Recruiting

Penn Medicine Healthy Heart

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.

ClinicalTrials.gov IDNCT06062394

PhaseNA

Enrollment1980

SponsorUniversity of Pennsylvania

Age35 Years

SexALL

I'm interested View official listing

Conditions studied

Hypertension, Hyperlipidemias

About this study

Interventions

Behavioral: Penn 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.

Primary outcomes

Difference in mean Systolic Blood Pressure (SBP) (6-month period)
Difference in mean LDL-c (6-month period)

Eligibility information

Inclusion Criteria: * On the Penn Medicine Primary Care Service Line registry * Last 2 Blood Pressure readings with Systolic Blood Pressure \>=140 from any outpatient encounter in the last 12 months AND * ASCVD dx OR ASCVD risk score ≥10% OR Diabetes dx OR A1c ≥6.5 in last year OR Diabetes registry OR Last LDL ≥190 in past five years AND * Not on a statinor PCSK9, Inclisiran OR on a Low-intensity/moderate-intensity statin) with LDL \>100 Exclusion Criteria: * Patients on PCSK9 inhibitors * Documented statin allergy/ or intolerance in the EMR * Pregnancy * Breast feeding * Markedly shortened life expectancy including: 1. metastatic cancer 2. hospice 3. End Stage Renal Disease 4. Congestive Heart Failure 5. Dementia * Is a non-English speaker requiring a translator * Patients who do not have a cell phone

Study locations

Penn Medicine, Philadelphia, Pennsylvania 19104 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.