Blood Pressure Management Technology for High Blood Pressure

Not currently recruiting at 1 trial location

Overseen By Wendy A Rogers, Ph.D.

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must be taking: Hypertension medications

Disqualifiers: Severe depression, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technology system for managing high blood pressure. Participants will split into two groups to determine if the Blood Pressure Technology System E or M aids in medication adherence and effective condition management. One group will receive additional strategies for medication and blood pressure management, while both groups will receive general information about high blood pressure. The trial seeks individuals aged 65 or older who use an Apple iPhone and have struggled with consistently taking their high blood pressure medication. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance blood pressure management for many.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it seems you will continue managing at least one hypertension medication during the study.

What prior data suggests that this blood pressure technology system is safe for managing high blood pressure?

Research shows that checking blood pressure at home is generally safe and easy. For Blood Pressure Technology System E, studies have found that digital tools effectively and safely manage high blood pressure. These tools allow users to track blood pressure over time from home, making management easier and more convenient.

For Blood Pressure Technology System M, research shows similar results. Measuring blood pressure at home is reliable and safe for regular monitoring. Using automated devices with an upper arm cuff is important, as recommended by the World Health Organization.

Both systems use technology that has been widely tested and used for managing high blood pressure. This results in a low risk of serious side effects, making these systems a safe choice for those managing high blood pressure at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Blood Pressure Technology Systems E and M because they offer a fresh approach to managing high blood pressure. Unlike traditional methods that often rely on medications alone, these systems provide users with comprehensive information about high blood pressure, including medication details and strategies for better medication adherence. This educational aspect empowers patients to take an active role in managing their condition, potentially leading to better outcomes. Additionally, the structured mid- and post-assessments at three and six months encourage ongoing engagement and adjustment, which could enhance long-term blood pressure control.

What evidence suggests that this blood pressure technology system is effective for managing high blood pressure?

Research shows that blood pressure monitoring systems, like those tested in this trial, can help people manage high blood pressure effectively. Participants will be assigned to one of two systems: Blood Pressure Technology System M or Blood Pressure Technology System E. Studies have found that using home blood pressure monitors with remote guidance can significantly lower blood pressure. One study found that remote monitoring improved patient health and reduced healthcare costs. For the Blood Pressure Technology System M, home monitoring has proven to be a reliable and convenient way to track blood pressure outside the doctor's office. Research also shows that checking blood pressure at home helps keep it under control better than usual care. Overall, these systems can make a real difference in managing high blood pressure. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 or over with high blood pressure who are not taking their hypertension medication as prescribed. Participants must be able to read and speak English, use an iPhone, manage at least one blood pressure medicine themselves, and commit to a six-month study period.

Inclusion Criteria

You didn't take your high blood pressure medicine at least 90% of the time for the last 2 weeks of the 4-week period when your medicine intake was monitored.

I currently own and use an Apple iPhone.

I take medication for high blood pressure by myself.

Exclusion Criteria

Your vision is worse than 20/50 even with glasses or contacts.

Been instructed by their healthcare provider to withhold their blood pressure medication

You have a high chance of having trouble with memory and thinking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the blood pressure technology system for 6 months, with mid-assessment at 3 months and post-assessment at 6 months

6 months

Mid-assessment at 3 months, post-assessment at 6 months

Follow-up

Participants are monitored for changes in adherence, blood pressure, perceived competence, autonomy, and mobile device proficiency

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blood Pressure Technology System E
• Blood Pressure Technology System M

Trial Overview The trial tests two different blood pressure technology systems in people who struggle with medication adherence. All participants receive high blood pressure education; half also get strategies for managing medications. They're checked after three months and again at the end of the study.

How Is the Trial Designed?

Group I: Blood Pressure Technology System M Experimental Treatment 1 Intervention

These participants will receive information about high blood pressure, medications and strategies that can be used to take medications and manage blood pressure. They will complete a mid-assessment at 3-months and a post-assessment at 6-months.

Group II: Blood Pressure Technology System E Experimental Treatment 1 Intervention

These participants receive information about high blood pressure and medications. They will complete a mid-assessment at 3-months and a post-assessment at 6-months.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

University of Illinois at Urbana-Champaign

Collaborator

Trials

203

Recruited

40,600+

Published Research Related to This Trial

A study of 452 hypertensive patients in Turkey revealed that most patients chose their home sphygmomanometers based on simplicity and ease of use, rather than on their accuracy or validation status.

None of the patients were aware of whether their home sphygmomanometers were validated or calibrated, indicating a significant gap in knowledge that could lead to inaccurate blood pressure readings and potential mismanagement of hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do we measure blood pressure at home? Bardak, S., Turgutalp, K., Özcan, T., et al.[2015]

Blood pressure telemonitoring (BPT) is a leading e-health tool that significantly reduces blood pressure in patients, especially high-risk individuals, when combined with remote counseling and medication management.

E-health solutions like BPT enhance patient self-management and engagement in their care, leading to better blood pressure control and improved adherence to medication regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connected Health in Hypertension Management. Omboni, S.[2023]

The smartphone-based blood pressure monitoring system using photoplethysmography (PPG) technology demonstrated over 90% accuracy in predicting blood pressure values, making it a promising tool for self-monitoring hypertension, especially for elderly users.

While the system showed strong correlation and usability, only the diastolic blood pressure predictions met clinical accuracy standards, indicating that further development is needed to enhance its reliability for both systolic and diastolic measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Personal Health Care System for Noninvasive, Pervasive, and Continuous Blood Pressure Monitoring: Development and Usability Study. Mena, LJ., Félix, VG., Ostos, R., et al.[2021]

Home blood pressure monitoring (HBPM) and 24-hour ambulatory blood pressure monitoring (ABPM) show similar effectiveness in controlling blood pressure and improving patient outcomes, based on a systematic review of 19 relevant studies.

HBPM is associated with better detection of optimal blood pressure control compared to office blood pressure monitoring, suggesting its routine use in clinical practice to enhance patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does home blood pressure monitoring improve patient outcomes? A systematic review comparing home and ambulatory blood pressure monitoring on blood pressure control and patient outcomes. Breaux-Shropshire, TL., Judd, E., Vucovich, LA., et al.[2022]

Blood pressure telemonitoring (BPT) has been shown to significantly reduce blood pressure in high-risk hypertensive patients compared to usual care, especially when supervised by healthcare professionals.

Mobile health (m-health) solutions, including health tracking apps, empower patients to manage their hypertension more actively, enhancing their involvement in medical decision-making and potentially improving overall care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine and M-Health in Hypertension Management: Technologies, Applications and Clinical Evidence. Omboni, S., Caserini, M., Coronetti, C.[2018]

In a study involving 100 Alaska Native and American Indian participants with hypertension, the majority (66%) preferred wrist blood pressure monitoring devices over arm devices due to higher ratings in ease of use and comfort.

Despite valuing accuracy in home blood pressure monitoring, participants prioritized usability factors like comfort and ease of use when choosing a device, indicating that these characteristics are crucial for long-term management of hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choice of home blood pressure monitoring device: the role of device characteristics among Alaska Native and American Indian peoples. Railey, AF., Dillard, DA., Fyfe-Johnson, A., et al.[2023]

Blood pressure telemonitoring (BPT) has strong evidence supporting its effectiveness in screening, diagnosing, and managing hypertension, especially when combined with interventions from healthcare professionals and education on lifestyle changes.

BPT can lead to improved treatment compliance, better blood pressure control, enhanced quality of life, and potential cost savings, indicating it may significantly transform hypertension management in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-Health in Hypertension Management: an Insight into the Current and Future Role of Blood Pressure Telemonitoring. Omboni, S., Panzeri, E., Campolo, L.[2020]

A study involving 236 hypertensive patients found that antihypertensive treatment guided by telemonitoring of home blood pressure was as effective as traditional office-based monitoring in reducing systolic daytime blood pressure over 6 months.

Both groups experienced significant decreases in blood pressure, with the telemonitoring group showing a reduction of -11.9 mmHg compared to -9.6 mmHg in the control group, indicating that home monitoring can be a viable alternative for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure control during telemonitoring of home blood pressure. A randomized controlled trial during 6 months. Madsen, LB., Kirkegaard, P., Pedersen, EB.[2008]

In a trial involving 62 older adults with hypertension, the MyBP digital tool showed high engagement rates (82.7%) for home blood pressure monitoring, indicating its feasibility for routine use.

While overall blood pressure reductions were similar between MyBP and control groups, those with higher initial systolic blood pressure in the MyBP group experienced greater declines, suggesting potential clinical benefits for specific patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized feasibility trial of a digital intervention for hypertension self-management. Muldoon, MF., Einhorn, J., Yabes, JG., et al.[2023]

Out-of-office blood pressure monitoring, including home and ambulatory methods, provides more accurate and comprehensive data for managing hypertension compared to traditional office measurements, helping to identify conditions like white-coat and masked hypertension.

Home blood pressure monitoring has been shown to improve long-term control of hypertension by enhancing patient adherence to treatment, and it is recommended by guidelines in multiple countries for confirming hypertension diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for home blood pressure monitoring in Latin American countries: A Latin American Society of Hypertension position paper. Villar, R., Sánchez, RA., Boggia, J., et al.[2021]

Home blood pressure monitoring (HBPM) is an effective self-monitoring tool for managing hypertension, leading to better blood pressure control and helping to identify conditions like white-coat hypertension, as supported by a growing body of evidence.

New HBPM technology features a longer inflatable cuff that improves accuracy by allowing for better placement on the arm, addressing the common issue of inaccurate readings in traditional monitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Blood Pressure Monitoring. George, J., MacDonald, T.[2022]

Citations

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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 ...

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Management of Hypertension in the Digital Era Wearable blood pressure monitors allow frequent blood pressure measurements (ideally continuous beat-by-beat monitoring of blood pressure) with minimal stress ...

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

The Impact of Virtual Care Management Programs on ... The ability to monitor blood pressure remotely not only improves patient outcomes but also leads to significant cost savings for healthcare ...

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Novel Digital Technologies for Blood Pressure Monitoring and ... This paper reviews existing and emerging digital tools available for hypertension management, as well as behavioral economic insights that could supercharge ...

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The 2020 “WHO Technical Specifications for Automated ... A recent World Health Organization report has outlined the technical specifications for automated noninvasive clinical BP measurement with cuff.

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Electronic Communications and Home Blood Pressure ... The Electronic Communications and Home Blood Pressure Monitoring (e-BP) study is a three-arm randomized controlled trial designed to determine whether care ...

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Why Home Blood Pressure Monitoring is The Gold ... Home blood pressure monitoring provides actionable BP data obtained under pre-determined conditions and timeframes over an extended time period.

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Home Blood Pressure Telemonitoring Technology for Patients ... HBPT intervention is a feasible postdischarge management strategy and can be beneficial in supporting patients with asymptomatic elevated BP from the ED.