Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Location contact
Kayla Clark, MPH
CONTACT
Laurie A Norton, MA, MBE
CONTACT
NCT Number: NCT06062394
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.
Interested in participating?
Request Info35 year–80 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Kayla Clark, MPH
CONTACT
Laurie A Norton, MA, MBE
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: PMHH, HDPP
Time frame: 6-month period
Whether mean SBP is improved among those assigned to intervention vs those assigned to control
Time frame: 6-month period
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 as measured by number of participants who agree to receive blood pressure monitor
Time frame: 6-month period
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
Contact information is provided by the study sponsor or research team.
Kayla Clark, MPH
CONTACT
Laurie Norton, MA, MBE
CONTACT
University of Pennsylvania
Other
Reducing Atherosclerotic Cardiovascular Disease (ASCVD) Through a Comprehensive Heart Disease Prevention Program (HDPP)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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