Recruiting

Corrie Lipids Program

Sponsor:

Johns Hopkins University

Code:

NCT07478887

Conditions

Cardiovascular Risk

LDL-C

Lipids

Digital Health

Implementation Science

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Corrie Lipids Digital Health Program

Study Details

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

Study ID

NCT07478887

Start date

Jun 20, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Corrie Lipids Program

Multicomponent digital health lipid management and education program

Interventions

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.

Primary outcome measure

  • Percentage of participants achieving guideline-based LDL-C goals [ Time Frame: 6 months, 12 months ]
  • Percentage of participants who download and engage with the Corrie app [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Francoise Marvel, MD

410-502-0469fmarvel1@jhmi.edu

Locations

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Francoise Marvel, MD

410-502-0469fmarvel1@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-18.