Warfarin Patient Self-Monitoring

NCT00925028 | Completed

• 1 other identifier: H09-00754
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Proportion of INR values which are in therapeutic range

Secondary Outcomes (3)

• Satisfaction of PSM vs. physician-management of anticoagulation as measured by a questionnaire

• Additional office visits and phone calls pertaining to anticoagulation

• Complications including thromboembolic events including stroke, myocardial infarction, deep vein thrombosis, pulmonary embolism, arterial thrombosis, and major and minor hemorrhages

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Interventions

Warfarin DRUG

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.

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Coagulopathic disease
• significant psychiatric illness
• significant language barrier
• poor visual acuity

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Gaetz Family Practice

Chilliwack, British Columbia, V2R 3P1, Canada

Location

Related Publications (1)

• Grunau BE, Wiens MO, Harder KK. Patient self-management of warfarin therapy: pragmatic feasibility study in Canadian primary care. Can Fam Physician. 2011 Aug;57(8):e292-8.

  PMID: 21841092 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Warfarin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lori Laughland, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 19, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 8, 2010

Record last verified: 2010-03

Locations

CA (1)