930 Participants Needed

Self-Measured Blood Pressure Monitoring for High Blood Pressure

Recruiting at 1 trial location
KK
Overseen ByKorey Kennelty, PharmD, PhD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Korey Kennelty
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether self-monitoring blood pressure at home, with or without pharmacist assistance, can better control high blood pressure in older adults. It targets individuals with multiple ongoing health conditions who are not in nursing homes or hospice care. Patients with high blood pressure readings over the past six months and who plan to remain with their current healthcare provider for the next two years may be suitable candidates. The trial will track changes in blood pressure and assess how managing treatment impacts daily life. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance blood pressure management for many.

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 medications, as the study focuses on self-measured blood pressure monitoring.

What prior data suggests that self-measured blood pressure monitoring is safe for older adults with multiple chronic conditions?

Research has shown that checking blood pressure at home is generally safe and helpful, allowing individuals to manage high blood pressure more easily. Studies suggest that involving a pharmacist can enhance this process. As a result, people can control their blood pressure more effectively without major side effects.

For example, when individuals use home blood pressure monitoring with a pharmacist's assistance, many experience a reduction in blood pressure. This method is safe and effective for most people. Pharmacists can provide advice and regular check-ins to ensure everything proceeds smoothly.

While no major safety concerns exist, each person's experience may vary. Discussing any concerns or side effects with a healthcare provider is important to ensure the best results while maintaining safety.12345

Why are researchers excited about this trial?

Researchers are excited about the trial of self-measured blood pressure monitoring (SMBP) with clinical pharmacist support because it empowers patients to take an active role in managing their high blood pressure. Unlike standard treatments that rely heavily on clinic visits and physician-led management, this approach integrates pharmacists who provide personalized support and guidance. This unique combination offers a more tailored approach to blood pressure management, potentially improving adherence to treatment plans and leading to better health outcomes. By involving pharmacists, patients can gain a deeper understanding of their condition and how to manage it effectively, which is a promising step towards more patient-centered care.

What evidence suggests that self-measured blood pressure monitoring with clinical pharmacist support could be effective for high blood pressure?

Research has shown that checking blood pressure at home, with support from healthcare professionals, can effectively lower blood pressure in individuals with hypertension. This trial assigns participants to different arms to evaluate the effectiveness of self-measured blood pressure (SMBP) monitoring. One arm involves SMBP with conventional clinical support, while another includes SMBP with clinical pharmacist support. Results tend to improve further when a pharmacist is involved. Monitoring blood pressure at home, combined with online communication and pharmacist support, has been shown to help manage high blood pressure. A nationwide program led by community pharmacists, which encourages home blood pressure monitoring, has also successfully controlled high blood pressure. These findings suggest that involving a pharmacist in home monitoring could be especially beneficial for older adults with multiple health issues.24678

Are You a Good Fit for This Trial?

This trial is for older adults with high blood pressure and multiple chronic diseases. It's designed to help those who may be at higher risk, including rural or Black older adults, even if they have dementia. Participants should be interested in monitoring their own blood pressure at home.

Inclusion Criteria

Patient has a baseline in-clinic visit systolic blood pressure (SBP) >= 140 mmHg
Patient plans to receive care from participating healthcare system for the next 24 months
I am 65 years old or older.
See 2 more

Exclusion Criteria

Patient is enrolled in hospice or has an active referral to hospice care
Patient resides in a nursing home, in skilled nursing, rehabilitation facility, or memory care
Patient does not have a telephone
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in self-measured blood pressure monitoring with either conventional clinical support or clinical pharmacist support

12 months

Follow-up

Participants are monitored for changes in systolic blood pressure and self-reported treatment burden

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • SMBP with clinical pharmacist support
Trial Overview The study tests if self-measured blood pressure (SMBP) monitoring at home can improve control of high blood pressure when supported by a clinical pharmacist compared to usual support. The main goal is to see changes in systolic BP over a year and how it affects patients' treatment burden.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: SMBP-pharmacistExperimental Treatment1 Intervention
Group II: SMBP-conventionalActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Korey Kennelty

Lead Sponsor

Trials
4
Recruited
1,300+

Published Research Related to This Trial

Self-measurement of blood pressure (SMBP) using validated automated devices provides reliable readings and is particularly useful for evaluating antihypertensive treatments, especially in cases of resistant hypertension and the white-coat effect.
SMBP not only enhances patient motivation and adherence to treatment but also improves the power of clinical trials, allowing researchers to detect smaller differences in blood pressure with fewer participants compared to traditional office measurements.
Self-measurement of blood pressure in clinical trials and therapeutic applications.Denolle, T., Waeber, B., Kjeldsen, S., et al.[2007]
A survey of 1,590 primary care physicians and nurse practitioners revealed that 97% use self-measured blood pressure monitoring (SMBP), primarily for both diagnosis and treatment, indicating its widespread acceptance as a tool for managing hypertension.
Despite the high usage of SMBP, there are notable gaps in best practices, such as patient counseling on cuff size and device validation, suggesting that improvements in these areas could enhance the effectiveness of SMBP in blood pressure control.
Clinical Implementation of Self-Measured Blood Pressure Monitoring, 2015-2016.Jackson, SL., Ayala, C., Tong, X., et al.[2021]
Self-measurement of blood pressure (SMBP) at home is an accurate method for diagnosing hypertension, showing higher specificity and predictive value compared to traditional office blood pressure measurements in a study of 64 untreated hypertensive patients.
The reproducibility of SMBP in standardized conditions is comparable to that of ambulatory blood pressure monitoring (ABPM), suggesting that with proper training, home measurements can be reliably used for hypertension diagnosis.
[Accuracy and precision in blood pressure measurement. Comparative study of home self-measurement with measurement in the clinic and out-patient monitoring].Divisón, J., Puras, A., Sanchis, C., et al.[2020]

Citations

Implementing Self-Measured Blood Pressure Monitoring ...Self-measured blood pressure monitoring (SMBP) with clinical support is effective at reducing blood pressure for people with hypertension.
SMBP Study: Improving High Blood Pressure in Older ...The addition of a pharmacist has been shown to improve patient outcomes, though the effectiveness of SMBP with a clinical pharmacist in older adults is not ...
Self-Measured Blood Pressure–Guided PharmacotherapyEffectiveness of home blood pressure monitoring, web communication, and pharmacist care on hypertension control: a randomized controlled trial.
Effectiveness of a nationwide community pharmacist-led ...Effectiveness of a nationwide community pharmacist-led program promoting home blood pressure monitoring on hypertension control and self- ...
Clinical impact of a tiered, pharmacist‐driven remote patient ...This study examined the impact of a tiered, non-physician SMBP program, engaging patients through a familiar communication medium to relay home BP readings.
Use of Self-Measured Blood Pressure Monitoring to ...The studies with clinical outcomes demonstrate that SMBP monitoring (a) can be successfully adopted by historically excluded patient populations and safety-net ...
Implementing Self-Measured Blood Pressure Monitoring ...Context: Self-measured blood pressure monitoring (SMBP) with clinical support is effective at reducing blood pressure for people with ...
Self-Measured Blood Pressure Monitoring (SMBP)SMBP helps with both diagnosis and management of hypertension and increases patient participation in their own care. SMBP, when combined with other clinical ...
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