Assessing the Ability of Warfarin Treated Patients to Predict Their INR

Atrial Fibrillation Clinical Trial

Official title:

Assessing the Ability of Warfarin Treated Patients to Predict Their INR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764112
• Other study ID #: 914
• Status: Completed
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: June 2019
• Source: Northeast Iowa Medical Education Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

ASSESSING THE ABILITY OF WARFARIN TREATED PATIENTS TO PREDICT THEIR INR Kathleen McNamara, James Hoehns, Matthew Witry

The international normalized ratio (INR) is the accepted lab test used to measure the intensity of warfarin effect. The conventional wisdom is that patients receiving warfarin are unable to correctly determine, in the absence of an INR result, whether or not they are therapeutic at any given time. Some warfarin treated patients express that they have insight into what their INR result will be. Various patient related factors may contribute to these opinions.

Our objective is to assess how accurately patients can guess their INR result before it is obtained and to describe factors which inform their opinion of what their INR will be.

Description:

ASSESSING THE ABILITY OF WARFARIN TREATED PATIENTS TO PREDICT THEIR INR Kathleen McNamara, James Hoehns, Matthew Witry

The international normalized ratio (INR) is the accepted lab test used to measure the intensity of warfarin effect. The conventional wisdom is that patients receiving warfarin are unable to correctly determine, in the absence of an INR result, whether or not they are therapeutic at any given time. Some warfarin treated patients express that they have insight into what their INR result will be. Various patient related factors may contribute to these opinions.

Our objective is to assess how accurately patients can guess their INR result before it is obtained and to describe factors which inform their opinion of what their INR will be. In this prospective study, the investigators will enroll warfarin treated patients from 7 anticoagulation clinics in Iowa. Inclusion criteria are: age ≥18 years, warfarin use ≥60 days, INR goal of 2.0-3.0 or 2.5-3.5, expected warfarin use >6 months, and English speaking. Exclusion criteria include: use of self INR-testing, home INR draws, dementia, or residing in a long-term care facility. A data collection form will be completed prior to INR measurement for a 6 month period. Information will be collected for subject demographics, warfarin adherence, INR stability, INR prediction, and prediction rationale.

INR monitoring represents a significant burden with respect to cost and time. The results of this study may identify patient factors which could help individualize and decrease the frequency of INR monitoring in patients who receive maintenance warfarin therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Warfarin use =60 days

• INR goal of 2.0-3.0 or 2.5-3.5

• Expected warfarin use >6 months

• English speaking

Exclusion Criteria:

• Self INR-testing

• Home INR draws

• Dementia

• Residence of a long-term care facility

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	Northeast Iowa Family Practice	Waterloo	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Northeast Iowa Medical Education Foundation	University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (1)

McNamara K, Witry M, Bryant G, Koenigsfeld C, Lehman N, Logemann C, Mormann M, Rueber A, Herring M, Hoehns JD. A prospective, multi-center cohort study: investigating the ability of warfarin-treated patients to predict their INR. Clin Res Cardiol. 2019 Fe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess factors which influence INR predictions	Patients will be asked to predict their INR value prior to having it tested. We will record patient's INR prediction and the value we obtain after testing INR.	6 months