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NCT01609842 · ClinicalTrials.gov registry record · NA
Hybrid Effectiveness-Implementation Study to Improve Clopidogrel Adherence
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 14,573
- Enrollment target
NCT01609842: Completed NA study, sponsored by VA Office of Research and Development.
NCT01609842 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 14,573 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01609842, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 14,573 participants
- Enrollment target
Study Summary
Percutaneous coronary intervention (PCI) is a common invasive cardiovascular procedure performed in the VA with over 13,000 procedures in FY10. Clopidogrel is a critical adjuvant therapy following PCI with stent placement and is generally recommended for up to 1 year following the procedure. Despite the evidence supporting clopidogrel use, studies both outside and within the VA suggest that poor adherence to clopidogrel is common. However, prior interventions targeting non-adherence have not specifically focused on clopidogrel adherence among PCI patients. There are many potential reasons for early clopidogrel discontinuation that involve patient and healthcare system factors. Patients reported the following reasons for discontinuing clopidogrel within 1 month after drug-eluting stent (DES) implantation: 1) misunderstanding the intended treatment duration; 2) conflicting recommendations about intended duration; 3) cost of the medication; and 4) patients' own decision to stop. In contrast, patients who continued to take clopidogrel reported the following as helpful: 1) communication such as letters from their physician; and 2) receiving specific instructions on clopidogrel use. These findings suggest that there are specific interventions that can be implemented to improve clopidogrel adherence. Multi-modal interventions that incorporate frequent follow-up, especially with pharmacists and use interactive voice response (IVR) technology have improved medication adherence. IVR technology is a computer-based telephone system which initiates calls, receives calls, provides information, and collects data from users. IVR is currently a mainstay in the VA where patients frequently interact with these automated systems to get clinic appointments and/or refill prescriptions. IVR as part of multi-modal interventions have been well received by patients, increased adherence to medications (e.g., statins), and improved clinical outcomes (e.g., blood pressure, diabetes symptoms,
Interventions
- OTHER Multifaceted Intervention with pharmacist and IVR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,573 participants |
| Start Date | 2014-01-20 |
| Est. Completion | 2022-02-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01609842
The ClinicalTrials.gov registry entry for NCT01609842 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14,573 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 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Multifaceted Intervention with pharmacist and IVR is the first listed.
NCT01609842 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01609842 about?
NCT01609842 is a clinical study titled "Hybrid Effectiveness-Implementation Study to Improve Clopidogrel Adherence". Percutaneous coronary intervention (PCI) is a common invasive cardiovascular procedure performed in the VA with over 13,000 procedures in FY10. Clopidogrel is a critical adjuvant therapy following PCI with stent placement and is generally recommended for up to 1 year following the procedure. Despite...
What is the current status of trial NCT01609842?
This trial is currently completed. It is a NA study. The enrollment target is 14,573 participants. The study started on 2014-01-20. Estimated completion is 2022-02-07.
What interventions are being tested in trial NCT01609842?
The interventions under investigation include: Multifaceted Intervention with pharmacist and IVR (OTHER).
Who is sponsoring clinical trial NCT01609842?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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