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

U

University of Montreal

Status

Completed

Conditions

Drug Monitoring
Quality of Life
Anticoagulants
Ambulatory Care
Pharmacy

Treatments

Other: Self-monitoring and adjustment of oral anticoagulation

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01033279
09-1158

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Usual care
No Intervention group
Description:
Patients followed by usual care at the hospital's anticoagulation clinic
Self-management
Experimental group
Description:
Self-monitoring and self-adjustment of oral anticoagulation according to predefined algorithms
Treatment:
Other: Self-monitoring and adjustment of oral anticoagulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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