RECRUITING

Warfarin Patient Self-management Implementation in the US Healthcare System

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

Overcoming Barriers to Warfarin Patient Self-management Implementation in the US Healthcare System

Quick Facts

Study Start:2023-03-15
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04766216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age treated with warfarin for any indication for at least 9 months prior to enrollment
  2. * 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)
  3. * Willing to make independent decisions about warfarin dosing based on INR results
  4. * Able to perform INR tests at least every 2 weeks
  5. * Currently have and willing to maintain internet access for the duration of the study in order to complete online data collection forms
  6. * Have an anticipated duration of warfarin therapy of at least 6 months
  1. * Goal INR range other than 2.0-3.0 or 2.5-3.5
  2. * Known poor adherence to warfarin therapy
  3. * Non-English speaking
  4. * Inability or refusal to provide written informed consent

Contacts and Locations

Study Contact

Daniel M Witt, PharmD
CONTACT
801-581-8851
dan.witt@pharm.utah.edu

Study Locations (Sites)

VA Loma Linda Healthcare System
Loma Linda, California, 92357
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Utah Thrombosis Center
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: University of Utah

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

Study Start Date2023-03-15
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2023-03-15
Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

  • Warfarin
  • Self-management
  • Implementation science
  • Anticoagulants

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Venous Thromboembolism
  • Heart Valve Diseases