Corrie Lipids program to help lower high LDL cholesterol
Corrie Lipids Program: Optimizing LDL-Cholesterol by Improving Awareness, Access, and Achievement
This program tests whether a smartphone app combined with clinician education and coaching can help adults with uncontrolled LDL-C and high cardiovascular risk reach their cholesterol goals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07478887 on ClinicalTrials.gov |
What this trial studies
The study will implement the Corrie Lipids digital health program across multiple clinical sites and follow about 1,000 adults with uncontrolled LDL-C and elevated ASCVD risk. The intervention pairs a patient-facing smartphone app with clinician education, coaching, and integration into clinical workflows. Investigators will measure LDL-C goal attainment, app engagement, prescribing patterns, and LDL-C monitoring using the RE-AIM implementation framework. The study will also identify barriers and facilitators to adoption at participating sites.
Who should consider this trial
Good fit: Adults aged 18 or older with uncontrolled LDL-C per AHA/ACC guidelines, elevated ASCVD risk or related conditions, access to a smartphone, and a prescribing primary care clinician or cardiologist are ideal candidates.
Not a fit: Patients without a smartphone, who do not speak English, or who have motor, cognitive, auditory, or visual impairments that prevent technology use (as well as pregnant individuals or those with excluded active malignancies) are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could help more high-risk patients reach LDL-C targets faster by combining app-driven support with clinician workflow changes.
How similar studies have performed: Smaller digital health and clinician-coaching programs have shown promise for improving adherence and lipid outcomes, but large multicenter implementation data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Stacey Schott, MD, MPH — Johns Hopkins University
- Study coordinator: Francoise Marvel, MD
- Email: fmarvel1@jhmi.edu
- Phone: 410-502-0469
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.