Penn Medicine Healthy Heart

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06062394
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Penn Med Healthy Heart Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 11, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,980 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn MedicinePhiladelphiaPennsylvania19104
Laurie A Norton, MA, MBE
[email protected]
215-573-8799
Kayla Clark, MPH
[email protected]
215-746-4428

Find similar trials in Philadelphia, PA

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Penn Medicine· Philadelphia, PA

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