Status:
RECRUITING
Warfarin Patient Self-management Implementation in the US Healthcare System
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Brigham and Women's Hospital
University of Michigan
Conditions:
Atrial Fibrillation
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In the US, patients receiving warfarin therapy are rarely allowed to engage in patient self-management (PSM) which is less burdensome, less expensive, and safer than standard clinic-directed warfarin ...
Detailed Description
In the US, patients receiving warfarin therapy are rarely allowed to engage in patient self-management (PSM) which is less burdensome, less expensive, and safer than standard clinician-directed warfar...
Eligibility Criteria
Inclusion
- At least 18 years of age treated with warfarin for any indication for at least 9 months prior to enrollment
- Demonstrate the willingness and ability to test their own INR using a home INR monitoring device or have same-day access to clinic-derived INR results (e.g., via electronic medical record secure messaging)
- Willing to make independent decisions about warfarin dosing based on INR results
- Able to perform INR tests at least every 2 weeks
- Currently have and willing to maintain internet access for the duration of the study in order to complete online data collection forms
- Have an anticipated duration of warfarin therapy of at least 6 months
Exclusion
- Goal INR range other than 2.0-3.0 or 2.5-3.5
- Known poor adherence to warfarin therapy
- Non-English speaking
- Inability or refusal to provide written informed consent
Key Trial Info
Start Date :
March 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04766216
Start Date
March 15 2023
End Date
April 30 2025
Last Update
May 8 2024
Active Locations (4)
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1
VA Loma Linda Healthcare System
Loma Linda, California, United States, 92357
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
University of Utah Thrombosis Center
Salt Lake City, Utah, United States, 84112