Rationale and design of the Corrie Lipids Program: Impact of a digital health–enabled implementation initiative to improve lipid management

RATIONALE: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of morbidity and mortality worldwide. Lowering low-density lipoprotein cholesterol (LDL-C) with statins and nonstatin therapies has been demonstrated to reduce cardiovascular events. However, real-world evidence consistently reveals large treatment gaps, including underprescribing of lipid-lowering therapy, limited intensification, and poor patient adherence. Observational registries describe these treatment gaps, and randomized trials demonstrate therapy efficacy under controlled conditions, but interventions translating these findings into routine clinical practice remain limited. The Corrie Lipids Program is a digital health initiative designed to address these critical gaps in lipid-lowering as a component of ASCVD treatment by delivering an intervention that combines a patient-facing smartphone app, clinician education and coaching, and seamless incorporation into clinical workflows. PRIMARY HYPOTHESIS: The Corrie Lipids Program will increase the proportion of high-risk patients achieving guideline-directed LDL-C goals at 6 and 12 months, and improve both patient and clinician engagement with lipid management through utilizing a digital health platform. DESIGN: This is a prospective, multicenter, implementation science study. Participants receive a patient-facing smartphone app with features including lipid tracking, medication reminders, educational content, and engagement tools. Clinicians receive virtual coaching, decision support, and workflow integration to optimize guideline-directed therapy. The study uses the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to evaluate effectiveness, adoption, and implementation outcomes. Qualitative interviews with patients and clinicians will explore barriers and facilitators to program adoption. No randomization or control group is included. SITES: This study will initially enroll at 3 academic medical centers: Johns Hopkins Medicine, Inova Schar Heart and Vascular, and Penn State Health, with plans for future expansion to additional sites. ESTIMATED ENROLLMENT: A total of 1,000 adult patients with uncontrolled LDL-C and at high risk for ASCVD, defined as known or subclinical ASCVD diagnosed by imaging, familial hypercholesterolemia or LDL-C ≥190 mg/dL, diabetes mellitus, individuals who meet criteria for lipid-lowering therapy based on ASCVD risk assessment in the most up-to-date guidelines, or statin-intolerance. ENROLLMENT DATES: Initiated in June 2025 with estimated completion of follow-up by early 2027. CURRENT STATUS: Currently enrolling, with 124 patients enrolled as of March 1, 2026. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT07478887.