Recruiting

Warfarin

Sponsor:

University of Utah

Code:

NCT04766216

Conditions

Atrial Fibrillation

Venous Thromboembolism

Heart Valve Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient self-management

Usual care provided by anticoagulation providers

Study Details

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 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 ID

NCT04766216

Start date

Mar 15, 2023

Status verified date

May, 2024

Completion date

Apr 30, 2025

Anticipated

Primary completion date

May 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Warfarin Patient Self-Management

Patients managing decisions relating to warfarin dose and next INR test based on the results of current INR test

active comparator: Historical Control

Patients managed by anticoagulation providers prior to transitioning to warfarin patient self-management

Interventions

Patient self-management

Patient makes independent decisions regarding warfarin therapy changes using warfarin dosing tools

Usual care provided by anticoagulation providers

Normal care provided by anticoagulation providers

Primary outcome measure

  • Time in therapeutic INR range (TTR) [ Time Frame: Change from baseline at 6 months ]
  • Percent of patients transitioned to patient self-management [ Time Frame: 6-months follow up ]

Central Contacts and Locations

Central contacts

Daniel M Witt, PharmD

801-581-8851dan.witt@pharm.utah.edu

Locations

VA Loma Linda Healthcare System

Recruiting

Loma Linda, California, United States, 92357

Contacts

Linh Chan, PharmD

909-894-7996Linh.Chan@va.gov

University of Utah Thrombosis Center

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Sara Vazquez, PharmD

801-581-3449sara.vazquez@hsc.utah.edu

Daniel M Witt, PharmD

801-581-8851dan.witt@pharm.utah.edu

More Information

Sponsor

University of Utah

Last update posted

May 8, 2024

Last verified

May, 2024

Keywords

  • Warfarin
  • Self-management
  • Implementation science
  • Anticoagulants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2024-05-08.