Home Blood Pressure Monitoring for High Blood Pressure

Recruiting at 34 trial locations

Overseen By Teresa Pitre

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Oral contraceptives

Disqualifiers: Male, Hypertensive emergency, Pregnancy, others

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

Compensation: Varies

Number of Visits: 56

Duration: 24 weeks

368 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether checking blood pressure at home, combined with pharmacist care, helps women manage high blood pressure more effectively than usual care. It compares two groups: one using home monitors with regular pharmacist advice (enhanced community pharmacist care) and another receiving standard pharmacist care. The trial seeks women with high blood pressure readings, diagnosed or not, who do not already use a home blood pressure monitor.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance blood pressure management for women.

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 seems likely that you can continue your current treatment, as the study involves monitoring blood pressure and pharmacist care.

What prior data suggests that home blood pressure monitoring is safe for women with elevated blood pressure?

Research shows that checking blood pressure at home is generally safe and easy for most people. Studies have found that using a home blood pressure monitor can help avoid the "white-coat" effect, where anxiety at the doctor's office might raise blood pressure. This makes home monitoring a reliable way to track blood pressure over time.

Additionally, research indicates that when pharmacists assist patients with these monitors, it leads to better blood pressure control. This means the process is not only safe but also effective in managing blood pressure.

The extra support from pharmacists, combined with home monitoring, has improved blood pressure control more than usual care alone. No major reports of problems have emerged from using home blood pressure monitors, making this a safe option for managing high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how home blood pressure monitoring, combined with enhanced pharmacist care, can improve blood pressure management. Unlike the usual approach where pharmacists provide general advice, this method allows patients to monitor their blood pressure at home and share their readings with pharmacists through a data system called REDCap. This continuous monitoring and feedback loop could lead to more personalized and timely adjustments in treatment, potentially improving blood pressure control. This trial aims to find out if this proactive and collaborative care model can lead to better outcomes compared to standard pharmacy visits and advice.

What evidence suggests that home blood pressure monitoring in addition to pharmacist care could be effective for high blood pressure?

This trial will compare different approaches to managing high blood pressure. Participants in one arm will receive pharmacist care along with home blood pressure monitoring. Studies have shown that home monitoring and pharmacist assistance can greatly improve blood pressure control. Research indicates that individuals who monitor their blood pressure at home and receive follow-up care from a pharmacist manage their blood pressure better than those receiving standard care. Another arm of this trial involves usual pharmacist care without home monitoring. One analysis found that pharmacist-assisted home monitoring yields better results than usual care alone. Another study showed that online pharmacist support combined with home monitoring increased the number of people who maintained blood pressure control. Overall, these findings suggest that this combined approach can effectively manage high blood pressure. ^{1 3 5 6 7}

Who Is on the Research Team?

Ross Tsuyuki, PharmD MSc

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for women with high blood pressure who haven't been diagnosed or treated for hypertension, except those with diabetes where a lower BP threshold applies. Participants should have a systolic BP of at least 140 mmHg or diastolic BP of at least 90 mmHg, or at least 130/80 mmHg if diabetic.

Inclusion Criteria

I have been diagnosed with or am being treated for high blood pressure.

I have never been diagnosed or treated for high blood pressure.

If you have diabetes, your Systolic Blood Pressure (SBP) must be at least 130 mmHg and/or Diastolic Blood Pressure (DBP) must be 80 mmHg or greater.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pharmacist care with home blood pressure monitoring or usual care for 24 weeks

24 weeks

Baseline, every 4 weeks, and final follow-up at 24 weeks

Follow-up

Participants are monitored for ongoing use of home blood pressure monitor and BP management by the prescribing clinician

28 weeks

Final follow-up at 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced community pharmacist care
• Home blood pressure monitor
• Usual pharmacist care

Trial Overview

The study tests whether home blood pressure monitoring plus pharmacist care improves blood pressure control compared to usual pharmacist care alone in women. It's a randomized controlled trial where half the participants will use home monitors and get enhanced pharmacy services, while the other half receives standard care.

How Is the Trial Designed?

Group I: Pharmacist care in conjunction with home blood pressure monitoring Experimental Treatment 2 Interventions

Patients will have BP assessed at baseline in the pharmacy by the pharmacist, and they will receive a home blood pressure monitor in addition to education and counselling provided by the pharmacist. Patients will measure their BP at home for seven days every four weeks and input their results into a data management system called REDCap that is accessible by the pharmacist. The pharmacist will follow up with the patient every 4 weeks to review their readings and at 24-weeks the patient will come into the pharmacy for a final follow-up and BP readings. The pharmacist will fax BP readings as well as suggestions for therapy modification to the patient's prescribing clinician. Patients will then have their care returned to their prescribing clinician with no pharmacist specific interventions outside of usual pharmacy care activities and have a single follow-up at month-12 with the pharmacist reviewing home BP monitor use and reporting of data to prescribing clinician.

Group II: Usual pharmacist care Active Control 1 Intervention

Patients will have BP assessed at baseline, 12-, and 24-weeks in the pharmacy by the pharmacist. Patients will not receive a home blood pressure monitor. Pharmacist will provide them usual care, education and counselling on BP management. Pharmacists will fax BP readings to the patient's prescribing clinician but will not provide any suggestions for therapy modification. After 24-weeks patients will be offered a home blood pressure monitor with education on its use. They will then be offered to crossover to the intervention group for the next 6-months or have their care returned to their prescribing clinician with no pharmacist specific interventions outside of usual pharmacy care activities and have a single follow-up at month-12 with the pharmacist reviewing home BP monitor use and reporting of data to prescribing clinician.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

A collaborative healthcare model involving a physician, nurse, and community pharmacist can enhance the effectiveness and adherence to anti-hypertensive therapy, as shown in randomized controlled trials.

Utilizing blood pressure telemonitoring strengthens the relationship between healthcare professionals and patients, leading to better blood pressure control and personalized management of hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacist and the management of arterial hypertension: the role of blood pressure monitoring and telemonitoring. Omboni, S., Sala, E.[2020]

In a study of 1026 hypertensive patients, 45% owned a home blood pressure monitoring (HBPM) device, but overall, there was no significant difference in medication adherence between those who used HBPM and those who did not.

However, patients who followed the recommended 'rule of 3' for HBPM reported better adherence to their medication, highlighting the importance of proper education from general practitioners on how to effectively use HBPM devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure monitoring and adherence in patients with hypertension on primary prevention treatment: a survey of 1026 patients in general medicine in the Auvergne region. Trefond, J., Hermet, L., Lambert, C., et al.[2022]

A 22-year-old male with previously noted high blood pressure used a home telemonitoring system for 28 days, which revealed higher nighttime systolic blood pressure compared to daytime levels.

This case highlights the effectiveness of blood pressure telemonitoring in a community pharmacy setting, leading to further medical evaluation and the detection of nocturnal hypertension, demonstrating its potential for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of pharmacist blood pressure telemonitoring systems in diagnosis of nocturnal hypertension in a young healthy male. Mizuno, T., Matsumoto, C., Nabetani, N., et al.[2021]

Implementing Home Blood Pressure Monitoring (HBPM) with a clinical pharmacist team can significantly improve blood pressure control, and the study outlines strategies like patient outreach and automated texting to enhance participation and effectiveness.

The study will assess the impact of these strategies on hypertension control and equity using a stepped wedge randomized trial, focusing on various outcomes such as patient engagement and sustained blood pressure management over twelve months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team-based home blood pressure monitoring for blood pressure equity a protocol for a stepped wedge cluster randomized trial. Fiscella, KA., Sass, E., Sridhar, SB., et al.[2023]

The study found that implementing home blood pressure monitoring and pharmacist-managed care for hypertension resulted in lower average medical costs per person, by about $281, although this difference was not statistically significant.

The intervention demonstrated cost-effectiveness, costing approximately $7337 per person to achieve hypertension control, suggesting that such programs can improve blood pressure management without increasing overall healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic Evaluation of the Home Blood Pressure Telemonitoring and Pharmacist Case Management to Control Hypertension (Hyperlink) Trial. Dehmer, SP., Maciosek, MV., Trower, NK., et al.[2022]

A community pharmacist-based home blood pressure monitoring program showed that a high-intensity intervention led to a greater reduction in diastolic blood pressure (DBP) compared to a low-intensity intervention, with a decrease of 3.2 mmHg (P=0.03).

The high-intensity group, which involved more personalized education and home monitoring, resulted in a significant decline in systolic blood pressure (SBP) by 13.4 mmHg, compared to a 9.0 mmHg decline in the low-intensity group, suggesting that more intensive pharmacist involvement can be beneficial for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension outcomes through blood pressure monitoring and evaluation by pharmacists (HOME study). Zillich, AJ., Sutherland, JM., Kumbera, PA., et al.[2022]

A study involving 50 participants found significant differences in blood pressure readings between a community-based blood pressure monitor (CBPM) and a validated automatic blood pressure monitor (ABPM), which could lead to different treatment recommendations for 38% of participants.

Primary care providers often recommend CBPMs for self-monitoring, highlighting the need for awareness of potential inaccuracies in these devices to ensure proper blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of community-based blood pressure devices versus validated self-use devices. Karr, S., Gurney, MK., Early, NK.[2015]

Citations

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nature.com

nature.com/articles/s41440-025-02422-6

Effectiveness of a nationwide community pharmacist-led ...

A nationwide hybrid intervention promoting HBPM via community pharmacist-led case management resulted in substantial enhancements in BP control ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2715866/

Effectiveness of Home Blood Pressure Monitoring, Web ...

Treating hypertension decreases mortality and disability from cardiovascular disease; but most hypertension remains inadequately controlled.

3.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/1028642

Effectiveness of Home Blood Pressure Monitoring, Web ...

Adding Web-based pharmacist care to home BP monitoring and Web training significantly increased the percentage of patients with controlled BP ( ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002914923005155

Adding Pharmacist-Led Home Blood Pressure ...

This meta-analysis showed that adding pharmacist-led home BP telemonitoring to usual care achieves better BP control than usual care alone.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12399858/

Pharmacist-Led Digital Health Interventions to Improve ...

Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial.

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withpower.com

withpower.com/trial/phase-hypertension-8-2023-87c70

Home Blood Pressure Monitoring for High Blood Pressure

This N/A medical study run by University of Alberta is evaluating whether Enhanced community pharmacist care, Home blood pressure monitor and Usual ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4311883/

Effect of Home Blood Pressure Telemonitoring and ...

Home BP telemonitoring and pharmacist case management achieved better BP control compared to usual care during 12 months of intervention, and benefits ...