RECRUITING
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Warfarin Patient Self-management Implementation in the US Healthcare System
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 management. The long-term objective of our application is to improve the safety of ambulatory warfarin therapy through increasing the implementation of PSM.
Conditions:
🦠 Atrial Fibrillation 🦠 Venous Thromboembolism 🦠 Heart Valve Diseases
🗓️ Study Start (Actual) 15 March 2023
🗓️ Primary Completion (Estimated) 31 May 2024
✅ Study Completion (Estimated) 30 April 2025
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Loma Linda, California, United States
📍 Boston, Massachusetts, United States
📍 Ann Arbor, Michigan, United States
📍 Salt Lake City, Utah, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 February 2021
  • First Submitted that Met QC Criteria 19 February 2021
  • First Posted 23 February 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 May 2024
  • Last Update Posted 8 May 2024
  • Last Verified May 2024
I'm interested ...!!