Quality of Life and Efficacy Evaluation of Patient Self-monitoring Their Oral Anticoagulation Therapy

Not Applicable

Completed

• Conditions: Pharmacy; Ambulatory Care; Anticoagulants; Quality of Life; Drug Monitoring
• Interventions: Other: Self-monitoring and adjustment of oral anticoagulation

• Registration Number: NCT01033279
• Lead Sponsor: Montreal Heart Institute

Brief Summary

The purpose of this study is to determine whether self-management of oral anticoagulation therapy with warfarin has an effect on patient's quality of life following a specific training program led by pharmacists.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-29
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patient aged 18 years and over followed at the Montreal Heart Institute's Anticoagulation clinic
• Warfarin treatment planned for at least 4 months after inclusion in the study
• Warfarin treatment initiated for at least 6 months
• Last 2 INRs between 1.5 and 4 if target INR is between 2 and 3
• Last 2 INRS between 2 and 4 if target INR is between 2.5 and 3.5
• Provide a signed informed consent

Exclusion Criteria

• Patient unable to understand (spoken and written) French or English
• Patient refuses or is unable to attend the required training sessions
• Targeted INR other than 2 to 3 or 2.5 to 3.5
• Handicap or physical limitation compromising the patient's ability to initiate self-monitoring in the absence of a proxy helper
• Moderate to severe cognitive impairment or important comprehension problems
• Active neoplasm
• Concurrent chemotherapy
• Hypercoagulable conditions
• Life expectancy of less than 1 year documented in the medical chart
• Inclusion (at time of inclusion or 30 days prior to inclusion) in another research project involving a drug
• Patient anticoagulated with nicoumalone
• Pregnancy or breastfeeding
• Active bleeding (except for menses)
• Recent major bleeding (less than 3 months before inclusion)
• Stroke, acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft, cardiac valve replacement, deep veinous thrombosis or pulmonary embolism in the 3 months prior to inclusion
• Any other condition that, in the opinion of the investigators, of the treating physician or of the healthcare professionals working at the anticoagulation clinic could make self-management by the patient impossible

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-management	Self-monitoring and adjustment of oral anticoagulation	Self-monitoring and self-adjustment of oral anticoagulation according to predefined algorithms

Primary Outcome Measures

Name	Time	Method
Anticoagulation-related quality of life	Four months

Secondary Outcome Measures

Name	Time	Method
Time in therapeutic International Normalized Ratio (INR)	Four months
Time in extended therapeutic INR range	Four months
Time in extreme INR ranges (<1.5 and > 5)	Four months
Evolution of anticoagulation-related knowledge post training program	Four months
Time spent by patients managing their oral anticoagulation	Four months
Hemorrhagic events	Four months
Thromboembolic events	Four months

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada