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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Anticoagulants; Drug Monitoring; Pharmacy; Ambulatory Care
• Intervention / Treatment: Other: Self-monitoring and adjustment of oral anticoagulation

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Patients followed by usual care at the hospital's anticoagulation clinic
Experimental: Self-management; Self-monitoring and self-adjustment of oral anticoagulation according to predefined algorithms	Other: 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; Other Names: coumadin; warfarin; coaguchek XS; coaguchek

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Collaborators: Roche Diagnostic Ltd.
• Investigators: Principal Investigator: Lucie Verret, B.Pharm, MSc, Montreal Heart Institute

Publications and helpful links

General Publications

• 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. Erratum In: Pharmacotherapy. 2013 Apr;33(4):464.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: December 15, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Estimate): May 30, 2012
• Last Update Submitted That Met QC Criteria: May 29, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Quality of life; Warfarin; Pharmacist; Self-monitoring; Coaguchek; Portable coagulometer; Coumadin
• Additional Relevant MeSH Terms: Anticoagulants; Warfarin
• Other Study ID Numbers: 09-1158

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No