AnticoagulantsESCAPENCT01033279
Quality of Life and Efficacy Evaluation of Patient Self-monitoring Their Oral Anticoagulation Therapy
A study testing Self-monitoring and adjustment of oral anticoagulation in people with Anticoagulants and Quality of Life, run by Montreal Heart Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anticoagulants, Quality of Life, Drug Monitoring
- What is being tested?
- Self-monitoring and adjustment of oral anticoagulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Self-monitoring of Oral antiCoagulant therApy by the PatiEnts
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.
- Conditions
- Anticoagulants, Quality of Life, Drug Monitoring, Pharmacy, Ambulatory Care
- Being tested
- Self-monitoring and adjustment of oral anticoagulation
- Keywords
- Coaguchek, Portable coagulometer, Self-monitoring, Coumadin, Warfarin, Quality of life, Pharmacist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-monitoring and adjustment of oral anticoagulationOther
Also called warfarin, coumadin, coaguchek XS, coaguchek
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Self-monitoring and adjustment of oral anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anticoagulation-related quality of life
Measured: Four months
Secondary outcomes (7)
Time in therapeutic International Normalized Ratio (INR)
Measured: Four months
Time in extended therapeutic INR range
Measured: Four months
Time in extreme INR ranges (<1.5 and > 5)
Measured: Four months
Evolution of anticoagulation-related knowledge post training program
Measured: Four months
Time spent by patients managing their oral anticoagulation
Measured: Four months
Hemorrhagic events
Measured: Four months
Thromboembolic events
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnticoagulantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostic Ltd.
- Responsible party
- Principal investigator, Lucie Verret, Montreal Heart Institute
- Investigators
- Lucie Verret, B.Pharm, MSc, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033279
- Sponsor's protocol ID
- 09-1158
- Acronym
- ESCAPE
- Status last verified
- May 2012
- First submitted
- 15 Dec 2009
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23033226
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Self-monitoring of Oral antiCoagulant therApy by the PatiEnts
- ClinicalTrials.gov ID
- NCT01033279
- Acronym / sponsor ID
- ESCAPE / 09-1158
- Conditions
- Anticoagulants, Quality of Life, Drug Monitoring, Pharmacy, Ambulatory Care
- Keywords
- Coaguchek, Portable coagulometer, Self-monitoring, Coumadin, Warfarin, Quality of life, Pharmacist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Roche Diagnostic Ltd.
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients followed by usual care at the hospital's anticoagulation clinic |
| Self-management | Experimental | Other: Self-monitoring and adjustment of oral anticoagulationSelf-monitoring and self-adjustment of oral anticoagulation according to predefined algorithms |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-monitoring and adjustment of oral anticoagulationAlso: warfarin, coumadin, coaguchek XS, coaguchekWeekly 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 | Self-management |
Primary outcome
Anticoagulation-related quality of life
Time frame: Four months
7 secondary outcomes
Time in therapeutic International Normalized Ratio (INR)
Time frame: Four months
Time in extended therapeutic INR range
Time frame: Four months
Time in extreme INR ranges (<1.5 and > 5)
Time frame: Four months
Evolution of anticoagulation-related knowledge post training program
Time frame: Four months
Time spent by patients managing their oral anticoagulation
Time frame: Four months
Hemorrhagic events
Time frame: Four months
Thromboembolic events
Time frame: Four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
- Derived from this study: PubMed 23033226Verret 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.
Related trials for Anticoagulants
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
Not yet recruitingObservational study
High-risk Antithrombotic Drugs at Discharge and Consultation for Hemorrhagic or Thromboembolic Events in the Emergency Department
Acute Disease
RecruitingPhase 3
Testing a New Treatment Strategy to Improve Secondary Stroke Prevention for Older Adults: The STROKE75+ Trial
Stroke, Ischemic
Not yet recruitingObservational study
Changes in the Etiology of Acute Limb Ischemia in the DOAK Era
Acute Limb Ischemia, Anticoagulants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucie Verret, B.Pharm, MSc principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-monitoring and adjustment of oral anticoagulation in people with Anticoagulants and Quality of Life, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anticoagulation-related quality of life (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01033279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2012.