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NCT01578044 · ClinicalTrials.gov registry record · NA
Dabigatran Adherence Pilot Intervention for Patients With Atrial Fibrillation
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT01578044: Completed NA study, sponsored by VA Office of Research and Development.
NCT01578044 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01578044, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Atrial fibrillation is common and increases the risk of clotting especially in patients with multiple clotting risk factors. Patients treated with warfarin, an oral anti-coagulant, require frequent lab monitoring and dose adjustments and are managed in pharmacy staffed anti-coagulation clinics that routinely contact them to remind them about blood draws, re-enforce medication adherence, and adjust dosing based on labs. Dabigatran, a newly approved medication that may be better for some with atrial fibrillation to lower risk of stroke and clotting, has been found to have fewer drug problems and eliminates lab monitoring need. Following instructions for taking dabigatran is important because it is a twice daily medication requiring monthly refills. Rivaroxaban is a once daily, newly approved Factor Xa inhibitor oral medication, prescribed to reduce risk of stroke and systemic embolism among patients with atrial fibrillation. Apixaban is a twice daily, FDA approved Factor Xa inhibitor oral anticoagulant, prescribed to reduce the risk of stroke and blood clots among patients with atrial fibrillation. In a double-blind RCT, apixaban was found to be superior to warfarin in reducing stroke, systemic embolism, and death. Patients on dabigatran, rivaroxaban, and apixaban will not be followed in anti-coagulation clinics, therefore will not benefit from the support provided by these clinics. It's anticipated many patients will be switched to dabigatran, rivaroxaban, or apixaban following recent publication of criteria for dabigatran use from the VA National Pharmacy Benefits Management Program, providing an opportune time to conduct the proposed adherence study. We will conduct qualitative interviews with patients(n\~30) and pharmacists(n\~20) to understand barriers/facilitators to oral anticoagulant adherence. Informed by the findings, we will develop and pilot test a multi faceted intervention to improve adherence among patients recently started on dabigatran/rivaroxaban/a
Interventions
- OTHER Control
- BEHAVIORAL Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01578044
The ClinicalTrials.gov registry entry for NCT01578044 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 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 2 interventions - of which Control is the first listed.
NCT01578044 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01578044 about?
NCT01578044 is a clinical study titled "Dabigatran Adherence Pilot Intervention for Patients With Atrial Fibrillation". Atrial fibrillation is common and increases the risk of clotting especially in patients with multiple clotting risk factors. Patients treated with warfarin, an oral anti-coagulant, require frequent lab monitoring and dose adjustments and are managed in pharmacy staffed anti-coagulation clinics that ...
What is the current status of trial NCT01578044?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2012-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01578044?
The interventions under investigation include: Control (OTHER), Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01578044?
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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