An interventional study of Penn Med Healthy Heart Program in Hypertension and Hyperlipidemias, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research
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.
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 Penn Medicine primary care patients into the Penn Medicine Healthy Heart, a six-month program for reduction of hypertension and hypercholesterolemia grounded in behavioral economics insights to increase uptake of and adherence to evidence-based interventions to reduce ASCVD risk. Penn Medicine Healthy Heart emphasizes proactive outreach and prevention outside of a traditional visit model using data assets to identify and risk stratify patients. The program aims to relieve overburdened PCPs through automated hovering technology coupled with a centralized, leveraged team of non-clinical navigators and nurse practitioners. The clinical trial will assess Penn Medicine Healthy Heart and will be powered to detect differences in improving blood pressure and cholesterol over 6 months for Penn Medicine patients in West/Southwest/Downtown Philadelphia and Lancaster, PA.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 1,980 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Markedly shortened including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will not receive the intervention and will continue with usual care.
The Intervention group will receive the blood pressure monitor and move through the 4 HDPP modules of the intervention.
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.
Also known as: PMHH, HDPP
Difference in mean Systolic Blood Pressure (SBP)
Whether mean SBP is improved among those assigned to intervention vs those assigned to control
Time frame: 6-month period
Difference in mean LDL-c
Whether mean LDL-c is improved among those assigned to intervention vs those assigned to control
Time frame: 6-month period
Engagement in the BP intervention
Engagement in the BP intervention as measured by number of participants who agree to receive blood pressure monitor
Time frame: 6-month period
Difference in Diastolic Blood Pressure (DBP)
Whether mean DBP is improved among those assigned to intervention vs those assigned to control Whether mean SBP is improved among those assigned to intervention vs those assigned to control
Time frame: 6-month period
Started Mar 2024 (actual). Primary completion is estimated for Dec 2026, 33 months after the start.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 33 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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