RecruitingNot ApplicableNCT07478887

Impact of the Corrie Lipids Digital Health Program on Lipid Optimization

Corrie Lipids Program: Optimizing LDL-Cholesterol by Improving Awareness, Access, and Achievement

Sponsor

Johns Hopkins University

Enrollment

1,000 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Lipids Digital Health Cardiovascular Risk Implementation Science LDL-C

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria6

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

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Interventions

DEVICECorrie Lipids Digital Health Program

The Corrie Lipids Program is a digital health initiative for adults with uncontrolled LDL-C and high ASCVD risk. It includes a smartphone app for LDL-C tracking, medication reminders, and education, along with clinician education and support to improve guideline-directed lipid management.