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
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

Additional relevant MeSH terms:
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014