Recruiting

Healthy Heart

Sponsor:

University of Pennsylvania

Code:

NCT06062394

Conditions

Hypertension

Hyperlipidemias

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Penn Med Healthy Heart Program

Study Details

Brief 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.

Conditions

Hypertension

Hyperlipidemias

Study ID

NCT06062394

Start date

Mar 11, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1980 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Usual Care

This group will not receive the intervention and will continue with usual care.

experimental: Penn Med Healthy Heart Program

The Intervention group will receive the blood pressure monitor and move through the 4 HDPP modules of the intervention.

Interventions

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 outcome measure

  • Difference in mean Systolic Blood Pressure (SBP) [ Time Frame: 6-month period ]
  • Difference in mean LDL-c [ Time Frame: 6-month period ]

Central Contacts and Locations

Central contacts

Kayla Clark, MPH

215-746-4428kayla.clark@pennmedicine.upenn.edu

Laurie Norton, MA, MBE

Laurie.Norton@pennmedicine.upenn.edu

Locations

Penn Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Laurie A Norton, MA, MBE

215-573-8799Laurie.Norton@pennmedicine.upenn.edu

Kayla Clark, MPH

215-746-4428Kayla.Clark@pennmedicine.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-03-12.