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Trial record 78 of 226 for:    warfarin AND International

Assessing the Ability of Warfarin Treated Patients to Predict Their INR

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ClinicalTrials.gov Identifier: NCT02764112
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
Jim Hoehns, Northeast Iowa Medical Education Foundation

Brief 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.


Condition or disease
Atrial Fibrillation

Detailed 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.


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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Assessing the Ability of Warfarin Treated Patients to Predict Their INR
Study Start Date : October 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners




Primary Outcome Measures :
  1. Assess factors which influence INR predictions [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In this prospective study, we will enroll warfarin treated patients from 8 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764112


Locations
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United States, Iowa
Northeast Iowa Family Practice
Waterloo, Iowa, United States, 50702
Sponsors and Collaborators
Northeast Iowa Medical Education Foundation
University of Iowa

Publications of Results:
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Responsible Party: Jim Hoehns, Research Director, Northeast Iowa Medical Education Foundation
ClinicalTrials.gov Identifier: NCT02764112     History of Changes
Other Study ID Numbers: 914
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jim Hoehns, Northeast Iowa Medical Education Foundation:
warfarin
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants