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

Quality of Life Clinical Trial

— ESCAPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033279
• Other study ID #: 09-1158
• Status: Completed
• Phase: N/A
• First received: December 15, 2009
• Last updated: May 29, 2012
• Start date: October 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2012
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Ambulatory Care
• Anticoagulants
• Drug Monitoring
• Pharmacy
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Roche Diagnostic Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anticoagulation-related quality of life		Four months	No
Secondary	Time in therapeutic International Normalized Ratio (INR)		Four months	No
Secondary	Time in extended therapeutic INR range		Four months	No
Secondary	Time in extreme INR ranges (<1.5 and > 5)		Four months	Yes
Secondary	Evolution of anticoagulation-related knowledge post training program		Four months	No
Secondary	Time spent by patients managing their oral anticoagulation		Four months	No
Secondary	Hemorrhagic events		Four months	Yes
Secondary	Thromboembolic events		Four months	Yes