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NCT00032591 · ClinicalTrials.gov registry record · Phase 4
The Home INR Study
A Phase 4 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 4
- Development phase
- 2,922
- Enrollment target
NCT00032591 is a Phase 4 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 2,922 participants.
The verdict
NCT00032591, a Phase 4 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,922 participants
- Enrollment target
Study Summary
Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.
Interventions
- PROCEDURE Weekly patient self-testing of prothrombin time
- OTHER High quality anticoagulation management (HQACM) with conventional monthly testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,922 participants |
| Start Date | 2003-08 |
| Est. Completion | 2008-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00032591
The ClinicalTrials.gov registry entry for NCT00032591 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 2,922 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Weekly patient self-testing of prothrombin time is the first listed.
NCT00032591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00032591 about?
NCT00032591 is a clinical study titled "The Home INR Study". Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patie...
What is the current status of trial NCT00032591?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,922 participants. The study started on 2003-08. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00032591?
The interventions under investigation include: Weekly patient self-testing of prothrombin time (PROCEDURE), High quality anticoagulation management (HQACM) with conventional monthly testing (OTHER).
Who is sponsoring clinical trial NCT00032591?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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