Impact of the Corrie Lipids Digital Health Program on Lipid Optimization

NCT07478887 | Recruiting

• 1 other identifier: IRB00476278
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Apolipoprotein B (apoB); Lipoprotein-a (Lp(a)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Percentage of patients prescribed statin and non-statin therapies

  12 months

• Percentage of patients ordered an LDL-C test

  12 months

• Percentage of clinicians utilizing the program for patients

  12 months

• Percentage of patients utilizing the app

  12 months

Other Outcomes (2)

• Percentage of Patients LDL-C Goal Achievements in App (Users versus Non-Users)

  12 months

• Clinician Knowledge Improvement assessed by survey

  Baseline, 12 months

Study Arms (1)

Corrie Lipids Program

EXPERIMENTAL

Multicomponent digital health lipid management and education program

Device: Corrie Lipids Digital Health Program

Interventions

Corrie Lipids Digital Health Program DEVICE

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.

Corrie Lipids Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Amgen: collaborator
• NewAmsterdam Pharma: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

Study Officials

• Stacey Schott, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francoise Marvel, MD

CONTACT

410-502-0469; fmarvel1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)