Assessing the Ability of Warfarin Treated Patients to Predict Their INR
NCT ID: NCT02764112
Last Updated: 2019-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
87 participants
OBSERVATIONAL
2015-10-31
2016-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Home INR draws
* Dementia
* Residence of a long-term care facility
18 Years
ALL
No
Sponsors
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University of Iowa
OTHER
Northeast Iowa Medical Education Foundation
OTHER
Responsible Party
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Jim Hoehns
Research Director
Locations
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Northeast Iowa Family Practice
Waterloo, Iowa, United States
Countries
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References
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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 Feb;108(2):212-217. doi: 10.1007/s00392-018-1345-9. Epub 2018 Aug 8.
Other Identifiers
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914
Identifier Type: -
Identifier Source: org_study_id
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