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Warfarin Patient Self-management Study

This study is looking at how to better implement patient self-management (PSM) for people taking warfarin, a medication used to prevent blood clots in conditions like atrial fibrillation (an irregular heartbeat), venous thromboembolism (blood clots in veins), and heart valve diseases. Currently, PSM is not widely used in the US, even though it can be safer and more convenient than standard care. The study aims to understand why PSM isn't used more often and to test ways to increase its use. You might be able to join if you are at least 18 years old, have been taking warfarin for at least 9 months, and are willing to test your own INR (International Normalized Ratio, a measure of how quickly your blood clots) at home or have quick access to clinic results. Success in this study will be measured by how well patients keep their INR in the target range and how many patients transition to self-management. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 150 participants. It compares patient self-management of warfarin to usual care provided by anticoagulation providers.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures changes from baseline at 6 months for time in therapeutic INR range and the percentage of patients transitioned to patient self-management.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04766216

Warfarin Patient Self-management Implementation in the US Healthcare System

UNKNOWN
NAAges 18+InterventionalTreatment
University of Utah
~150 participants
Updated 2024-05-08 on ClinicalTrials.gov
What's tested:Patient self-managementUsual care provided by anticoagulation providers

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time in therapeutic INR range (TTR)
Measured over Change from baseline at 6 months
+1 more outcome measured

Conditions

Atrial Fibrillation
Venous Thromboembolism
Heart Valve Diseases

Explore related trials

Atrial FibrillationValvular Heart DisorderVenous Thromboembolism

Where it's being run

4 sites across 4 states
California1
Massachusetts1
Michigan1
Utah1

Who to contact

Daniel M Witt, PharmD
[email protected]
801-581-8851
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Time in therapeutic INR range (TTR)Change from baseline at 6 months

    Percent time INR in the therapeutic range

  • Percent of patients transitioned to patient self-management6-months follow up

    Percent of patients successfully transitioned to warfarin patient self-management