Blood Pressure Management Technology for High Blood Pressure

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

224 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized controlled trial will assess the efficacy and scalability of a blood pressure technology system intervention. The investigators will enroll 224 older adults with hypertension to identify those who are nonadherent for one hypertension medication. The participants will be randomized to one of two groups (112 per group) to use the blood pressure system for 6-months. Both groups receive information about high blood pressure and medications. One group will also receive strategies that can be used to take medications and manage blood pressure. Both groups will complete a mid-assessment at 3-months and a post-assessment at 6-months.

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 data supports the effectiveness of the treatment Blood Pressure Management Technology for High Blood Pressure?

Research shows that home blood pressure monitoring and telemonitoring systems can improve blood pressure control and patient outcomes by allowing for continuous and remote tracking of blood pressure, which helps in better diagnosis and management of hypertension (high blood pressure). These systems are effective in improving long-term hypertension control rates by enhancing patients' adherence to treatment. ^{1 2 3 4 5}

Is home blood pressure monitoring safe for humans?

Home blood pressure monitoring (HBPM) is generally considered safe for humans and is recommended for managing high blood pressure. However, it's important to ensure that the devices used are validated for accuracy, as some monitors may give incorrect readings. ^{5 6 7 8 9}

How is the Blood Pressure Technology System E and M treatment different from other treatments for high blood pressure?

The Blood Pressure Technology System E and M treatment is unique because it uses smartphone-based monitoring and telemedicine to allow patients to track their blood pressure at home, providing continuous and noninvasive monitoring. This approach empowers patients to manage their condition more effectively and can lead to better blood pressure control compared to traditional office-based monitoring. ^{1 6 8 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Mobile Personal Health Care System for Noninvasive, Pervasive, and Continuous Blood Pressure Monitoring: Development and Usability Study. [2021]

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

Recommendations for home blood pressure monitoring in Latin American countries: A Latin American Society of Hypertension position paper. [2021]

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

E-Health in Hypertension Management: an Insight into the Current and Future Role of Blood Pressure Telemonitoring. [2020]

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

Blood pressure control during telemonitoring of home blood pressure. A randomized controlled trial during 6 months. [2008]

5. New Zealand 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Home Blood Pressure Monitoring. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Choice of home blood pressure monitoring device: the role of device characteristics among Alaska Native and American Indian peoples. [2023]

8. England pubmed.ncbi.nlm.nih.gov

How do we measure blood pressure at home? [2015]

9. England pubmed.ncbi.nlm.nih.gov

Randomized feasibility trial of a digital intervention for hypertension self-management. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Connected Health in Hypertension Management. [2023]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Telemedicine and M-Health in Hypertension Management: Technologies, Applications and Clinical Evidence. [2018]