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Trial record 47 of 293 for:    warfarin AND anticoagulation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01033279
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : May 30, 2012
Roche Diagnostic Ltd.
Information provided by (Responsible Party):
Lucie Verret, Montreal Heart Institute

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : October 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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

Primary Outcome Measures :
  1. Anticoagulation-related quality of life [ Time Frame: Four months ]

Secondary Outcome Measures :
  1. Time in therapeutic International Normalized Ratio (INR) [ Time Frame: Four months ]
  2. Time in extended therapeutic INR range [ Time Frame: Four months ]
  3. Time in extreme INR ranges (<1.5 and > 5) [ Time Frame: Four months ]
  4. Evolution of anticoagulation-related knowledge post training program [ Time Frame: Four months ]
  5. Time spent by patients managing their oral anticoagulation [ Time Frame: Four months ]
  6. Hemorrhagic events [ Time Frame: Four months ]
  7. Thromboembolic events [ Time Frame: Four months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01033279

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Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
Roche Diagnostic Ltd.
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Principal Investigator: Lucie Verret, B.Pharm, MSc Montreal Heart Institute

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lucie Verret, Chief Department of Pharmacy, Montreal Heart Institute Identifier: NCT01033279     History of Changes
Other Study ID Numbers: 09-1158
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012
Keywords provided by Lucie Verret, Montreal Heart Institute:
Portable coagulometer
Quality of life
Additional relevant MeSH terms:
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