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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to develop ways to reduce hypertension-management-related disparities in the Greater Mankato Area Somali population.

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 data supports the effectiveness of the treatment Health Education + Home Monitoring for High Blood Pressure?

Research shows that health education can significantly improve blood pressure control, medication adherence, and patient knowledge. In one study, patients receiving educational interventions had a 28% increase in controlled blood pressure compared to those who did not receive such education. Additionally, home monitoring of blood pressure can enhance self-management and adherence to treatment plans. ^{1 2 3 4 5}

Is home blood pressure monitoring safe for humans?

Home blood pressure monitoring is generally safe for humans, as it is widely used to track blood pressure and manage hypertension (high blood pressure). The studies focus on improving patient knowledge and involvement, which can help prevent adverse events related to blood pressure management. ^{4 6 7 8 9}

How is the Health Education + Home Monitoring treatment for high blood pressure different from other treatments?

This treatment is unique because it combines health education with home blood pressure monitoring, which helps patients better understand and manage their condition. It emphasizes patient involvement and education, potentially improving medication adherence and blood pressure control compared to traditional office-based monitoring. ^{9 10 11 12 13}

Research Team

Erin Westfall, DO

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Pregnant

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

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

Health education for hypertensive patients. [2016]

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

Strategies for patient education. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a hypertension-based patient education program in a stroke center. [2021]

4. New Zealand 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. [2021]

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

Five-year blood pressure control and mortality following health education for hypertensive patients. [2019]

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

[Information and active patient participation using an interactive booklet in the prescription of antihypertensive drugs in primary care]. [2014]

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

Home blood pressure data visualization for the management of hypertension: using human factors and design principles. [2023]

8. England pubmed.ncbi.nlm.nih.gov

A prospective pilot trial of the health data monitoring system without educational content for patients with hypertension. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The effect of a patient education booklet and BP 'tracker' on knowledge about hypertension. A randomized controlled trial. [2015]

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

The Effectiveness of Home Blood Pressure on 24-Hour Blood Pressure Control: A Randomized Controlled Trial. [2022]

11. England 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? [2022]

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

Home blood pressure monitoring in clinical practice: a review. [2009]

13. England pubmed.ncbi.nlm.nih.gov

Are stroke patients' reports of home blood pressure readings reliable? Cross-sectional study. [2016]