Warfarin Patient Self-Monitoring

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00925028
First received: June 17, 2009
Last updated: March 4, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Drug: Warfarin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: THE FEASIBILITY OF PATIENT SELF-MANAGEMENT OF WARFARIN THERAPY IN THE CANADIAN PRIMARY CARE SETTING

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Proportion of INR values which are in therapeutic range [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satisfaction of PSM vs. physician-management of anticoagulation as measured by a questionnaire [ Designated as safety issue: No ]
  • Additional office visits and phone calls pertaining to anticoagulation [ Designated as safety issue: No ]
  • Complications including thromboembolic events including stroke, myocardial infarction, deep vein thrombosis, pulmonary embolism, arterial thrombosis, and major and minor hemorrhages [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: July 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Patients of group A will have the task of managing their own warfarin therapy using the provided nomograms. After four months the groups will switch to the alternate management strategy.
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.
Experimental: Group B
Patients of group B will continue to be managed by their physician. After four months the groups will switch to the alternate management strategy.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Over 18 years of age
  • Anticoagulation to a target of 2.0-3.0
  • Warfarin treatment for > 3 months
  • previous medication treatment adherence
  • competence judged by demonstrable ability to utilize drug adjustment nomograms
  • understand the basic theory of anticoagulation therapy

Exclusion Criteria:

  • Coagulopathic disease
  • significant psychiatric illness
  • significant language barrier
  • poor visual acuity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925028

Locations
Canada, British Columbia
Gaetz Family Practice
Chilliwack, British Columbia, Canada, V2R 3P1
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Lori Laughland, MD University of British Columbia
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lori Laughland, University of British Columbia
ClinicalTrials.gov Identifier: NCT00925028     History of Changes
Other Study ID Numbers: H09-00754
Study First Received: June 17, 2009
Last Updated: March 4, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014