Rationale and design of the Corrie Lipids Program: Impact of a digital health-enabled implementation initiative to improve lipid management.
Allison W Peng, Caroline F Plott, Sohail Zahid...
https://pubmed.ncbi.nlm.nih.gov/41935556Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07478887
Corrie Lipids Program: Optimizing LDL-Cholesterol by Improving Awareness, Access, and Achievement
Led by Johns Hopkins University · Updated on 2026-03-18
1000
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the Corrie Lipids Program, a digital health initiative designed to improve lipid-lowering treatment in adults with uncontrolled LDL cholesterol and high risk of atherosclerotic cardiovascular disease (ASCVD). The study focuses on addressing gaps in care by combining a patient smartphone app, clinician education, and integration into clinical workflows. Researchers will assess its impact on LDL cholesterol goal achievement, app use, prescribing patterns, and monitoring using the RE-AIM framework across multiple centers. Participants will receive access to the Corrie Lipids Digital Health Program, which includes a smartphone app providing LDL cholesterol tracking, medication reminders, and educational content. Clinicians also receive training and coaching to support guideline-based lipid management. The study will track outcomes at 6 and 12 months, including LDL cholesterol goal attainment, app engagement, therapy prescribing rates, and clinician program use. During the study, adults will be monitored for LDL cholesterol levels and app usage. Researchers will collect data on prescriptions, lab tests, and clinician involvement in the program. Participants must have a smartphone and be able to use the app. The study will last at least 12 months, with assessments at 6 and 12 months to understand the program's effectiveness, adoption, and maintenance over time.
CONDITIONS
Brief Title
Impact of the Corrie Lipids Digital Health Program on Lipid Optimization
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Uncontrolled LDL cholesterol according to AHA/ACC guidelines
- At least one major cardiovascular risk factor, such as high ASCVD risk, known ASCVD, familial hypercholesterolemia, diabetes, or history of statin side effects
- Has a primary care physician and/or cardiologist who can prescribe lipid therapy
- Owns a smartphone and agrees to use the digital health app
- Provided informed consent before starting study activities
You will not qualify if you...
- Motor, cognitive, auditory, or visual impairment limiting technology use
- Does not speak English
- Malignancy except certain skin cancers or specific carcinoma in situ within the last 5 years
- Pregnancy, plans to become pregnant or breastfeed, or egg donation plans
- Likely unable to comply with all study procedures
- Any other significant disorder or condition posing safety risks or interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Implementation
Duration - 12 months
Participants use the Corrie Lipids Digital Health Program app to track LDL cholesterol, receive medication reminders, and access educational materials while clinicians support guideline-directed lipid management.
Participants engage with the app and clinical support throughout the program; follow-up assessments at 6 months and 12 months
Trial Site Locations
Total: 1 location
1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
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Research Team
F
Francoise Marvel, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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