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Completed

NCT Number: NCT01033279

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-monitoring and adjustment of oral anticoagulation

Other

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 outcomes

  1. Anticoagulation-related quality of life

    Time frame: Four months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

  • Roche Diagnostic Ltd.

Registry information

Official study title

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

Acronym: ESCAPE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 16, 2009
Registry last updated
May 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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