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Impact of the Corrie Lipids Digital Health Program on Lipid Optimization
Corrie Lipids Program: Optimizing LDL-Cholesterol by Improving Awareness, Access, and Achievement
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Age ≥18 years * Uncontrolled LDL-C per AHA/ACC guidelines * At least 1 major cardiovascular risk factor, including: high risk for ASCVD (individuals who meet criteria for Lipid-Lowering Therapy (LLT) based on ASCVD risk assessment using the most up-to-date guidelines), known ASCVD or subclinical ASCVD based on imaging, clinically diagnosed familial hypercholesterolemia or LDL-C ≥190 mg/dL, diabetes mellitus, history of statin-associated side effects * Has a primary care physician and/or cardiologist who can prescribe lipid therapy * Owns a smartphone and agrees to the End User License Agreement to use the digital health app * Provided informed consent before initiation of study-specific activities Exclusion Criteria: * Motor, cognitive, auditory, or visual impairment limiting technology use * Does not speak English * Malignancy (except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ within the previous 5 years) * Pregnancy (positive pregnancy test, highly sensitive urine or serum), plan to become pregnant or donate eggs, breastfeeding or plan to breastfeed * Likely to not be available to comply with all required study procedures to the best of the patient's and investigator's knowledge * History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion
About the study
The overall objective is to evaluate the effectiveness and implementation of the Corrie Lipids Program, a comprehensive digital health initiative designed to address 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.
Researchers plan to assess this multicenter digital health initiative in approximately 1,000 adults with uncontrolled LDL-C and elevated ASCVD risk using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study will examine whether the program improves LDL-C goal attainment, app engagement, prescribing patterns, and LDL-C monitoring, while also identifying barriers and facilitators to implementation across sites.
What is being tested
- Corrie Lipids Digital Health Program (device)
Sponsor: Johns Hopkins University · Participants: 1,000 · Started: Jun 20, 2025
Contact the study team
- Francoise Marvel, MD · Phone: 410-502-0469
Official record on ClinicalTrials.gov — NCT07478887
Locations in the U.S.
| Maryland | Johns Hopkins University School of Medicine, Baltimore |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.