Health Trials

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Corrie Lipids Digital Health Program

Treatment groups

1,000 Participants
are divided into 1 treatment group

Locations

1
Johns Hopkins University School of Medicine21287, BaltimoreMaryland, United States

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

Amgen

Collaborator

NewAmsterdam Pharma

Collaborator

Source ClinicalTrials.gov