Assessing the Ability of Warfarin Treated Patients to Predict Their INR

NCT02764112 | Completed

• 1 other identifier: 914
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

warfarin

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Self INR-testing
• Home INR draws
• Dementia
• Residence of a long-term care facility

Sponsors & Collaborators

• Northeast Iowa Medical Education Foundation: lead
• University of Iowa: collaborator

Study Sites (1)

Northeast Iowa Family Practice

Waterloo, Iowa, 50702, United States

Location

Related 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 Feb;108(2):212-217. doi: 10.1007/s00392-018-1345-9. Epub 2018 Aug 8.

  PMID: 30091085 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: May 6, 2016
• Study Start: October 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)