Impact of the Corrie Lipids Digital Health Program on Lipid Optimization

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Risk; Implementation Science; Lipids; Digital Health; LDL-C
• Intervention / Treatment: Device: Corrie Lipids Digital Health Program

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francoise Marvel, MD; Phone Number: 410-502-0469; Email: fmarvel1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University School of Medicine
      • Contact: Francoise Marvel, MD; Phone Number: 410-502-0469; Email: fmarvel1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corrie Lipids Program; Multicomponent digital health lipid management and education program	Device: Corrie 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants achieving guideline-based LDL-C goals	LDL-C Goal Achievement assessed 6 months after enrollment in the Corrie Lipids program	6 months, 12 months
Percentage of participants who download and engage with the Corrie app	Patient Engagement With the App defined as downloading and completing an educational article or video among those who were offered the app.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients prescribed statin and non-statin therapies	Lipid-Lowering Therapy Prescribing	12 months
Percentage of patients ordered an LDL-C test	LDL-C Test Ordering	12 months
Percentage of clinicians utilizing the program for patients	Clinician Uptake of Corrie Lipids Program	12 months
Percentage of patients utilizing the app	Patient Uptake of Corrie Lipids Program. Percentage of patients utilizing the app (including the amount of time spent on the app, the features used, and whether patients continue to utilize the app over time)	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients LDL-C Goal Achievements in App (Users versus Non-Users)	Percentage of patients who engaged with the app and achieved LDL-C goals versus percentage of patients who did not engage with the app who achieved LDL-C goals	12 months
Clinician Knowledge Improvement assessed by survey	Improvement on knowledge assessment from pre- to post- Corrie Lipids Program, measured by percentage of questions correct on knowledge assessment pre-program (baseline, time of enrollment) versus percentage of questions correct on knowledge assessment post-program.	Baseline, 12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Amgen; NewAmsterdam Pharma
• Investigators: Principal Investigator: Stacey Schott, MD, MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Apolipoprotein B (apoB); Lipoprotein-a (Lp(a)
• Other Study ID Numbers: IRB00476278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No