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NCT Number: NCT07478887

Impact of the Corrie Lipids Digital Health Program on Lipid Optimization

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Francoise Marvel, MD

CONTACT

[email protected]

410-502-0469

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of participants achieving guideline-based LDL-C goals

    Time frame: 6 months, 12 months

    LDL-C Goal Achievement assessed 6 months after enrollment in the Corrie Lipids program

  2. Percentage of participants who download and engage with the Corrie app

    Time frame: 6 months

    Patient Engagement With the App defined as downloading and completing an educational article or video among those who were offered the app.

Secondary outcomes

  1. Percentage of patients prescribed statin and non-statin therapies

    Time frame: 12 months

    Lipid-Lowering Therapy Prescribing

  2. Percentage of patients ordered an LDL-C test

    Time frame: 12 months

    LDL-C Test Ordering

  3. Percentage of clinicians utilizing the program for patients

    Time frame: 12 months

    Clinician Uptake of Corrie Lipids Program

  4. Percentage of patients utilizing the app

    Time frame: 12 months

    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)

Other outcomes

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

    Time frame: 12 months

    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

  2. Clinician Knowledge Improvement assessed by survey

    Time frame: Baseline, 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francoise Marvel, MD

CONTACT

[email protected]

410-502-0469

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Amgen
  • NewAmsterdam Pharma

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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