Randomized Trial of Interventions to Improve Warfarin Adherence (WIN3)
Atrial Fibrillation, Deep Vein Thrombosis, Dilated Cardiomyopathies
About this trial
This is an interventional other trial for Atrial Fibrillation focused on measuring warfarin, coumadin, adherence, mechanical heart valves
Eligibility Criteria
Key Inclusion Criteria
The study population will include all patients at the study sites who:
- are in the maintenance phase of their warfarin treatment (defined using the standard method as the period of time following 2 consecutive visits, at least 7 days apart, of stable target INR after initiation of the drug)
- whose providers indicate are expected to stay on treatment for at least 6 months
- have a target INR of 2 to 3.5
- had at least one INR out of the participant's target range within 90 days prior to enrollment (excluding the baseline visit) and/or INR at the baseline visit was below the participant's target range
- have a working analog telephone line.
Of note, patients do not have to be within their target INR range to enroll; we specifically want to include those who are below the target range at the time of study entry because they may be the patients most likely to be non-adherent.
Key Exclusion Criteria Patients will be excluded if they do not meet the above inclusion criteria,
- have an INR at screening above the target range
- are less than 18 years of age and cannot or will not give consent
- cannot read above a 6th grade reading level
- are enrolled in a clinical trial of warfarin therapy
- are unable to adequately follow study procedures
Sites / Locations
- Hospital of the University of Pennsylvania Anticoagulation Management Center
- Philadelphia Veteran Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Experimental
Experimental
Experimental
1 Usual Care Group/Control
2Med-eMonitor/Reminder
3 Incentive Group/Lottery
4 Combined Group/Lottery and Reminder
Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.
Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.
Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.
Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.