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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Self-monitoring of Oral antiCoagulant therApy by the PatiEnts

Conditions
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Anticoagulants, Quality of Life, Drug Monitoring, Pharmacy, Ambulatory Care

Intervention / Treatment
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* Other: Self-monitoring and adjustment of oral anticoagulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Patients followed by usual care at the hospital's anticoagulation clinic | |
| Experimental: Self-management<br>Self-monitoring and self-adjustment of oral anticoagulation according to predefined algorithms | Other: Self-monitoring and adjustment of oral anticoagulation<br>* 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<br>* Other names: coaguchek;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticoagulation-related quality of life |  | Four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coaguchek, Portable coagulometer, Self-monitoring, Coumadin, Warfarin, Quality of life, Pharmacist