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.
Conditions:
🦠 Hypertension 🦠 Hyperlipidemias
🗓️ Study Start (Actual) 11 March 2024
🗓️ Primary Completion (Estimated) March 2025
✅ Study Completion (Estimated) June 2025
👥 Enrollment (Estimated) 1980
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 35 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 September 2023
  • First Submitted that Met QC Criteria 25 September 2023
  • First Posted 2 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 April 2024
  • Last Update Posted 12 April 2024
  • Last Verified April 2024