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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-05-31

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.

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Detailed Description

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Conditions

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Anticoagulants Quality of Life Drug Monitoring Pharmacy Ambulatory Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual care

Patients followed by usual care at the hospital's anticoagulation clinic

Group Type NO_INTERVENTION

No interventions assigned to this group

Self-management

Self-monitoring and self-adjustment of oral anticoagulation according to predefined algorithms

Group Type EXPERIMENTAL

Self-monitoring and adjustment of oral anticoagulation

Intervention Type OTHER

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

Interventions

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Self-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

Intervention Type OTHER

Other Intervention Names

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warfarin coumadin coaguchek XS coaguchek

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No