in English or Spanish, have high blood pressure (at least 140/90 mmHg on two occasions in the past 18 months), and are able to consent. It's not for pregnant or nursing individuals, those on dialysis, or with disabilities that limit self-management.

Inclusion Criteria

My sex or gender does not limit my participation.

I have high blood pressure measured at 140/90 or higher twice in the last 18 months.

Any race or ethnicity

Exclusion Criteria

We will exclude individuals with conditions that might have severe self-management limitations due to a disability or medical condition or might complicate remote BP monitoring, such as self-reported lactating/nursing

We will exclude individuals with conditions that might have severe self-management limitations due to a disability or medical condition or might complicate remote BP monitoring, such as self-reported dialysis

We will exclude individuals with conditions that might have severe self-management limitations due to a disability or medical condition or might complicate remote BP monitoring, such as self-reported pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized feedback and training or coaching to improve blood pressure control

6 months

Regular visits (virtual and in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-intensity and One-time Training
• High-intensity and Practice Facilitation
• Standard and One-time Training
• Standard and Practice Facilitation

Trial Overview The study compares different strategies to manage high blood pressure using remote monitoring. Patients will receive either standard care with one-time training, intensive support with practice facilitation, standard care plus facilitation, or intensive support with just training.

How Is the Trial Designed?

Group I: Standard and Practice Facilitation Experimental Treatment 1 Intervention

Patient level: Standard, automatic reminders Clinic level: Regular, ongoing coaching

Group II: High-intensity and Practice Facilitation Experimental Treatment 1 Intervention

Patient level: Personalized feedback Clinic level: Regular, ongoing coaching

Group III: High-intensity and One-time Training Experimental Treatment 1 Intervention

Patient level: Personalized feedback Clinic level: One-time training

Group IV: Standard and One-time Training Active Control 1 Intervention

Patient level: Standard, automatic reminders Clinic level: One-time training

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

The study demonstrated that an intensive mobile blood pressure management strategy is feasible for acute ischemic stroke patients, with 95% of participants completing the final visit and high adherence to blood pressure measurement criteria (91% in the intensive group).

No adverse events related to the trial procedures were reported, indicating that the remote monitoring approach is safe for patients, although improvements to the device are needed before larger trials can be conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote blood pressure monitoring and behavioral intensification for stroke: A randomized controlled feasibility trial. Kim, BJ., Park, JM., Park, TH., et al.[2020]

Home blood pressure monitoring (HBPM) is recommended as a routine practice for most patients with known or suspected hypertension, as it provides more accurate and reproducible readings compared to traditional office measurements, helping to better predict cardiovascular risk.

Patients should use validated oscillometric monitors for HBPM, taking multiple readings over a week to inform clinical decisions, which can also aid in distinguishing between white-coat and sustained hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Call to action on use and reimbursement for home blood pressure monitoring: executive summary a joint scientific statement from the american heart association, american society of hypertension, and preventive cardiovascular nurses association. Pickering, TG., Miller, NH., Ogedegbe, G., et al.[2010]

Home blood pressure monitoring (HBPM) is recommended as a routine practice for most patients with hypertension, as it provides more accurate and reproducible readings compared to traditional office measurements, helping to better predict cardiovascular risk.

Patients should use validated oscillometric monitors for HBPM, taking multiple readings over a week to inform clinical decisions, which can improve treatment adherence and overall blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Call to action on use and reimbursement for home blood pressure monitoring: a joint scientific statement from the American Heart Association, American Society of Hypertension, and Preventive Cardiovascular Nurses Association. Pickering, TG., Miller, NH., Ogedegbe, G., et al.[2022]

Remote monitoring of blood pressure using telemedicine technology can significantly improve the management of arterial hypertension, leading to better control of blood pressure levels in patients.

Implementing remote monitoring in Russia has shown promising results in achieving target blood pressure levels, which could ultimately reduce emergency care visits and lower the risk of serious cardiovascular events like strokes and heart attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Realities and prospects of remote blood pressure monitoring in hypertensive patients. Boytsov, SA.[2019]

Home blood pressure monitoring (HBPM) is recommended as a routine practice for most patients with hypertension, as it provides more accurate and reproducible readings compared to traditional office measurements, helping to better predict cardiovascular risk.

Patients should use validated oscillometric monitors for HBPM, taking multiple readings over a week to inform clinical decisions, which can also enhance treatment adherence and improve overall care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Call to action on use and reimbursement for home blood pressure monitoring: Executive Summary. A joint scientific statement from the American Heart Association, American Society of Hypertension, and Preventive Cardiovascular Nurses Association. Pickering, TG., Miller, NH., Ogedegbe, G., et al.[2021]

In a pilot trial involving 132 participants with hypertension, a remote blood pressure monitoring system led to a significant reduction in mean blood pressure from 137/85 to 132/78 mmHg over an average follow-up of 487 days.

The percentage of subjects achieving controlled blood pressure (<140/90 mmHg) increased from 47% to 66%, indicating the potential effectiveness of this monitoring system in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot test of a new tool for remote blood pressure monitoring. Boman, K., Brenander, A., Gustavsson, M., et al.[2019]

Ambulatory blood pressure monitoring is essential for managing hypertension, and home monitoring is preferred by patients, highlighting the importance of patient-centered approaches in treatment.

Despite the rise of smartphone apps for blood pressure monitoring, only two apps align with European Society of Hypertension guidelines, indicating a need for better collaboration between tech developers and healthcare professionals to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure measurement and digital health: communication technologies create a new context. Postel-Vinay, N., Bobrie, G., Savard, S., et al.[2019]

In a study of 374 hypertensive patients, remote patient monitoring, with or without physician care, was found to be as effective as traditional office care in reducing blood pressure over 24 weeks.

Patients over 55 years old showed significant improvements in blood pressure with remote monitoring, indicating that this approach can be beneficial for older adults managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial to assess the effectiveness of remote patient monitoring and physician care in reducing office blood pressure. Kim, YN., Shin, DG., Park, S., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11353537/

Remote Patient Monitoring Is Associated with Improved ... RPM is associated with improved HTN control and provides further evidence supporting telehealth programs which can aid in chronic disease management.

2. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-025-04278-6

Efficiency of remote monitoring and guidance in blood ... In this study, we aimed to compare whether remote monitoring and self-monitoring differ from usual care in terms of their effects on BP ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838320

Lessons From a Remote Blood Pressure Monitoring Trial The findings of Mehta et al not only show that BP monitoring can be effectively integrated into routine clinical workflows to improve BP control ...

4. healthsnap.io healthsnap.io/the-impact-of-virtual-care-management-programs-on-hypertension-outcomes-in-2024/

The Impact of Virtual Care Management Programs on ... Continuous monitoring helps in maintaining optimal blood pressure levels over extended periods, thereby reducing the risk of long-term ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000287032500122X

Trial Designs Implementing remote patient monitoring to ... The Monitor-BP Trial tests a scalable approach to implementing telemonitoring-enabled Supported HBPM interventions into real-world clinical settings.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9903197/

Is remote blood pressure monitoring and management a ... Their results suggest that telemetric blood pressure monitoring may help in the management and improvement of hypertension during pregnancy, ...

7. academic.oup.com academic.oup.com/ajh/advance-article/doi/10.1093/ajh/hpaf097/8154826

Remote Blood Pressure Monitoring: A Comprehensive Review Remote BP monitoring can allow for better representation of BP and BP trends through longitudinal, high-quality out-of-office measurements, ...

8. psnet.ahrq.gov psnet.ahrq.gov/perspective/remote-patient-monitoring

Remote Patient Monitoring | PSNet RPM is a type of telehealth in which healthcare providers monitor patients outside the traditional care setting using digital medical devices.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2542454825000402

Developing and Deploying a Hypertension Remote Patient ... Remote patient monitoring (RPM) programs are quickly emerging as essential tools to monitor and improve BP control outside the office while solving many of the ...