MedTrace Logo

Warfarin Patient Self-Monitoring

NCT00925028 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2010-03-08

No results posted yet for this study

Summary

Atrial Fibrillation is a heart condition in which people are treated with blood thinners such as warfarin to decrease the risk of stroke. Large studies have shown that when patients adjust their own dose of warfarin, similar to insulin, results are better.

The purpose of this study is to evaluate whether implementing this method of warfarin management is beneficial in a Canadian primary care clinic. Patients will be educated on how to adjust their own warfarin doses when necessary using simple charts. The success of patient self management will be compared against management by a physician.

Conditions

Interventions

DRUG

Warfarin

Patients of group A will have the task of managing their own warfarin therapy using the provided nomograms. In the second office visit patients will be told to which group they were randomized and if they are in group A they will then be instructed on how to use the warfarin adjustment nomograms provided. After four months the groups will switch to the alternate management strategy. Patients in both groups will use warfarin tablets of two dosage strengths, 1 mg and 5 mg. All INR testing will be done at the community laboratory and results will be made available to the patient for dosage adjustment, as well as the physician. The physician's office will be available for appointments and phone calls from study subjects to discuss and support the process at any time.

DRUG

Warfarin

Patients of group B will continue to be managed by their physician. This time those in group B will be instructed on how to use the nomograms during an office visit. Patients in both groups will use warfarin tablets of two dosage strengths, 1 mg and 5 mg. All INR testing will be done at the community laboratory and results will be made available to the patient for dosage adjustment, as well as the physician. The physician's office will be available for appointments and phone calls from study subjects to discuss and support the process at any time.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Lori Laughland, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00925028 on ClinicalTrials.gov