Ambulatory Care, Anticoagulants, Drug Monitoring, Pharmacy, Quality of Life
Conditions
Keywords
Coaguchek, Portable coagulometer, Self-monitoring, Coumadin, Warfarin, Quality of life, Pharmacist
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.
Interventions
OTHERSelf-monitoring and adjustment of oral anticoagulation
Weekly self-monitoring of oral anticoagulation with a portable coagulometer and predefined adjustment algorithms for 4 months following a training program led and designed by hospital pharmacists
Sponsors
Roche Diagnostic Ltd.
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anticoagulation-related quality of life | Four months |
Secondary
| Measure | Time frame |
|---|---|
| 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 in therapeutic International Normalized Ratio (INR) | Four months |
| Hemorrhagic events | Four months |
| Thromboembolic events | Four months |
| Time spent by patients managing their oral anticoagulation | Four months |
Countries
Canada
Outcome results
None listed