NCT04766216

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

February 16, 2021

Last Update Submit

May 6, 2024

Conditions

Atrial FibrillationVenous ThromboembolismHeart Valve Diseases

Keywords

WarfarinSelf-managementImplementation scienceAnticoagulants

Outcome Measures

Primary Outcomes (2)

  • Time in therapeutic INR range (TTR)

    Percent time INR in the therapeutic range

    Change from baseline at 6 months

  • Percent of patients transitioned to patient self-management

    Percent of patients successfully transitioned to warfarin patient self-management

    6-months follow up

Secondary Outcomes (5)

  • Episodes of major bleeding

    6-months follow up

  • Episodes of thromboembolic complications

    6-months follow

  • Mental and physical health-related quality of life scores

    Change from baseline at 6 months

  • Anticoagulation therapy knowledge scores

    Change from baseline at 6 months

  • Patient satisfaction survey scores

    Change from baseline at 6 months

Other Outcomes (1)

  • Patient self-management cost effectiveness

    3-month cycles

Study Arms (2)

Warfarin Patient Self-Management

EXPERIMENTAL

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

Other: Patient self-management

Historical Control

ACTIVE COMPARATOR

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

Other: Usual care provided by anticoagulation providers

Interventions

Patient self-managementOTHER

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

Warfarin Patient Self-Management
Usual care provided by anticoagulation providersOTHER

Normal care provided by anticoagulation providers

Historical Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA Loma Linda Healthcare System

Loma Linda, California, 92357, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

COMPLETED

University of Michigan

Ann Arbor, Michigan, 48109, United States

COMPLETED

University of Utah Thrombosis Center

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationVenous ThromboembolismHeart Valve Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsThromboembolismEmbolism and ThrombosisVascular Diseases

Central Study Contacts

Daniel M Witt, PharmD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair, Department of Pharmacotherapy

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 23, 2021

Study Start

March 15, 2023

Primary Completion

May 31, 2024

Study Completion

April 30, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(4)