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Warfarin Self-Management for Anticoagulation Therapy

N/A
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age treated with warfarin for any indication for at least 9 months prior to enrollment
Have an anticipated duration of warfarin therapy of at least 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months follow
Awards & highlights

Study Summary

This trial is testing whether letting patients manage their own warfarin therapy is less burdensome, less expensive, and safer than standard clinic-directed warfarin management.

Who is the study for?
This trial is for adults over 18 who have been on warfarin for at least 9 months, need to maintain an INR range of 2.0-3.5, and are willing to self-manage their treatment with home monitoring or clinic results. They must be able to make dosing decisions, test their INR every two weeks minimum, and have internet access.Check my eligibility
What is being tested?
The study compares patient self-management of warfarin therapy using home INR monitoring devices against the usual care by clinics. It aims to see if patients can safely manage their own treatment effectively and less expensively.See study design
What are the potential side effects?
While not explicitly stated in this summary, typical side effects of warfarin include bleeding problems, bruising easily, headaches, stomach pain or bloating; however these may vary based on individual management practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and have been on warfarin for at least 9 months.
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I am expected to be on warfarin for at least 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months follow
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months follow for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of patients transitioned to patient self-management
Time in therapeutic INR range (TTR)
Secondary outcome measures
Anticoagulation therapy knowledge scores
Episodes of major bleeding
Episodes of thromboembolic complications
+2 more
Other outcome measures
Patient self-management cost effectiveness

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Warfarin Patient Self-ManagementExperimental Treatment1 Intervention
Patients managing decisions relating to warfarin dose and next INR test based on the results of current INR test
Group II: Historical ControlActive Control1 Intervention
Patients managed by anticoagulation providers prior to transitioning to warfarin patient self-management

Find a Location

Who is running the clinical trial?

Kaiser Foundation Research InstituteOTHER
27 Previous Clinical Trials
21,146 Total Patients Enrolled
University of MichiganOTHER
1,787 Previous Clinical Trials
6,365,384 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
7,132 Patients Enrolled for Atrial Fibrillation
Tennessee Valley Health Systems Veterans Affairs Medical CenterUNKNOWN

Media Library

Patient self-management (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04766216 — N/A
Atrial Fibrillation Research Study Groups: Warfarin Patient Self-Management, Historical Control
Atrial Fibrillation Clinical Trial 2023: Patient self-management Highlights & Side Effects. Trial Name: NCT04766216 — N/A
Patient self-management (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04766216 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals is this trial attempting to achieve?

"This clinical trial, tracked over a 6-month period, is focused on attaining Time in therapeutic INR range (TTR). Secondary goals include assessing Episodes of thromboembolic complications, Episodes of major bleeding as defined by the ISTH definition, and Anticoagulation therapy knowledge scores generated from an Anticoagulation Knowledge Survey Tool."

Answered by AI

Is enrollment for this trial still open?

"The clinicaltrial.gov website confirms that this medical study is not enrolling patients at present, though it was initially posted on September 1st 2022 and updated last on the 27th of September 2021. Nonetheless, there are 603 other trials actively recruiting individuals as we speak."

Answered by AI
~75 spots leftby Mar 2025