Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death worldwide and is responsible for over 20 million deaths annually. Despite improvements in ASCVD prevention and treatment, the lifetime risk of developing ASCVD remains high across all demographic groups. ^,,, These realities underscore the urgency of optimizing primary and secondary prevention strategies, particularly those targeting modifiable risk factors such as dyslipidemia. Low-density lipoprotein cholesterol (LDL-C) is a key causal driver of atherosclerosis and ASCVD events, with landmark trials demonstrating that lowering LDL-C through lifestyle modifications and pharmacotherapy can drastically reduce the incidence of myocardial infarction, ischemic stroke, and cardiovascular death. ^,,,,,, The benefit is consistent across age groups, sexes, and baseline risk categories, suggesting that LDL-C lowering is a universal cornerstone of ASCVD prevention.

Reflecting this evidence, major society guidelines through the years have recommended increasingly intensive LDL-C lowering for patients with a high risk for ASCVD. ^,,,, Current American College of Cardiology/American Heart Association guidelines recommend LDL-C reduction to <70 mg/dL or even <55 mg/dL for patients at high or very high risk of ASCVD, often requiring the use of high-intensity statins in combination with nonstatin agents such as ezetimibe, bempedoic acid, or proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. ^,,, The 2019 European Society of Cardiology/European Atherosclerosis Society guidelines are even more aggressive, recommending an LDL-C goal of <40 mg/dL for certain very high-risk groups.

Despite these guideline recommendations, real-world implementation of lipid-lowering therapy (LLT) is inconsistent. Large studies have demonstrated that 30% to 50% of patients with ASCVD are not prescribed any statin therapy, and, for those who are prescribed statins, many do not receive high-intensity doses or combination therapy when indicated. ^,, Moreover, routine LDL-C monitoring is inconsistently performed, leading to missed opportunities for therapy initiation and intensification. ^,, Patient- and clinician-related barriers, including perceived or actual statin-associated adverse events, cost and access challenges, limited awareness of LDL-C goals, and therapeutic inertia further contribute to poor adherence and treatment discontinuation. ^,, Collectively, these gaps result in a large percentage of patients with high ASCVD risk failing to achieve LDL-C targets, contributing to preventable cardiovascular events and health care expenditures. ^,

Digital health initiatives, such as mobile smartphone apps, can offer a key implementation strategy to overcome lipid management barriers and improve ASCVD prevention. ^,,,,, Mobile health interventions can deliver education, reminders, and self-management resources directly to patients, while simultaneously providing clinicians with data that can facilitate proactive, guideline-directed therapy adjustments. Evidence from other domains of cardiovascular prevention, such as hypertension and diabetes, suggests that digital health platforms can improve adherence, enhance risk factor control, and reduce hospitalizations. ^,,, However, lipid-specific digital health interventions remain relatively underexplored, leaving a critical gap in implementation science.

The Corrie platform was originally developed as a smartphone app to support recovery after acute myocardial infarction. In the MiCORE study, utilization of the Corrie digital health platform was associated with lower 30-day readmission rates and substantial health care cost savings compared with standard care, supporting the platform’s feasibility and value in secondary prevention. ^, Building on this foundation, the Corrie Lipids Program adapts and extends the platform to focus specifically on LDL-C management for patients at high risk for ASCVD. By combining patient-facing tools (LDL-C tracking, education, reminders) with clinician-facing support (virtual coaching, workflow integration), the program seeks to address the multilevel barriers that limit LLT optimization.

This manuscript describes the design of the Corrie Lipids Program, an implementation science study that integrates digital health technology with clinical practice to improve LDL-C goal attainment, enhance patient engagement, and strengthen clinician and patient adherence to guideline-directed lipid management. While observational registries have documented persistent gaps in lipid management and randomized controlled trials have demonstrated the efficacy of LLTs in preventing adverse cardiovascular events under controlled conditions, there is a critical gap in translating these findings into routine clinical practice, which the Corrie Lipids Program seeks to address. This study is guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to evaluate the impact and implementation of the Corrie Lipids Program. This model provides a strong foundation for integrating implementation science principles into lipid management.

Trial design

Overview, study sites, and digital health application

This is a prospective, multicenter implementation science initiative planned to be conducted initially at Johns Hopkins Medicine, Inova Schar Heart and Vascular, and Penn State Health, with plans to expand to additional centers in the future ( Figure 1 ). Eligible patients identified from hospital or outpatient clinics will be enrolled into the Corrie Lipids Program by their health care team. During their initial encounter, patients will be invited to download the Corrie app on their smartphone and will receive instructions on how to use the app. Throughout their participation in the program, patients will continue to receive routine clinical care, defined as the usual medical care provided regardless of participation in the program. In the Corrie app, patients can enter and track their LDL-C results, which will be recommended to be tested 4 to 12 weeks after changes in LLT and every 6 to 12 months once on stable LLT or upon reaching LDL-C goals. This is similar to recommendations for routine care; however, the patient-facing digital health app is hypothesized to improve patient experience and enhance medical care and follow-up regularity. At the end of the study, in-depth, semistructured interviews will be conducted with 25 patients and 5 clinicians who participated in the Corrie Lipids Program. No procedures will be performed as part of this study. Patients who elect not to enroll will not be used as a control group and will not be included in this study.

Study design. The frequency of lipid panel orders will depend on changes to prescribed LLT in addition to guideline-recommended LDL-C testing and monitoring (every 4–12 weeks after initiation or changes in LLT, and every 6–12 months once on stable LLT or upon reaching LDL-C goals). The study endpoints are at 6 months (primary outcome) and 12 months (secondary outcome) after enrollment in the Corrie Lipids Program. ASCVD , atherosclerotic cardiovascular disease; CVD , cardiovascular disease; LDL-C , low-density lipoprotein cholesterol; LLT , lipid-lowering therapy.

The Corrie Lipids Program has multiple components. First, a patient-facing digital health app with multiple supportive features allows patients to enter and track their LDL-C values, provides medication reminders, offers options to track vital parameters (eg, blood pressure, weight, step count, and exercise), and presents gamified educational articles and videos on ASCVD and LDL-C management, with the ultimate goal to increase patient engagement with their health ( Figure 2 ). Second, clinician support includes virtual coaching and education on guideline-directed therapy and decision-support for therapy intensification. Third, workflow integration aligns app prompts and LDL-C testing with clinical recommendations, reducing additional burden on clinicians. Clinicians can also access a web-based dashboard that keeps them informed on each patient’s vital signs, weight, step count, and exercise frequency, LDL-C levels over time, and engagement with the app ( Figure 3 ).

Smartphone app allowing patients to enter and track their LDL-C result history and goals, review educational videos and health tips, and record their medication uptake and other daily tasks. LDL-C , low-density lipoprotein cholesterol; PCSK9 , proprotein convertase subtilisin/kexin type 9.

Web-based dashboard allowing clinicians to track their patients’ medication adherence and LDL-C results, goals, and trends, as well as their own review of educational materials. LDL , low-density lipoprotein.

Patient population

We aim to enroll an initial cohort of 1,000 patients across 3 sites, anticipating approximately 700 patients will complete the 6- to 12-month follow-up. The target sample size was selected based on feasibility and to provide adequate precision for estimating key implementation outcomes. With 1,000 participants, a proportion of 50% can be estimated with a 95% confidence interval width of approximately ±3%.

Eligibility criteria include age ≥18 years, uncontrolled LDL-C per guideline-defined thresholds (defined as ≥100 mg/dL for primary prevention, and ≥70 mg/dL or ≥55 mg/dL for standard secondary prevention or very high risk ASCVD patients), ^,,,, ASCVD high-risk status (known or subclinical ASCVD diagnosed by imaging, familial hypercholesterolemia or LDL-C ≥190 mg/dL, diabetes mellitus, individuals who meet criteria for LLT based on ASCVD risk assessment in the most up-to-date guidelines, ^, or statin-intolerance), and ownership of a smartphone ( Table 1 ). Statin-intolerance was defined based on treating clinician assessment and documentation in the medical record, as well as guidance from contemporary definitions from the National Lipid Association’s scientific statement on statin intolerance. Patients could be statin-naïve or on stable LLT at baseline. Protocol changes will be made to account for the latest updates in guidelines on ASCVD risk assessment equations. Substantial cognitive or sensory impairment, pregnancy or breastfeeding, non-English speaking, and inability to provide informed consent are exclusion criteria.

Table 1

Inclusion and exclusion criteria.

Inclusion criteria
• Age ≥18 y
• Uncontrolled LDL-C per AHA/ACC guidelines
• At least 1 major cardiovascular risk factor:
– High risk for ASCVD (individuals who meet criteria for 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 verbal informed consent before initiation of any 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 y)
• 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

ACC , American College of Cardiology; AHA , American Heart Association; ASCVD , atherosclerotic cardiovascular disease; LDL-C , low-density lipoprotein cholesterol; LLT , lipid-lowering therapy.

Outcomes, data collection, and follow-up assessment

Assessment of outcomes is guided by the RE-AIM framework, not including maintenance due to the short timeline of the study. ^, The primary outcomes are (1) LDL-C goal achievement at 6 months to assess effectiveness of the program and (2) patient engagement with the app to evaluate the adoption of the program by patients ( Table 2 ). Secondary effectiveness outcomes include LDL-C goal achievement at 12 months, LLT prescribing patterns, and LDL-C testing frequency. Clinician adoption of the program, qualitative assessment of barriers and facilitators, and education-related clinician knowledge improvement will also be evaluated as secondary or exploratory outcomes of reach, implementation, and effectiveness, respectively.

Table 2

Study endpoints.

Endpoint	Description
Primary effectiveness, LDL-C goal achievement at 6 months	• Percentage of patients achieving LDL-C <100 mg/dL at 6 months for primary prevention • Percentage of patients achieving LDL-C <70 or 55 mg/dL at 6 months for secondary prevention • Average time from enrollment to LDL-C goal achievement
Primary adoption, patient engagement with app	• Percentage of patients downloading and engaging with the app (defined as completing an educational article or video) of those who were offered the app
Secondary effectiveness, LDL-C goal achievement at 12 months	• Percentage of patients achieving LDL-C <100 mg/dL at 12 months for primary prevention • Percentage of patients achieving LDL-C <70 or 55 mg/dL at 12 months for secondary prevention • Average time from enrollment to LDL-C goal achievement
Secondary effectiveness, LLT prescribing	• Percentage of patients prescribed statin and nonstatin therapies
Secondary effectiveness, LDL-C test ordering	• Percentage of patients ordered an LDL-C test
Secondary reach, clinician and patient uptake of Corrie Lipids Program	• Percentage of clinicians utilizing the program for their patients • Percentage of patients utilizing the app, including the amount of time they spend on the app, the features they use, and whether they continue to utilize the app over time • Descriptive findings on why patients and clinicians chose to adopt or not adopt the Corrie Lipids Program
Secondary implementation, site-specific implementation, and adaptations to the Corrie Lipids Program	• Descriptive findings of adaptations made to the implementation of the program at each study site
Exploratory effectiveness, LDL-C goal achievements in app users vs nonusers, and clinician knowledge improvement	• Percentage of patients who engaged with the app and achieved LDL-C goals at 12 months vs percentage of patients who did not engage with the app who achieved LDL-C goals at 12 months • Degree of improvement on knowledge assessments from pre- to postsurvey

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