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Completed

NCT Number: NCT02764112

Assessing the Ability of Warfarin Treated Patients to Predict Their INR

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northeast Iowa Family Practice

Waterloo, Iowa, 50702, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northeast Iowa Medical Education Foundation

Other

Collaborators

  • University of Iowa

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 6, 2016
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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