Self-Measured Blood Pressure Monitoring for High Blood Pressure

Overseen By Korey Kennelty, PharmD, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Korey Kennelty

Disqualifiers: Hospice, Nursing home, Chemotherapy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

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

What data supports the effectiveness of the treatment SMBP with clinical pharmacist support for high blood pressure?

Research shows that self-measured blood pressure monitoring (SMBP) with clinical support is an effective way to control high blood pressure, as it empowers patients to manage their condition outside the clinic and improves blood pressure control. ^{1 2 3 4 5}

Is self-measured blood pressure monitoring (SMBP) safe for humans?

Self-measured blood pressure monitoring (SMBP) is generally considered safe for humans, as it involves using validated devices to measure blood pressure at home, which can help manage high blood pressure effectively. ^{1 2 3 6 7}

How is the treatment of self-measured blood pressure monitoring with clinical pharmacist support unique for high blood pressure?

This treatment is unique because it involves patients measuring their own blood pressure at home, which can lead to better control of high blood pressure by empowering patients and providing continuous monitoring outside the clinic. It also includes support from clinical pharmacists, which can enhance the effectiveness of the treatment by offering personalized guidance and adjustments. ^{1 2 3 5 8}

What is the purpose of this trial?

Nearly half of adults in the United States (47 percent, or 116 million) have hypertension, also known as high blood pressure (BP). Uncontrolled high BP can be devasting as it can lead to stroke, heart attack and kidney failure, as well as other numerous health conditions. Hypertension can be controlled; however, only one in four of adults with hypertension have their BP controlled. The chance of having high BP increases as one ages, requiring the need to examine effective hypertension strategies in older adults. The issue of hypertension management is compounded even further among older U.S. adults who live with multiple chronic diseases. National organizations identified several effective health systems strategies for improving rates of BP control, including patient self-measured blood pressure (SMBP) monitoring. SMBP involves a patient's regular use of personal BP monitoring devices to assess and record BP across different points in time, typically at home. The evidence base for utilizing SMBP strategies in healthcare systems and practices is strong. However, there is not research regarding SMBP including how to include it into workflow in primary care clinics. Previous research has shown SMBP is beneficial, but more information is needed regarding whether SMBP is beneficial in high-risk populations (such as rural, older adults or Black, older patients). The research team will test whether SMBP with normal clinical support vs SMBP with clinical pharmacist support improves BP in older adults living with multiple chronic conditions. 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 known. The primary outcome will be change in systolic BP over 12 months. The secondary outcome will be self-reported treatment burden over 12 months, using a validated tool called the Multimorbidity Treatment Burden Questionnaire. The research team plans to include a subgroup of rural, older adults and Black, older adults and will not exclude older adults who have dementia.

Eligibility Criteria

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: SMBP-pharmacist Experimental Treatment 1 Intervention

Self-measured blood pressure with clinical pharmacist support

Group II: SMBP-conventional Active Control 1 Intervention

Self-measured blood pressure with conventional clinical support

Who Is Running the Clinical Trial?

Korey Kennelty

Lead Sponsor

Trials

4

Recruited

1,300+

Findings from Research

A study involving 478 hypertensive patients at community health centers showed that after implementing self-measured blood pressure monitoring (SMBP), patient engagement in managing their blood pressure significantly increased, with 77% knowing their ideal blood pressure levels.

85% of patients reported a positive experience with SMBP, indicating that with proper training and support, patients can effectively monitor their blood pressure at home, enhancing their care continuity, especially during challenging times like a pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Community Health Center Patients Interested in Self-Measured Blood Pressure Monitoring (SMBP) - And Can They Do It? Roy, D., Meador, M., Sasu, N., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Implementation of Self-Measured Blood Pressure Monitoring, 2015-2016. Jackson, SL., Ayala, C., Tong, X., et al.[2021]

In a study of 224 patients with hypertension over 12 months, self-monitoring blood pressure (SMBP) led to a significant average decrease in systolic blood pressure by 2.5 mm Hg compared to usual care.

The most notable benefit of SMBP was observed in patients aged 60 years and older, where their uncontrolled blood pressure rates dropped from 90.9% at baseline to 38.2% at month 12, indicating SMBP is particularly effective for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Self-Monitoring Blood Pressure in Primary Care: A Randomized Controlled Trial. Aekplakorn, W., Suriyawongpaisal, P., Tansirisithikul, R., et al.[2018]

Self-measurement of blood pressure (SMBP) significantly improved blood pressure control in patients with hypertension in the short term, with a 7.6% higher control rate at week 8 compared to usual care.

However, the effectiveness of SMBP diminished over time, with only a 4.9% difference in control rates remaining by the end of the study, indicating that ongoing support may be needed for sustained blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of self-measurement of blood pressure in patients with hypertension: the Dioampa study]. Dalfó i Baqué, A., Capillas Peréz, R., Guarch Rocarias, M., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-measurement of blood pressure in clinical trials and therapeutic applications. Denolle, T., Waeber, B., Kjeldsen, S., et al.[2007]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]

References

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

Are Community Health Center Patients Interested in Self-Measured Blood Pressure Monitoring (SMBP) - And Can They Do It? [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical Implementation of Self-Measured Blood Pressure Monitoring, 2015-2016. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Self-monitoring blood pressure in hypertension, patient and provider perspectives: A systematic review and thematic synthesis. [2022]

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

Effectiveness of Self-Monitoring Blood Pressure in Primary Care: A Randomized Controlled Trial. [2018]

5. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness of self-measurement of blood pressure in patients with hypertension: the Dioampa study]. [2023]

6. France pubmed.ncbi.nlm.nih.gov

[Association between blood pressure level and the follow up of the guidelines concerning the use of self blood pressure measurement]. [2009]

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

Self-measurement of blood pressure in clinical trials and therapeutic applications. [2007]

8. Spain pubmed.ncbi.nlm.nih.gov

[Accuracy and precision in blood pressure measurement. Comparative study of home self-measurement with measurement in the clinic and out-patient monitoring]. [2020]