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

Sponsor

Montreal Heart Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01033279

Collaborator

Roche Diagnostic Ltd. (Industry)

120

Enrollment

Location

Arms

Duration (Months)

17.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulants Quality of Life Drug Monitoring Pharmacy Ambulatory Care	Other: Self-monitoring and adjustment of oral anticoagulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

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: warfarin coumadin coaguchek XS coaguchek

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:

warfarin

coumadin

coaguchek XS

coaguchek

Outcome Measures

Primary Outcome Measures

Anticoagulation-related quality of life [Four months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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