Testing Strategies to Improving Warfarin Adherence

Study Overview
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Brief Summary
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We are performing a research study to learn more about the control of an individual's blood thinning (anticoagulation) on warfarin. Individuals from an anticoagulation clinic are being asked to participate in order to see if a lottery which provides the opportunity to win money in combination with the use of the Med-eMonitor might be useful in helping patients to achieve better control of their anticoagulation therapy. Half of the participants will be enrolled in the lottery arm and the other half will be a control group who will receive the Med-eMonitor only.

Official Title
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Testing Strategies to Improving Warfarin Adherence

Conditions
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Atrial Fibrillation, Deep Venous Thrombosis, Dilated Cardiomyopathies

Intervention / Treatment
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* Behavioral: Lottery arm (Lottery and Med-eMonitor)
* Behavioral: Non-Lottery (Med-eMonitor only)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years old age or older On warfarin managed at the AC clinic Target INR 2.0-3.0 or 2.5-3.5 At maintenance phase of therapy (defined as stable INR with stable warfarin dosing over at least 2 consecutive visits) Exclusion Criteria: Do not have access to telephone line Unwillingness to participate or to sign a consent form(refusal) Inability to participate because of advances dementia, advanced Alzheimer's disease or other impairment affecting ability to provide informed consent and/or quality data or utilize the Med-eMonitor Participation in a current study that does not permit participation in another study End stage or terminal illness with anticipated life expectancy of 6 months or less INR over the upper limit for the individual's range at the time of enrollment (e.g.,>3.0 or >3.5, depending on the target range) Diagnosed with antiphospholipid antibody syndrome or abnormal INR prior to starting warfarin

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>50% of the consenting subjects will take part in the lottery and use the Med-eMonitor as a device to monitor adherence | Behavioral: Lottery arm (Lottery and Med-eMonitor)<br>* Lottery and Med-eMonitor<br>|
| Other: 2<br>50% of the consenting subjects will use only the Med-eMonitor as a device to monitor adherence | Behavioral: Non-Lottery (Med-eMonitor only)<br>* Med-eMonitor only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anticoagulation control |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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warfarin, adherence, Mechanical heart valves