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NCT02694185 · ClinicalTrials.gov registry record · NA
Secondary Event Prevention Using Population Risk Management After PCI and for Anti-Rheumatic Medications
A NA study of Myocardial Ischemia and Rheumatic Diseases, sponsored by VA Office of Research and Development.
- Active
- Registry status
- NA
- Development phase
- 5,269
- Enrollment target
- 5
- Study locations
NCT02694185: Active NA study of Myocardial Ischemia and Rheumatic Diseases, sponsored by VA Office of Research and Development.
NCT02694185 is a NA study of Myocardial Ischemia and Rheumatic Diseases that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 5,269 participants, above the 1,956-participant average among 29 other Myocardial Ischemia trials with a reported enrollment target (169% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02694185, a NA study of Myocardial Ischemia and Rheumatic Diseases, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 5,269 participants
- Enrollment target
- 5
- Study locations
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
Primary Outcome
Proportion of Days Covered (PDC) is measured by looking at the number of doses of medication a patient has versus days in the month (if a patient has 20 days of medication for a 30 day period their PDC is 20/30, 2/3, or 66.7%). Used to assess the effectiveness of the intervention, PDC will be tested among IHD patients in the year after PCI and among rheumatology clinic patients chronically prescribed DMARDs.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 5,269 participants |
| Start Date | 2016-10-01 |
| Est. Completion | 2025-02-28 |
| Phase | NA |
What the registry record for NCT02694185 still lists
NCT02694185 is an interventional study that assigns participants to a tested intervention. Its 5,269 participants enrollment target places it among the larger protocols in the corpus, above the 1,956-participant average among 29 other Myocardial Ischemia trials with a reported enrollment target (169% higher).
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.
NCT02694185 lists 5 locations in 5 states (California, Colorado, Maryland).
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.
What interventions are being tested in trial NCT02694185?
The interventions under investigation include: Caplan IVR (OTHER).
Who is sponsoring clinical trial NCT02694185?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Myocardial Ischemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02694185's enrollment target sits among peer trials
5,269 4th of 29 higher than 26 of 29 other Myocardial Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myocardial Ischemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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