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

University of Montreal

Status: Completed

Conditions: Drug Monitoring; Quality of Life; Anticoagulants; Ambulatory Care; Pharmacy

Treatments: Other: Self-monitoring and adjustment of oral anticoagulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01033279

09-1158

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Usual care

No Intervention group

Description:

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

Self-management

Experimental group

Description:

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

Treatment:

Other: Self-monitoring and adjustment of oral anticoagulation