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

This study has been completed.
Sponsor:
Collaborator:
Roche Diagnostic Ltd.
Information provided by (Responsible Party):
Lucie Verret, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT01033279
First received: December 15, 2009
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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 Intervention
Anticoagulants
Quality of Life
Drug Monitoring
Pharmacy
Ambulatory Care
Other: Self-monitoring and adjustment of oral anticoagulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluation of Self-monitoring of Oral antiCoagulant therApy by the PatiEnts

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • Anticoagulation-related quality of life [ Time Frame: Four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time in therapeutic International Normalized Ratio (INR) [ Time Frame: Four months ] [ Designated as safety issue: No ]
  • Time in extended therapeutic INR range [ Time Frame: Four months ] [ Designated as safety issue: No ]
  • Time in extreme INR ranges (<1.5 and > 5) [ Time Frame: Four months ] [ Designated as safety issue: Yes ]
  • Evolution of anticoagulation-related knowledge post training program [ Time Frame: Four months ] [ Designated as safety issue: No ]
  • Time spent by patients managing their oral anticoagulation [ Time Frame: Four months ] [ Designated as safety issue: No ]
  • Hemorrhagic events [ Time Frame: Four months ] [ Designated as safety issue: Yes ]
  • Thromboembolic events [ Time Frame: Four months ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033279

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

No publications provided by Montreal Heart Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lucie Verret, Chief Department of Pharmacy, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01033279     History of Changes
Other Study ID Numbers: 09-1158
Study First Received: December 15, 2009
Last Updated: May 29, 2012
Health Authority: Canada: Health Canada

Keywords provided by Montreal Heart Institute:
Coaguchek
Portable coagulometer
Self-monitoring
Coumadin
Warfarin
Quality of life
Pharmacist

ClinicalTrials.gov processed this record on October 23, 2014