Quality of Life and Efficacy Evaluation of Patient Self-monitoring Their Oral Anticoagulation Therapy (ESCAPE)
This study has been completed.
Sponsor:
Montreal Heart Institute
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
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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:
|
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 May 23, 2013