Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT06062394
Status:
RECRUITING
Last Update Posted:
2025-04-20
First Post:
2023-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Penn Medicine Healthy Heart
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1980}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2023-09-25', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in mean Systolic Blood Pressure (SBP)', 'timeFrame': '6-month period', 'description': 'Whether mean SBP is improved among those assigned to intervention vs those assigned to control'}, {'measure': 'Difference in mean LDL-c', 'timeFrame': '6-month period', 'description': 'Whether mean LDL-c is improved among those assigned to intervention vs those assigned to control'}], 'secondaryOutcomes': [{'measure': 'Engagement in the BP intervention', 'timeFrame': '6-month period', 'description': 'Engagement in the BP intervention as measured by number of participants who agree to receive blood pressure monitor'}, {'measure': 'Difference in Diastolic Blood Pressure (DBP)', 'timeFrame': '6-month period', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Hyperlipidemias']}, 'referencesModule': {'references': [{'pmid': '39341482', 'type': 'DERIVED', 'citation': 'Volpp KG, Mahraj K, Norton LA, Asch DA, Glanz K, Mehta SJ, Balasta M, Kellum W, Wood J, Russell LB, Fanaroff AC, Bakshi S, Jacoby D, Cohen JB, Press MJ, Clark K, Zhu J, Rareside C, Ashcraft LE, Snider C, Putt ME. Design and rationale of penn medicine healthy heart, a randomized trial of effectiveness of a centrally organized approach to blood pressure and cholesterol improvement among patients at elevated risk of atherosclerotic cardiovascular disease. Am Heart J. 2024 Dec;278:208-222. doi: 10.1016/j.ahj.2024.09.029. Epub 2024 Sep 27.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On the Penn Medicine Primary Care Service Line registry\n* Last 2 Blood Pressure readings with Systolic Blood Pressure \\>=140 from any outpatient encounter in the last 12 months AND\n* 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\n* Not on a statinor PCSK9, Inclisiran OR on a Low-intensity/moderate-intensity statin) with LDL \\>100\n\nExclusion Criteria:\n\n* Patients on PCSK9 inhibitors\n* Documented statin allergy/ or intolerance in the EMR\n* Pregnancy\n* Breast feeding\n* Markedly shortened life expectancy including:\n\n 1. metastatic cancer\n 2. hospice\n 3. End Stage Renal Disease\n 4. Congestive Heart Failure\n 5. Dementia\n* Is a non-English speaker requiring a translator\n* Patients who do not have a cell phone'}, 'identificationModule': {'nctId': 'NCT06062394', 'briefTitle': 'Penn Medicine Healthy Heart', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Reducing Atherosclerotic Cardiovascular Disease (ASCVD) Through a Comprehensive Heart Disease Prevention Program (HDPP)', 'orgStudyIdInfo': {'id': '851832'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'This group will not receive the intervention and will continue with usual care.'}, {'type': 'EXPERIMENTAL', 'label': 'Penn Med Healthy Heart Program', 'description': 'The Intervention group will receive the blood pressure monitor and move through the 4 HDPP modules of the intervention.', 'interventionNames': ['Behavioral: Penn Med Healthy Heart Program']}], 'interventions': [{'name': 'Penn Med Healthy Heart Program', 'type': 'BEHAVIORAL', 'otherNames': ['PMHH', 'HDPP'], 'description': '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.', 'armGroupLabels': ['Penn Med Healthy Heart Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laurie A Norton, MA, MBE', 'role': 'CONTACT', 'email': 'Laurie.Norton@pennmedicine.upenn.edu', 'phone': '215-573-8799'}, {'name': 'Kayla Clark, MPH', 'role': 'CONTACT', 'email': 'Kayla.Clark@pennmedicine.upenn.edu', 'phone': '215-746-4428'}], 'facility': 'Penn Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Kayla Clark, MPH', 'role': 'CONTACT', 'email': 'kayla.clark@pennmedicine.upenn.edu', 'phone': '215-746-4428'}, {'name': 'Laurie Norton, MA, MBE', 'role': 'CONTACT', 'email': 'Laurie.Norton@pennmedicine.upenn.edu'}], 'overallOfficials': [{'name': 'Kevin Volpp, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}