Home Blood Pressure Monitoring for High Blood Pressure

Recruiting at 31 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

Trial Summary

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 data supports the effectiveness of the treatment Enhanced community pharmacist care for high blood pressure?

Research shows that involving community pharmacists in home blood pressure monitoring can improve blood pressure control and medication adherence. Studies indicate that this approach, especially when combined with telemonitoring, enhances the relationship between patients and healthcare providers, leading to better management of high blood pressure. ^{1 2 3 4 5}

Is home blood pressure monitoring safe for humans?

Home blood pressure monitoring, often involving pharmacists, is generally considered safe for humans. Studies have shown that it can improve blood pressure control and enhance the relationship between patients and healthcare providers without indicating any specific safety concerns. ^{1 2 3 5 6}

How is the treatment 'Enhanced community pharmacist care with home blood pressure monitoring' different from other treatments for high blood pressure?

This treatment is unique because it involves a team-based approach where community pharmacists play a key role in managing high blood pressure through home monitoring and telemonitoring systems. This collaborative model enhances patient care by providing personalized and preventive management, which can improve blood pressure control and patient adherence compared to standard care. ^{1 2 3 6 7}

What is the purpose of this trial?

To evaluate the impact of home blood pressure monitoring when used in addition to pharmacist care, compared to usual care, in women with elevated blood pressure (BP). Randomized 1:1 two-arm controlled trial. Patients to be identified and screened by pharmacists. Patients with a BP \>140/90mmHg or \>130/80mmHg in those with diabetes will be invited to enroll in the study. Intervention: Patients will have BP assessed at baseline by the pharmacist, and they will receive a home blood pressure monitor in addition to 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. 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 and suggestions for therapy modification to the patient's prescribing clinician. After 24-weeks patient care is returned to the prescribing clinician with no further pharmacist interventions except for a final post-trial follow-up at week-52 to review ongoing home BP monitor use and BP management by the prescribing clinician. Control: 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 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 24-weeks or have their care returned to their prescribing clinician with no pharmacist specific interventions except for a final post-trial follow-up at week-52 to review ongoing home BP monitor use and BP management by the prescribing clinician. Sample Size: Calculated sample size is 368 participants to achieve 80% power, with 184 patients in the intervention and control groups. Primary Outcome: Difference in change in Systolic Blood Pressure between the home blood pressure monitoring in addition to pharmacist care versus usual care group.

Research Team

Ross Tsuyuki, PharmD MSc

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

References

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

Hypertension outcomes through blood pressure monitoring and evaluation by pharmacists (HOME study). [2022]

2. England pubmed.ncbi.nlm.nih.gov

The pharmacist and the management of arterial hypertension: the role of blood pressure monitoring and telemonitoring. [2020]

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

Economic Evaluation of the Home Blood Pressure Telemonitoring and Pharmacist Case Management to Control Hypertension (Hyperlink) Trial. [2022]

4. England 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. [2022]

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

Accuracy of community-based blood pressure devices versus validated self-use devices. [2015]

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

Team-based home blood pressure monitoring for blood pressure equity a protocol for a stepped wedge cluster randomized trial. [2023]

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

Use of pharmacist blood pressure telemonitoring systems in diagnosis of nocturnal hypertension in a young healthy male. [2021]