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Reducing Disparities in Primary Prevention of Cardiovascular Disease
NCT01610609 · View on ClinicalTrials.gov ↗
Study Summary
Cardiovascular disease (CVD) is the leading cause of disparities in years of life lost by race and low socioeconomic status. Statins have been shown to decrease the risk of cardiovascular events among individuals with high CVD risk. Yet, despite increased statin use and overall declining CVD rates, disparities in statin use and disparities in the control of high cholesterol by race, ethnicity, and socioeconomic status have persisted. Objective: To improve the appropriate use of statins for primary cardiovascular disease prevention among high risk individuals at community health centers through a system of population health management that uses electronic health record (EHR) data to identify patients for targeted education and outreach. Aim 1: Conduct a randomized controlled trial among individuals with 10-year risk for myocardial infarction or coronary death of 10% or higher to determine if the population health management intervention, compared to usual care, results in higher rates of documented statin treatment discussions within 6 months (primary process outcome), higher rates of statin prescribing within 6 months (secondary process outcome), and higher rates of significant low-density lipoprotein cholesterol (LDL-C) lowering defined as a follow up LDL-C ≥30 mg/dL lower than baseline (primary clinical outcome). Aim 2: Interview patients who received the intervention to identify barriers to success Aim 3: Assess the overall costs of the intervention and the costs per each patient who achieves significant LDL-C lowering compared to patient who received usual care.
Conditions Studied
Interventions
- BEHAVIORAL Population Health Management Intervention
Study Locations (3)
Illinois
- Near North Health Service Corporation — Chicago
- Heartland Health Outreach — Chicago
Arizona
- North Country Health Care — Flagstaff
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 646 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01610609
The ClinicalTrials.gov registry entry for NCT01610609 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 646 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,033 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention — of which Population Health Management Intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01610609 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Illinois, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01610609 about?
NCT01610609 is a clinical study titled "Reducing Disparities in Primary Prevention of Cardiovascular Disease". Cardiovascular disease (CVD) is the leading cause of disparities in years of life lost by race and low socioeconomic status. Statins have been shown to decrease the risk of cardiovascular events among individuals with high CVD risk. Yet, despite increased statin use and overall declining CVD rates, ...
What is the current status of trial NCT01610609?
This trial is currently completed. It is a NA study. The enrollment target is 646 participants. The study started on 2012-06. Estimated completion is 2014-07.
What conditions does trial NCT01610609 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Cholesterol, LDL. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01610609?
The interventions under investigation include: Population Health Management Intervention (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01610609?
This trial is sponsored by Northwestern University, which has 1,033 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01610609 being conducted?
This trial has 3 study locations across Arizona, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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