Heart to Heart for High Blood Pressure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rush University Medical Center
Disqualifiers: Renal disease, Crohn's disease, others
No Placebo Group
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.
12345Is 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.
16789How 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.
16101112Eligibility 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 am 18 years old or older.
I can attend weekly meetings on Zoom.
+4 more
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
+5 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Heart to HeartExperimental Treatment1 Intervention
Group II: Money SmartActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rush University Medical CenterChicago, IL
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Who Is Running the Clinical Trial?
Rush University Medical CenterLead Sponsor
References
Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023]To systematically review data from randomized controlled studies on the effectiveness of home blood pressure telemonitoring (HBPT) versus usual care with respect to improvement of BP control, healthcare resources utilization and costs, patient's quality of life and adverse events.
Financial implications of a model heart failure disease management program for providers, hospital, healthcare systems, and payer perspectives. [2019]Although heart failure disease management (HFDM) programs improve patient outcomes, the implementation of these programs has been limited because of financial barriers. We undertook the present study to understand the economic incentives and disincentives for adoption of disease management strategies from the perspectives of a physician (group), a hospital, an integrated health system, and a third-party payer. Using the combined results of a group of randomized controlled trials and a set of financial assumptions from a single academic medical center, a financial model was developed to compute the expected costs before and after the implementation of a HFDM program by 3 provider types (physicians, hospitals, and health systems), as well as the costs incurred from a payer perspective. The base-case model showed that implementation of HFDM results in a net financial loss to all potential providers of HFDM. Implementation of HFDM as described in our base-case analysis would create a net loss of US dollars 179,549 in the first year for a physician practice, US dollars 464,132 for an integrated health system, and US dollars 652,643 in the first year for a hospital. Third-party payers would be able to save US dollars 713,661 annually for the care of 350 patients with heart failure in a HFDM program. In conclusion, although HFDM programs may provide patients with improved clinical outcomes and decreased hospitalizations that save third-party payers money, limited financial incentives are currently in place for healthcare providers and hospitals to initiate these programs.
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]In 1999, the Blue Cross and Blue Shield Federal Employee Program (FEP) implemented a pilot disease management program to manage congestive heart failure (CHF) among members. The purpose of this project was to estimate the financial return on investment in the pilot CHF program, prior to a full program rollout. A cohort of 457 participants from the state of Maryland was matched to a cohort of 803 nonparticipants from a neighboring state where the CHF program was not offered. Each cohort was followed for 12 months before the program began and 12 months afterward. The outcome measures of primary interest were the differences over time in medical care expenditures paid by FEP and by all payers. Independent variables included indicators of program participation, type of heart disease, comorbidity measures, and demographics. From the perspective of the funding organization (FEP), the estimated return on investment for the pilot CHF disease management program was a savings of $1.08 in medical expenditure for every dollar spent on the program. Adding savings to other payers as well, the return on investment was a savings of $1.15 in medical expenditures per dollar spent on the program. The amount of savings depended upon CHF risk levels. The value of a pilot initiative and evaluation is that lessons for larger-scale efforts can be learned prior to full-scale rollout.
Standard vs. intensified management of heart failure to reduce healthcare costs: results of a multicentre, randomized controlled trial. [2022]To determine if an intensified form of heart failure management programme (INT-HF-MP) based on individual profiling is superior to standard management (SM) in reducing health care costs during 12-month follow-up (primary endpoint).
Implementation of a self-measured blood pressure program in a community pharmacy: A pilot study. [2022]Hypertension is a leading cause of cardiovascular disease in the United States and is costing the health care system billions of dollars annually. A health program that combines education, empowerment, and monitoring has shown to improve clinical outcomes and decrease overall health care costs.
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]Heart to Heart is a computer-based decision aid for patients and providers that provides personalized, evidence-based information about coronary heart disease (CHD) risk and potential risk-reducing interventions. To develop Heart to Heart, the authors used Framing-ham risk equations and systematic reviews of risk-reducing interventions. The Web version was programmed using PHP: Hypertext Processor, a Web-based programming language, and has separate interfaces for providers and patients. The authors subsequently developed a modified version for personal digital assistants. Heart to Heart uses information about a patient's CHD risk factors (age, gender, total and high-density lipoprotein cholesterol levels, diabetes, smoking, systolic blood pressure, and left ventricular hypertrophy) to calculate risk of total CHD events over 5 or 10 years. Patients and providers can then examine the effect of introducing one or more risk-reducing interventions (aspirin, lipid-lowering drug therapy, antihypertensive medication, or smoking cessation) on the patient's CHD risk. Future research will be directed to determining whether Heart to Heart can improve utilization of effective CHD risk-reducing interventions.
Home blood pressure monitors owned by participants in a large decentralised clinical trial in hypertension: the Treatment In Morning versus Evening (TIME) study. [2023]Various home blood pressure monitors (HBPMs) are available to the public for purchase but only some are validated against standardised protocols. This study aimed to assess whether HBPMs owned by participants taking part in a clinical trial were validated models. The TIME study is a decentralised randomised trial investigating the effect of antihypertensive medication dosing time on cardiovascular outcomes in adults with hypertension. No HBPMs were provided to participants in this trial but patients were asked to report if they already owned one. We identified the model of HBPM reported by participants, then cross-referenced this against lists of validated HBPMs produced by dabl Educational Trust and the British and Irish Hypertension Society (BIHS). Of 21,104 participants, 10,464 (49.6%) reported their model of HBPM. 7464 (71.3%) of these participants owned a monitor that could be identified from the participants' entry. Of these, 6066 (81.3%) participants owned a monitor listed as validated by either dabl (n = 5903) or BIHS (n = 5491). Some were listed as validated by both. 1398 (18.7%) participants owned an identifiable HBPM that lacked clear evidence of validation. 6963 (93.3%) participants owned an upper arm HBPM and 501 (6.7%) owned a wrist HBPM. Validated HBPMs had a higher median online retail price of £45.00 compared to £20.00 for HBPMs lacking clear evidence of validation. A significant number of participants own HBPMs lacking evidence of validation.
Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension. [2021]Uncontrolled hypertension is a leading contributor to cardiovascular disease. A cluster-randomized trial in 16 primary care clinics showed that 12 months of home blood pressure telemonitoring and pharmacist management lowered blood pressure more than usual care (UC) for 24 months. We report cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, hospitalized heart failure, coronary revascularization, and cardiovascular death) and costs over 5 years of follow-up. In the telemonitoring intervention (TI group, n=228), there were 15 cardiovascular events (5 myocardial infarction, 4 stroke, 5 heart failure, 1 cardiovascular death) among 10 patients. In UC group (n=222), there were 26 events (11 myocardial infarction, 12 stroke, 3 heart failure) among 19 patients. The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21-1.13], P=0.09). Including 2 coronary revascularizations in the TI group and 10 in the UC group, the secondary cardiovascular composite end point incidence was 5.3% in the TI group versus 10.4% in the UC group (odds ratio, 0.48 [95% CI, 0.22-1.08], P=0.08). Microsimulation modeling showed the difference in events far exceeded predictions based on observed blood pressure. Intervention costs (in 2017 US dollars) were $1511 per patient. Over 5 years, estimated event costs were $758 000 in the TI group and $1 538 000 in the UC group for a return on investment of 126% and a net cost savings of about $1900 per patient. Telemonitoring with pharmacist management lowered blood pressure and may have reduced costs by avoiding cardiovascular events over 5 years. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781365.
[Prevention and treatment of hypertension at the population level: the Minnesota Heart Health Program]. [2017]The Minnesota Heart Health Program is a ten year research and demonstration trial for the primary prevention of coronary heart disease. Community wide prevention and control of hypertension is among the major goals of this study. Systematic population screening for hypertension, mass media campaigns, adult and youth education programs, physician and health professional programs, and community organization efforts are part of the multiple strategy approach to prevention. Replication in three sites, annual risk factor surveys and morbidity/mortality surveillance will provide evidence for the value of this community wide approach at the end of ten years.
The National High Blood Pressure Education Program: measuring progress and assessing its impact. [2004]The National High Blood Pressure Education Program has been designed to translate the results of basic and clinical research to medical practice through a program of education for the public, patients, and health professionals. It has continuously used health-education principals of media development, patient education, social networking, community organizations, theories of social change, and program evaluation and measurement to reach its objectives. After 15 years, public knowledge regarding blood pressure and its sequelae has improved dramatically.
Implementing a home-based virtual hypertension programme-a pilot feasibility study. [2023]Implementing a health system-based hypertension programme may lower blood pressure (BP).
[Clinical and economic effectiveness of the activity of a hypertensive patient school]. [2019]The authors propose an original program of learning in the school of a hypertensive patient (SHP) which includes 12 sixty-minute lessons devoted to causes of the disease, cardiovascular complications, methods of their prevention at treatment, and rehabilitation. The analysis of the results of 2-year follow-up showed that most of the learners became informed about the risks of hypertension, better followed recommendations of their doctor, improved their life quality. The number of hypertensive crises and urgent hospitalizations decreased significantly. In the control group of 112 patients no improvement was seen in the level of blood pressure, quality of life and prognosis. Moreover, learning in the SHP proved highly cost-effective.