Impact of the Corrie Lipids Digital Health Program on Lipid Optimization

Johns Hopkins University

Status: Enrolling

Conditions: Lipids; Implementation Science; Digital Health; LDL-C; Cardiovascular Risk

Treatments: Device: Corrie Lipids Digital Health Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07478887

IRB00476278

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

Corrie Lipids Program

Experimental group

Description:

Multicomponent digital health lipid management and education program

Treatment:

Device: Corrie Lipids Digital Health Program