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Recruiting NCT07478887

Impact of the Corrie Lipids Digital Health Program on Lipid Optimization

No phase Interventional Cardiovascular Risk LDL-C Lipids Digital Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Corrie Lipids Digital Health Program.
Who it may be relevant to
Registry conditions: Cardiovascular Risk, LDL-C, Lipids, Digital Health. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device 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 measures

  • 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]
Secondary outcome measures (4)
  • Percentage of patients prescribed statin and non-statin therapies [Time frame: 12 months]
  • Percentage of patients ordered an LDL-C test [Time frame: 12 months]
  • Percentage of clinicians utilizing the program for patients [Time frame: 12 months]
  • Percentage of patients utilizing the app [Time frame: 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Johns Hopkins University School of Medicine — Baltimore

Publications

  • Peng AW, Plott CF, Zahid S, Kassamali AA, Jones LK, Campbell-Salome G, Davis E, Head L, Kalich BA, Spitz JA, Farbaniec M, Schott SL, Martin SS, Marvel FA. Rationale and design of the Corrie Lipids Program: Impact of a digital health-enabled implementation initiative to improve lipid management. Am Heart J. 2026 Aug;298:107440. doi: 10.1016/j.ahj.2026.107440. Epub 2026 Apr 2. PMID 41935556

Identifiers

NCT: NCT07478887 · IRB00476278

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗