RecruitingNot ApplicableNCT06062394

Penn Medicine Healthy Heart

Reducing Atherosclerotic Cardiovascular Disease (ASCVD) Through a Comprehensive Heart Disease Prevention Program (HDPP)

Sponsor

University of Pennsylvania

Enrollment

1,980 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

Hypertension Hyperlipidemias

Summary

To leverage access to patients across the primary care network, EPIC tools for identifying eligible patients, and the Way to Health platform to launch and enroll a program that will be evaluated in a clinical trial that is focused on changing patient behavior and powered to detect differences in improving blood pressure and cholesterol over 6 months for Penn Medicine patients in West/Southwest Philadelphia and Lancaster.

Eligibility

Min Age: 35 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a heart health program for Penn Medicine primary care patients with high blood pressure and other cardiovascular risk factors who may benefit from better cholesterol management. **You may be eligible if...** - You receive care through Penn Medicine's primary care network - Your last 2 blood pressure readings were 140 mmHg systolic or higher - You have heart disease, diabetes, high cardiovascular risk, or an LDL above 190 - You are not already on a high-intensity statin or PCSK9/Inclisiran, or your LDL is still above 100 **You may NOT be eligible if...** - You are on PCSK9 inhibitors or have a documented statin allergy - You are pregnant or breastfeeding - You have metastatic cancer, hospice care, end-stage renal disease, severe heart failure, or dementia - You do not speak English or do not have a cell phone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPenn Med Healthy Heart Program

Patients randomized to the intervention arm will be assigned a Patient Navigator (Clinical Research Coordinators, with support from Nurse Practitioners and a Medical Director) who will conduct an initial assessment with the patient to determine their main barriers to improving blood pressure and cholesterol control. The Patient Navigators will provide the patient with a home blood pressure cuff for remote monitoring, support from Way to Health text message reminders, referrals to established Penn Medicine smoking cessation programs, and referrals to nutrition and social workers as applicable. The Patient Navigators will help move the patients through four modules: Blood Pressure, Food Insecurity/Nutrition Screening, Statins, and Smoking Cessation. These modules provide patients with the chance to work on blood pressure, cholesterol control, access nutrition resources, and smoking cessation simultaneously or sequentially.