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ACTIVE NOT RECRUITING NA

Secondary Event Prevention Using Population Risk Management After PCI and for Anti-Rheumatic Medications

NCT02694185 · View on ClinicalTrials.gov ↗

Study Summary

Ischemic heart disease (IHD) and its treatment carry profound public health and economic implications. Among Veterans, IHD represents one of the most common causes of death and disability, with over 500,000 affected individuals' annually. Rheumatic disease, though far less common than IHD can affect multiple organ systems and requires therapies costing in excess of $50,000 a year. Optimal treatment of Veterans with IHD and rheumatic disease requires a number of medications to maintain or improve health. Not taking medications as prescribed, however, is common and increases the risk of subsequent adverse events (cardiac death and myocardial infarction \[MI\]). To improve medication adherence rates and the cardiac health of Veterans with IHD, the investigators propose to test a medication adherence intervention. Known as VA SEPPRMACI-ARM (Secondary Event Prevention using Population Risk Management After PCI and for Anti-Rheumatic Medications), this intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals if they have not refilled their medication a given number of days after it was due for refill. The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients not completing SMS and then IVR by not refilling their medication (or declining SMS and not completing IVR) escalate to a trained research interventionalist. The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient. The investigators will test the intervention on IHD patients who have recently undergone PCI-a cardiac procedure commonly used among IHD patients to improve the heart's blood flow and in patients starting anti-rheumatic m

Interventions

  • OTHER Caplan IVR

Study Locations (5)

California

  • San Francisco VA Medical Center, San Francisco, CA — San Francisco

Colorado

  • Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora

Maryland

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore

North Carolina

  • Durham VA Medical Center, Durham, NC — Durham

Other

  • VA Caribbean Healthcare System, San Juan, PR — San Juan

Trial Details

FieldValue
Enrollment Target 5,269 participants
Start Date 2016-10-01
Est. Completion 2025-02-28
Phase NA

Sponsor

VA Office of Research and Development

1,863 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02694185

The ClinicalTrials.gov registry entry for NCT02694185 describes a study currently listed as active not recruiting. 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 5,269 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 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 Myocardial Ischemia appearing as the primary indexed condition, and to 1 intervention — of which Caplan IVR 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: NCT02694185 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Colorado, Maryland. 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 NCT02694185 about?

NCT02694185 is a clinical study titled "Secondary Event Prevention Using Population Risk Management After PCI and for Anti-Rheumatic Medications". Ischemic heart disease (IHD) and its treatment carry profound public health and economic implications. Among Veterans, IHD represents one of the most common causes of death and disability, with over 500,000 affected individuals' annually. Rheumatic disease, though far less common than IHD can affect...

What is the current status of trial NCT02694185?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 5,269 participants. The study started on 2016-10-01. Estimated completion is 2025-02-28.

What conditions does trial NCT02694185 study?

This clinical trial studies the following conditions: Myocardial Ischemia, Rheumatic Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02694185?

The interventions under investigation include: Caplan IVR (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02694185?

This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02694185 being conducted?

This trial has 5 study locations across California, Colorado, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial