Impact of the Corrie Lipids Digital Health Program on Lipid Optimization

ConditionsCardiovascular Risk LDL-C Lipids Digital Health Implementation Science

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Corrie Lipids Digital Health Program
Device
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.

Treatment groups

1,000 Participants

are divided into 1 treatment group

Group A: Corrie Lipids ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Percentage of participants achieving guideline-based LDL-C goals

LDL-C Goal Achievement assessed 6 months after enrollment in the Corrie Lipids program

Time frame

6 months, 12 months

Percentage of participants who download and engage with the Corrie app

Patient Engagement With the App defined as downloading and completing an educational article or video among those who were offered the app.

Time frame

6 months

Secondary outcomes

Percentage of patients prescribed statin and non-statin therapies

Lipid-Lowering Therapy Prescribing

Time frame

12 months

Percentage of patients ordered an LDL-C test

LDL-C Test Ordering

Time frame

12 months

Percentage of clinicians utilizing the program for patients

Clinician Uptake of Corrie Lipids Program

Time frame

12 months

Percentage of patients utilizing the app

Patient Uptake of Corrie Lipids Program. Percentage of patients utilizing the app (including the amount of time spent on the app, the features used, and whether patients continue to utilize the app over time)

Time frame

12 months

Other outcomes

Percentage of Patients LDL-C Goal Achievements in App (Users versus Non-Users)

Percentage of patients who engaged with the app and achieved LDL-C goals versus percentage of patients who did not engage with the app who achieved LDL-C goals

Time frame

12 months

Clinician Knowledge Improvement assessed by survey

Improvement on knowledge assessment from pre- to post- Corrie Lipids Program, measured by percentage of questions correct on knowledge assessment pre-program (baseline, time of enrollment) versus percentage of questions correct on knowledge assessment post-program.

Time frame

Baseline, 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Amgen

Collaborator

NewAmsterdam Pharma

Collaborator

Source ClinicalTrials.gov

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