Heart to Heart for High Blood Pressure

Overseen By Steve Rothschild, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Renal disease, Crohn's disease, others

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

Compensation: Varies

Number of Visits: 15

Duration: 12 months

312 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a 12-month behavioral cluster-randomized trial testing a church-based intervention to reduce blood pressure in African Americans with uncontrolled blood pressure.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Heart to Heart for high blood pressure?

A program that combines education, empowerment, and monitoring, similar to the Heart to Heart treatment, has been shown to improve health outcomes and reduce healthcare costs for managing high blood pressure. ^{1 2 3 4 5}

Is the Heart to Heart treatment safe for humans?

The Heart to Heart program is a computer-based tool designed to help assess and reduce the risk of coronary heart disease, and there is no specific safety data available for it as a treatment. However, it involves evaluating risk factors and suggesting interventions like aspirin or antihypertensive medication, which are generally considered safe when used appropriately. ^{1 6 7 8 9}

How is the Heart to Heart treatment for high blood pressure different from other treatments?

The Heart to Heart treatment is unique because it uses a computer-based decision aid to provide personalized, evidence-based information about heart disease risk and potential interventions, helping patients and providers make informed decisions about managing high blood pressure. ^{1 6 10 11 12}

Eligibility Criteria

This trial is for African American adults with uncontrolled high blood pressure who attend church regularly and can join weekly Zoom meetings. Eligible churches must have a majority of African American members and be able to recruit participants. People unable to make dietary changes or give informed consent, planning to move soon, or with certain medical conditions are excluded.

Inclusion Criteria

Churches: At least 75 members and ability to recruit 15 study participants

I can attend weekly meetings on Zoom.

Participants: Consents and completes all baseline assessments

Exclusion Criteria

I cannot eat vegetables due to a severe medical condition.

Participants: Member of household participating in another church

Participants: Plans to move within the 6 months following enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-month church-based intervention to reduce blood pressure

12 months

Regular church-based sessions

Follow-up

Participants are monitored for changes in blood pressure, medication adherence, and quality of life

3 months

Follow-up assessments at 15 months

Treatment Details

Interventions

• Heart to Heart
• Money Smart

Trial Overview The study tests 'Heart to Heart', a heart health intervention, and 'Money Smart', a financial wellness program in churches over 12 months. It's randomized, meaning participants are put into groups by chance to compare the effects on blood pressure control among African Americans.

Participant Groups

Group I: Heart to Heart Experimental Treatment 1 Intervention

Group II: Money Smart Active Control 1 Intervention

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Findings from Research

Home blood pressure telemonitoring (HBPT) significantly improved blood pressure control, reducing systolic blood pressure by 4.71 mmHg and diastolic blood pressure by 2.45 mmHg compared to usual care, with a higher proportion of patients achieving normalized blood pressure levels.

While HBPT led to increased healthcare costs per patient, it also improved the physical quality of life and did not increase the risk of adverse events, suggesting it is a beneficial but more expensive option for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. Omboni, S., Gazzola, T., Carabelli, G., et al.[2023]

Heart failure disease management (HFDM) programs can improve patient outcomes and reduce hospitalizations, but implementing these programs results in significant financial losses for healthcare providers, with estimated losses of $179,549 for physicians, $464,132 for integrated health systems, and $652,643 for hospitals in the first year.

While third-party payers can save approximately $713,661 annually for managing 350 patients in HFDM programs, the lack of financial incentives for providers limits the adoption of these beneficial programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial implications of a model heart failure disease management program for providers, hospital, healthcare systems, and payer perspectives. Whellan, DJ., Reed, SD., Liao, L., et al.[2019]

The pilot disease management program for congestive heart failure (CHF) implemented by Blue Cross and Blue Shield Federal Employee Program showed a significant financial return, saving $1.08 for every dollar spent from the perspective of the funding organization.

When considering savings for all payers, the program yielded a return of $1.15 for every dollar spent, indicating its potential effectiveness in reducing medical expenditures related to CHF management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What can a pilot congestive heart failure disease management program tell us about likely return on investment?: A case study from a program offered to federal employees. vanVonno, CJ., Ozminkowski, RJ., Smith, MW., et al.[2019]

In a study involving 787 patients with chronic heart failure, an intensified management program (INT-HF-MP) did not lead to lower healthcare costs compared to standard management (SM) over a 12-month period, despite higher initial costs for the INT-HF-MP.

There were no significant differences in health outcomes, such as all-cause mortality and hospital readmission rates, between the INT-HF-MP and SM groups, indicating that the intensified approach did not provide additional benefits in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standard vs. intensified management of heart failure to reduce healthcare costs: results of a multicentre, randomized controlled trial. Scuffham, PA., Ball, J., Horowitz, JD., et al.[2022]

The self-measured blood pressure (SMBP) program implemented in a rural community pharmacy significantly reduced systolic blood pressure by an average of 17 mm Hg and diastolic blood pressure by 12 mm Hg, indicating its effectiveness in managing hypertension among the 20 participants.

Patient confidence in managing their blood pressure increased by 14%, and all participants reported high satisfaction with the program, highlighting its positive impact on both health outcomes and patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a self-measured blood pressure program in a community pharmacy: A pilot study. Jarvis, H., Oprinovich, S., Guthrie, K.[2022]

Heart to Heart is a personalized decision aid that helps patients and healthcare providers understand coronary heart disease (CHD) risk and explore effective interventions based on individual risk factors, using established Framingham risk equations.

The tool allows users to calculate the risk of CHD events over 5 or 10 years and assess the impact of various interventions, such as medication and lifestyle changes, on reducing that risk, paving the way for future research on its effectiveness in improving intervention utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart to Heart: a computerized decision aid for assessment of coronary heart disease risk and the impact of risk-reduction interventions for primary prevention. Pignone, M., Sheridan, SL., Lee, YZ., et al.[2019]

In a study involving 21,104 participants, nearly 19% owned home blood pressure monitors (HBPMs) that lacked clear evidence of validation against standardized protocols, which raises concerns about the accuracy of their blood pressure readings.

Validated HBPMs were more common among participants, with 81.3% owning monitors recognized as validated by reputable organizations, and these validated devices were typically more expensive, indicating a potential link between cost and reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure monitors owned by participants in a large decentralised clinical trial in hypertension: the Treatment In Morning versus Evening (TIME) study. Anbarasan, T., Rogers, A., Rorie, DA., et al.[2023]

A cluster-randomized trial involving 450 patients showed that home blood pressure telemonitoring combined with pharmacist management significantly reduced cardiovascular events over 5 years compared to usual care, with a composite event incidence of 4.4% in the telemonitoring group versus 8.6% in the usual care group.

The telemonitoring intervention not only lowered blood pressure but also resulted in substantial cost savings, with an estimated net savings of about $1900 per patient over 5 years, highlighting its potential as an effective and economical approach to managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension. Margolis, KL., Dehmer, SP., Sperl-Hillen, J., et al.[2021]

The Minnesota Heart Health Program is a comprehensive ten-year initiative aimed at preventing coronary heart disease through community-wide efforts, including systematic hypertension screening and educational programs.

By implementing multiple strategies across different sites and conducting annual surveys, the program aims to gather evidence on the effectiveness of these prevention methods in reducing heart disease risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention and treatment of hypertension at the population level: the Minnesota Heart Health Program]. Murray, D., Luepker, R., Grimm, R., et al.[2017]

The National High Blood Pressure Education Program has successfully improved public knowledge about blood pressure and its related health issues over 15 years through targeted education efforts.

The program utilized various health-education strategies, including media development and community engagement, to effectively translate research findings into practical knowledge for patients and health professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The National High Blood Pressure Education Program: measuring progress and assessing its impact. Roccella, EJ., Horan, MJ.[2004]

The home-based virtual hypertension program significantly reduced blood pressure in participants after 3 months, while the usual care group showed no change, indicating the program's efficacy in managing hypertension.

Participants in the virtual program monitored their blood pressure much more frequently (about 10 times a week) compared to the control group (about 1 time a week), and there were no adverse events reported, highlighting the program's safety and acceptability among patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a home-based virtual hypertension programme-a pilot feasibility study. Gupta, A., Ellis, SD., Burkhardt, C., et al.[2023]

A 2-year follow-up study of a school program for hypertensive patients showed that participants became more informed about hypertension, followed medical recommendations better, and experienced improved quality of life.

The program led to a significant decrease in hypertensive crises and urgent hospitalizations, while a control group showed no improvements, highlighting the effectiveness and cost-effectiveness of the educational intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical and economic effectiveness of the activity of a hypertensive patient school]. Baksheev, VI., Kolomoets, NM.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023]

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

Financial implications of a model heart failure disease management program for providers, hospital, healthcare systems, and payer perspectives. [2019]

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

What can a pilot congestive heart failure disease management program tell us about likely return on investment?: A case study from a program offered to federal employees. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Standard vs. intensified management of heart failure to reduce healthcare costs: results of a multicentre, randomized controlled trial. [2022]

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

Implementation of a self-measured blood pressure program in a community pharmacy: A pilot study. [2022]

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

Heart to Heart: a computerized decision aid for assessment of coronary heart disease risk and the impact of risk-reduction interventions for primary prevention. [2019]

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

Home blood pressure monitors owned by participants in a large decentralised clinical trial in hypertension: the Treatment In Morning versus Evening (TIME) study. [2023]

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

Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension. [2021]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Prevention and treatment of hypertension at the population level: the Minnesota Heart Health Program]. [2017]

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

The National High Blood Pressure Education Program: measuring progress and assessing its impact. [2004]

11. England pubmed.ncbi.nlm.nih.gov

Implementing a home-based virtual hypertension programme-a pilot feasibility study. [2023]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Clinical and economic effectiveness of the activity of a hypertensive patient school]. [2019]