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Behavioral Intervention
Healthy Heart Program for High Blood Pressure and High Cholesterol
N/A
Recruiting
Led By Kevin Volpp, MD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-month period
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to use technology to identify eligible patients in primary care clinics and enroll them in a program aimed at changing patient behavior to improve blood pressure and cholesterol levels over a 6-month period. The
Who is the study for?
This trial is for Penn Medicine patients in West/Southwest Philadelphia and Lancaster with high blood pressure or cholesterol. Eligible participants may have heart disease, a risk score of ≥10%, diabetes, an A1c level ≥6.5, or LDL levels ≥190 within the past five years. They must not be on certain cholesterol medications and have had high systolic blood pressure readings recently.
What is being tested?
The trial tests the Penn Med Healthy Heart Program aimed at changing patient behavior to improve blood pressure and cholesterol over six months using EPIC tools for patient identification and the Way to Health platform for program enrollment.
What are the potential side effects?
Since this intervention focuses on lifestyle modification rather than medication, side effects are minimal but can include discomfort from changes in diet or exercise routines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-month period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-month period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in mean LDL-c
Difference in mean Systolic Blood Pressure (SBP)
Secondary study objectives
Difference in Diastolic Blood Pressure (DBP)
Engagement in the BP intervention
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Penn Med Healthy Heart ProgramExperimental Treatment1 Intervention
The Intervention group will receive the blood pressure monitor and move through the 4 HDPP modules of the intervention.
Group II: Usual CareActive Control1 Intervention
This group will not receive the intervention and will continue with usual care.
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,725,068 Total Patients Enrolled
Kevin Volpp, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania
16 Previous Clinical Trials
385,581 Total Patients Enrolled