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

2500 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare the effectiveness of evidence-based, adapted, and tailored, patient-focused and clinic-focused strategies to improve blood pressure (BP) control in English- and Spanish-speaking patients with hypertension (HTN).

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.

What data supports the effectiveness of the treatment Remote Monitoring Strategies for High Blood Pressure?

Research shows that remote monitoring of blood pressure can be as effective as regular office visits in managing high blood pressure, especially for older adults. It can help more people reach their target blood pressure levels, which may reduce the risk of heart-related problems. ^{1 2 3 4 5}

Is remote monitoring for high blood pressure safe for humans?

Remote monitoring of blood pressure is generally considered safe and has been shown to improve the management of high blood pressure by allowing more accurate and frequent measurements at home. This method is endorsed by health organizations and is seen as reliable and easy to use. ^{2 6 7 8 9}

How does the Remote Monitoring Strategies for High Blood Pressure treatment differ from other treatments?

This treatment is unique because it uses remote monitoring technology to track blood pressure, allowing for more frequent and convenient monitoring compared to traditional in-person visits. This approach can improve blood pressure control and patient adherence to treatment, potentially reducing the risk of cardiovascular events. ^{2 3 10 11 12}

Research Team

Urmimala Sarkar

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial to assess the effectiveness of remote patient monitoring and physician care in reducing office blood pressure. [2018]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Remote Monitoring of Blood Pressure in Management of Urban Hypertensive Patients: A Systematic Review and Meta-Analysis. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Impact of remote patient monitoring on clinical outcomes: an updated meta-analysis of randomized controlled trials. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Understanding Moderators of Home Blood Pressure Telemonitoring Systems in Urban Hypertensive Patients: A Systematic Review and Meta-Analysis. [2021]

6. United States 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. [2022]

7. United States 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. [2010]

8. United States 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. [2021]

9. United States 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

A pilot test of a new tool for remote blood pressure monitoring. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Home blood pressure measurement and digital health: communication technologies create a new context. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Remote blood pressure monitoring and behavioral intensification for stroke: A randomized controlled feasibility trial. [2020]