Cardiovascular Risk, Digital Health, Implementation Science, LDL-C, Lipids
Conditions
Keywords
Apolipoprotein B (apoB), Lipoprotein-a (Lp(a)
Brief summary
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
DEVICECorrie 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.
Sponsors
Johns Hopkins University
Amgen
NewAmsterdam Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving guideline-based LDL-C goals | 6 months, 12 months | LDL-C Goal Achievement assessed 6 months after enrollment in the Corrie Lipids program |
| Percentage of participants who download and engage with the Corrie app | 6 months | Patient Engagement With the App defined as downloading and completing an educational article or video among those who were offered the app. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients prescribed statin and non-statin therapies | 12 months | Lipid-Lowering Therapy Prescribing |
| Percentage of patients ordered an LDL-C test | 12 months | LDL-C Test Ordering |
| Percentage of clinicians utilizing the program for patients | 12 months | Clinician Uptake of Corrie Lipids Program |
| Percentage of patients utilizing the app | 12 months | 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) |
Countries
United States
Contacts
CONTACTFrancoise Marvel, MD
PRINCIPAL_INVESTIGATORStacey Schott, MD, MPH
Johns Hopkins University
Outcome results
None listed