NCT01033279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

December 15, 2009

Last Update Submit

May 29, 2012

Conditions

AnticoagulantsQuality of LifeDrug MonitoringPharmacyAmbulatory Care

Keywords

CoaguchekPortable coagulometerSelf-monitoringCoumadinWarfarinQuality of lifePharmacist

Outcome Measures

Primary Outcomes (1)

  • Anticoagulation-related quality of life

    Four months

Secondary Outcomes (7)

  • Time in therapeutic International Normalized Ratio (INR)

    Four months

  • Time in extended therapeutic INR range

    Four months

  • Time in extreme INR ranges (<1.5 and > 5)

    Four months

  • Evolution of anticoagulation-related knowledge post training program

    Four months

  • Time spent by patients managing their oral anticoagulation

    Four months

  • +2 more secondary outcomes

Study Arms (2)

Usual care

NO INTERVENTION

Patients followed by usual care at the hospital's anticoagulation clinic

Self-management

EXPERIMENTAL

Self-monitoring and self-adjustment of oral anticoagulation according to predefined algorithms

Other: Self-monitoring and adjustment of oral anticoagulation

Interventions

Self-monitoring and adjustment of oral anticoagulationOTHER

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

Also known as: warfarin, coumadin, coaguchek XS, coaguchek
Self-management

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient aged 18 years and over followed at the Montreal Heart Institute's Anticoagulation clinic
  • 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

You may not qualify if:

  • 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
  • Patient anticoagulated with nicoumalone
  • Pregnancy or breastfeeding
  • Active bleeding (except for menses)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (1)

  • Verret L, Couturier J, Rozon A, Saudrais-Janecek S, St-Onge A, Nguyen A, Basmadjian A, Tremblay S, Brouillette D, de Denus S. Impact of a pharmacist-led warfarin self-management program on quality of life and anticoagulation control: a randomized trial. Pharmacotherapy. 2012 Oct;32(10):871-9. doi: 10.1002/j.1875-9114.2012.01116.

    PMID: 23033226DERIVED

MeSH Terms

Interventions

Warfarin

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Lucie Verret, B.Pharm, MSc

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Department of Pharmacy

Study Record Dates

First Submitted

December 15, 2009

First Posted

December 16, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

CA(1)