Health Education + Home Monitoring for High Blood Pressure

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnant, others

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

Compensation: Varies

Number of Visits: 7

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to manage high blood pressure for Somali community members in the Greater Mankato Area. It focuses on providing health education and home blood pressure monitoring tools to help reduce health care disparities. Participants will either receive education and monitoring tools or a referral to a doctor. Somali community members who visit local mosques or Halal stores between May 2022 and May 2023 might be a good fit. As an unphased trial, this study offers participants the opportunity to contribute to community-specific health solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for managing high blood pressure?

Previous studies have shown that learning about health safely and effectively manages high blood pressure. It helps people understand their condition and make better lifestyle choices, with no reports of harm from this approach.

Research shows that using a home blood pressure monitor is also safe for checking blood pressure levels at home. It allows people to track their blood pressure outside a doctor's office, aiding in better management of their condition. No evidence suggests any problems from using these monitors.

Overall, both health education and home blood pressure monitoring are safe and well-tolerated methods for managing high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Health Education + Home Monitoring approach for high blood pressure because it empowers patients with knowledge and tools to manage their health actively. Unlike standard treatments that primarily rely on medication, this approach combines health education with home blood pressure monitoring, allowing individuals to track their condition in real-time. By also providing referrals to primary care providers, this method aims to improve patient engagement and potentially enhance long-term health outcomes, offering a more holistic and proactive way to manage high blood pressure.

What evidence suggests that health education and home blood pressure monitoring could be effective for managing high blood pressure?

Research shows that learning about health can help manage high blood pressure. Studies have found that educational programs increase patient knowledge and self-care, leading to better blood pressure control. Early findings also suggest that home blood pressure monitoring can help lower blood pressure and improve management. This method has been linked to reduced risks of heart attacks and strokes. In this trial, participants in the treatment group will receive both health education and a home blood pressure monitor, which might effectively manage high blood pressure. ^{6 7 8 9 10}

Who Is on the Research Team?

Erin Westfall, DO

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for non-pregnant members of the Greater Mankato Somali community who frequent mosques or Halal stores. It aims to help those within this group manage high blood pressure better.

Inclusion Criteria

Non-pregnant

It seems that this criterion is incomplete. Can you provide more context or the full criterion so I can accurately summarize it for you?

This criterion states that individuals who have visited the mosque or Halal stores between 5/2/2022 and 5/31/2023 are excluded from the study.

Exclusion Criteria

Pregnant

This criterion is unclear. Could you please provide more context or specify what the criterion is for?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline data collection including blood pressure and PCP status

1 week

1 visit (in-person)

Treatment

Participants receive health education and blood pressure monitoring; control group receives PCP referrals

3 months

3 visits (in-person) at baseline, 3 weeks, and 3 months

Follow-up

Participants are monitored for changes in blood pressure and PCP follow-up status

3 months

2 visits (in-person) at 3 weeks and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Health Education
• Home Blood Pressure Monitor

Trial Overview

The study is testing whether health education and using home blood pressure monitors can reduce hypertension in the targeted population. Participants will receive these interventions and their impact on managing high blood pressure will be observed.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 2 Interventions

Participants will be given access to health education, home blood pressure monitor, and referral to a primary care provider.

Group II: Control Group Active Control 1 Intervention

Participants receive referrals only to a primary care provider (PCP) for blood pressure monitoring.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

In a study involving 287 participants with uncontrolled hypertension, those who received group education on home blood pressure monitoring (HBPM) retained significantly better knowledge compared to those who received individual counseling, with group participants being eight times more likely to achieve full knowledge scores.

Regular practice of HBPM was observed in 67.8% of participants, with factors such as being over 65 years old, not working, and having adequate health literacy positively influencing the likelihood of continued monitoring after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge and practice of home blood pressure monitoring 6 months after the risk and assessment management programme: does health literacy matter? Fu, SN., Dao, MC., Wong, CKH., et al.[2022]

A study involving 109 hypertensive patients showed that both a Family Practice BP tracking diary with an educational booklet and a standard hypertension leaflet significantly improved patients' knowledge about hypertension, with an increase in correct responses to knowledge questions.

Despite the positive reception of the BP tracking tools, the standard leaflet was equally effective in enhancing knowledge, indicating that while patients had a good baseline understanding, there are still critical areas of hypertension management that need further education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a patient education booklet and BP 'tracker' on knowledge about hypertension. A randomized controlled trial. Dawes, MG., Kaczorowski, J., Swanson, G., et al.[2015]

An interactive booklet was created to help patients understand the benefits and risks of antihypertensive drugs, aiming to prevent adverse drug events, which affect 25% of patients and can have severe consequences in 13% of cases.

The development process involved input from 27 experts and feedback from patients and healthcare providers, ensuring the booklet is user-friendly and addresses patient concerns about the expected benefits of antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Information and active patient participation using an interactive booklet in the prescription of antihypertensive drugs in primary care]. Keriel-Gascou, M., Badet-Phan, A., Le Pogam, MA., et al.[2014]

In a pilot study involving 19 hypertensive patients over six months, the Health data Monitoring System (HMS) led to an increase in patients reaching their blood pressure goals from 16% to 37%.

The mean home systolic blood pressure decreased significantly from 138.1 mmHg to 130.2 mmHg, suggesting that regular monitoring with HMS can effectively support hypertension management, especially in men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective pilot trial of the health data monitoring system without educational content for patients with hypertension. Kishi, T., Usui, H., Nagayoshi, S.[2023]

A new data visualization display for home blood pressure measurements was developed to enhance shared decision-making between hypertensive patients and healthcare providers, based on feedback from 40 participants in focus groups.

The display features user-friendly elements like a line graph, color-coded goal ranges, and a medication timeline, which can help patients and providers better understand blood pressure trends and improve treatment decisions for the 35 million Americans with uncontrolled hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure data visualization for the management of hypertension: using human factors and design principles. Wegier, P., Belden, JL., Canfield, SM., et al.[2023]

The educational interventions significantly improved blood pressure control in ambulatory patients, with the proportion of patients achieving controlled blood pressure increasing from 38% to 66%.

In contrast, the control group receiving standard medical therapy without educational support showed no change in blood pressure control, remaining at 42%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health education for hypertensive patients. Levine, DM., Green, LW., Deeds, SG., et al.[2016]

In a study of 39 elderly stroke patients, 90% of their home blood pressure recordings matched the readings from a BP monitor, indicating high reliability in self-monitoring.

The small discrepancies found in the home recordings (average differences of 0.6 mmHg systolic and 0.3 mmHg diastolic) are unlikely to impact clinical management, suggesting that home BP monitoring could be a valuable tool for guiding treatment decisions in hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are stroke patients' reports of home blood pressure readings reliable? Cross-sectional study. Shaw, J., Kerry, S., Adjei-Gyamfi, Y., et al.[2016]

An educational program for hypertensive patients after a stroke significantly improved their knowledge about their condition, with correct response rates increasing from 77.9% to 94.1% after the intervention.

The program also led to better medication adherence and more frequent self-measurement of blood pressure, indicating that education can play a crucial role in managing health post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a hypertension-based patient education program in a stroke center. Ben Nasr, N., Rouault, A., Cornillet, N., et al.[2021]

In a study of 213 adults with hypertension over 3 months, home blood pressure monitoring (HBPM) combined with a health education session did not significantly reduce blood pressure or improve medication adherence compared to usual care.

While the HBPM group showed some reduction in blood pressure, it was not greater than the control group, suggesting that more effective educational interventions and sharing blood pressure data might enhance outcomes in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Home Blood Pressure on 24-Hour Blood Pressure Control: A Randomized Controlled Trial. Cuffee, YL., Sciamanna, C., Gerin, W., et al.[2022]

Patient education is crucial in managing high blood pressure, requiring healthcare providers to assess individual patient needs and create tailored care plans.

Effective educational strategies can improve patient engagement and adherence to treatment, leading to better blood pressure control and overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for patient education. Hill, MN.[2019]

A five-year study involving 400 urban poor hypertensive patients showed that health education interventions significantly improved compliance with treatment and blood pressure control, leading to better health outcomes.

The experimental group experienced a 57.3% reduction in all-cause mortality and a 53.2% reduction in hypertension-related mortality compared to the control group, highlighting the long-term benefits of these educational programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year blood pressure control and mortality following health education for hypertensive patients. Morisky, DE., Levine, DM., Green, LW., et al.[2019]

Home blood pressure monitoring is an effective and cost-efficient method for tracking blood pressure in hypertensive patients, providing better predictions of cardiovascular risk compared to traditional office measurements.

This technique not only enhances patient compliance and blood pressure control but also helps identify conditions like white coat hypertension and masked hypertension, making it a valuable tool in hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure monitoring in clinical practice: a review. Mallick, S., Kanthety, R., Rahman, M.[2009]

A study involving 1,000 elderly individuals in Denmark found that while general knowledge about blood pressure and hypertension was reasonable, many still lacked critical awareness, such as the fact that hypertension can occur without symptoms.

Interestingly, individuals with self-reported hypertension showed greater awareness of blood pressure issues, but overall knowledge about hypertension was not significantly better among them, indicating a need for improved education on the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported knowledge and awareness about blood pressure and hypertension: a cross-sectional study of a random sample of men and women aged 60-74 years. Qvist, I., Thomsen, MD., Lindholt, JS., et al.[2021]

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High blood pressure (BP) is the leading preventable risk factor for global mortality, causing over 10 million deaths annually. Low- and middle- ...