Cardiovascular RiskNCT07478887
Impact of the Corrie Lipids Digital Health Program on Lipid Optimization
A study testing Corrie Lipids Digital Health Program in people with Cardiovascular Risk and LDL-C, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk, LDL-C, Lipids
- What is being tested?
- Corrie Lipids Digital Health Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Francoise Marvel, MD, 410-502-0469, fmarvel1@jhmi.edu
About this study
Official title: Corrie Lipids Program: Optimizing LDL-Cholesterol by Improving Awareness, Access, and Achievement
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
- Cardiovascular Risk, LDL-C, Lipids, Digital Health, Implementation Science
- Being tested
- Corrie Lipids Digital Health Program
- Keywords
- Apolipoprotein B (apoB), Lipoprotein-a (Lp(a)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corrie Lipids Digital Health ProgramDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Corrie Lipids Program | Experimental | Multicomponent digital health lipid management and education program Receives: Device: Corrie Lipids Digital Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving guideline-based LDL-C goals
LDL-C Goal Achievement assessed 6 months after enrollment in the Corrie Lipids program
Measured: 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.
Measured: 6 months
Secondary outcomes (4)
Percentage of patients prescribed statin and non-statin therapies
Lipid-Lowering Therapy Prescribing
Measured: 12 months
Percentage of patients ordered an LDL-C test
LDL-C Test Ordering
Measured: 12 months
Percentage of clinicians utilizing the program for patients
Clinician Uptake of Corrie Lipids Program
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start20 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular RiskStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, NewAmsterdam Pharma
- Responsible party
- Sponsor
- Investigators
- Stacey Schott, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478887
- Sponsor's protocol ID
- IRB00476278
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41935556
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corrie Lipids Program: Optimizing LDL-Cholesterol by Improving Awareness, Access, and Achievement
- ClinicalTrials.gov ID
- NCT07478887
- Acronym / sponsor ID
- IRB00476278
- Conditions
- Cardiovascular Risk, LDL-C, Lipids, Digital Health, Implementation Science
- Keywords
- Apolipoprotein B (apoB), Lipoprotein-a (Lp(a)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Amgen, NewAmsterdam Pharma
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corrie Lipids Program | Experimental | Device: Corrie Lipids Digital Health ProgramMulticomponent digital health lipid management and education program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corrie Lipids Digital Health ProgramThe 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. | Device | Corrie Lipids Program |
Primary outcome
Percentage of participants achieving guideline-based LDL-C goals
Time frame: 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
Time frame: 6 months
Patient Engagement With the App defined as downloading and completing an educational article or video among those who were offered the app.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 41935556Peng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stacey Schott, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corrie Lipids Digital Health Program in people with Cardiovascular Risk and LDL-C, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francoise Marvel, MD (410-502-0469, fmarvel1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants achieving guideline-based LDL-C goals (time frame: 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07478887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.