Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07478887

Impact of the Corrie Lipids Digital Health Program on Lipid Optimization

Led by Johns Hopkins University · Updated on 2026-03-18

1000

Participants Needed

1

Research Sites

127 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

A

Amgen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Impact of the Corrie Lipids Digital Health Program on Lipid Optimization

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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, including high ASCVD risk, known or subclinical ASCVD, familial hypercholesterolemia or LDL-C ≥190 mg/dL, diabetes mellitus, or history of statin side effects
  • Has a primary care physician and/or cardiologist able to prescribe lipid therapy
  • Owns a smartphone and agrees to use the digital health app
  • Provided informed consent before starting study activities
Not Eligible

You will not qualify if you...

  • Motor, cognitive, auditory, or visual impairments limiting technology use
  • Does not speak English
  • Malignancy except nonmelanoma skin cancers or certain breast/cervical cancers within 5 years
  • Pregnancy, planning pregnancy, egg donation, breastfeeding, or planning to breastfeed
  • Unlikely to comply with study procedures
  • Any other clinically significant condition that may pose safety risks or interfere with study evaluation or completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

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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