Clinical trial NCT01033279: Quality of Life and Efficacy Evaluation of Patient Self-monitoring Their Oral Anticoagulation Therapy
Official title: Evaluation of Self-monitoring of Oral antiCoagulant therApy by the PatiEnts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anticoagulants
Quality of Life
Drug Monitoring
Pharmacy
Ambulatory Care
Keywords: Coaguchek
Portable coagulometer
Self-monitoring
Coumadin
Warfarin
Quality of life
Pharmacist
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Roche Diagnostic Ltd.
First posted: 2009-12-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Anticoagulation-related quality of life
timeFrame: Four months
Secondary outcomes:
measure: Time in therapeutic International Normalized Ratio (INR)
timeFrame: Four months
measure: Time in extended therapeutic INR range
timeFrame: Four months
measure: Time in extreme INR ranges (<1.5 and > 5)
timeFrame: Four months
measure: Evolution of anticoagulation-related knowledge post training program
timeFrame: Four months
measure: Time spent by patients managing their oral anticoagulation
timeFrame: Four months
measure: Hemorrhagic events
timeFrame: Four months
measure: Thromboembolic events
timeFrame: Four months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Lucie Verret, B.Pharm, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verret L, Couturier J, Rozon A, Saudrais-Janecek S, St-Onge A, Nguyen A, Basmadjian A, Tremblay S, Brouillette D, de Denus S. Impact of a pharmacist-led warfarin self-management program on quality of life and anticoagulation control: a randomized trial. Pharmacotherapy. 2012 Oct;32(10):871-9. doi: 10.1002/j.1875-9114.2012.01116.