Program to improve heart health in patients with high blood pressure and cholesterol
Reducing Atherosclerotic Cardiovascular Disease (ASCVD) Through a Comprehensive Heart Disease Prevention Program (HDPP)
This study is testing a six-month program to help people with high blood pressure and cholesterol improve their heart health using new support tools and strategies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1980 (estimated) |
| Ages | 35 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06062394 on ClinicalTrials.gov |
What this trial studies
This program aims to enroll patients from the Penn Medicine primary care network to participate in a six-month initiative focused on reducing hypertension and hyperlipidemia. Utilizing behavioral economics insights, the program encourages adherence to evidence-based interventions while relieving the burden on primary care providers through automated technology and a centralized support team. The effectiveness of the program will be evaluated by measuring changes in blood pressure and cholesterol levels over the six-month period for patients in West/Southwest Philadelphia and Lancaster, PA.
Who should consider this trial
Good fit: Ideal candidates include patients registered with Penn Medicine who have elevated blood pressure and cholesterol levels and meet specific cardiovascular risk criteria.
Not a fit: Patients with certain exclusions such as those on specific cholesterol medications, those with severe health conditions, or non-English speakers may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve heart health outcomes for patients with hypertension and high cholesterol.
How similar studies have performed: Other studies utilizing behavioral economics in health interventions have shown promising results, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- Penn Medicine — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kevin Volpp, MD, PhD — University of Pennsylvania
- Study coordinator: Kayla Clark, MPH
- Email: kayla.clark@pennmedicine.upenn.edu
- Phone: 215-746-4428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.