Assessing the Ability of Warfarin Treated Patients to Predict Their INR

Sponsor
Northeast Iowa Medical Education Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT02764112
Collaborator
University of Iowa (Other)
87
1
9
9.7

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    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 :
    Oct 1, 2015
    Actual Primary Completion Date :
    Jul 1, 2016
    Actual Study Completion Date :
    Jul 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Assess factors which influence INR predictions [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northeast Iowa Family Practice Waterloo Iowa United States 50702

    Sponsors and Collaborators

    • Northeast Iowa Medical Education Foundation
    • University of Iowa

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jim Hoehns, Research Director, Northeast Iowa Medical Education Foundation
    ClinicalTrials.gov Identifier:
    NCT02764112
    Other Study ID Numbers:
    • 914
    First Posted:
    May 6, 2016
    Last Update Posted:
    Jun 27, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Jim Hoehns, Research Director, Northeast Iowa Medical Education Foundation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 27, 2019