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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
Have an anticipated duration of warfarin therapy of at least 6 months
Be older than 18 years old
Must not have
Non-English speaking
Goal INR range other than 2.0-3.0 or 2.5-3.5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months follow
Awards & highlights
No Placebo-Only Group

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.
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.
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 expected to be on warfarin for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English.
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My target INR is not between 2.0-3.0 or 2.5-3.5.
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I have had trouble following my warfarin treatment plan.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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?

University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,471 Total Patients Enrolled
12 Trials studying Atrial Fibrillation
1,912 Patients Enrolled for Atrial Fibrillation
Brigham and Women's HospitalOTHER
1,669 Previous Clinical Trials
11,877,666 Total Patients Enrolled
35 Trials studying Atrial Fibrillation
2,052,456 Patients Enrolled for Atrial Fibrillation
Kaiser Foundation Research InstituteOTHER
27 Previous Clinical Trials
21,146 Total Patients Enrolled
University of MichiganOTHER
1,862 Previous Clinical Trials
6,440,967 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
7,132 Patients Enrolled for Atrial Fibrillation
Tennessee Valley Health Systems Veterans Affairs Medical CenterUNKNOWN
VA Loma Linda Health Care SystemFED
9 Previous Clinical Trials
620 Total Patients Enrolled

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
~55 spots leftby Dec 2025
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