Randomized Trial of Interventions to Improve Warfarin Adherence
- Conditions
- Atrial FibrillationDeep Vein ThrombosisDilated Cardiomyopathies
- Interventions
- Device: 2Med-eMonitorBehavioral: Financial Incentive and Med-eMonitor
- Registration Number
- NCT00904982
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
The purpose of this research study is to see if a lottery which provides the opportunity to win money, a reminder system using a "Med-eMonitor", or the combination of both might be useful in helping patients to achieve better control of their anticoagulation therapy. Selection for the arms of the study is randomized by the study computer. Some will participate in the daily lottery only, some with the reminder system only, some with the reminder system and the daily lottery, and some with neither the lottery nor the reminder system.
- Detailed Description
Eligible subjects will be enrolled in one of the 4 arms of the RCT and followed for 6 months, with the primary outcome of out-of-range INRs. Subjects will be given a Med-eMonitor to connect to their home phone line. For all subjects, these will be used to measure daily adherence. Subjects in the incentive group will be eligible for a daily lottery prize only if, prior to the lottery being resolved, their adherence device has registered adherence to their prescribed warfarin regimen. Subjects in the MM group will have the reminder/feedback features of the Med-eMonitor turned on to provide reminders to take their warfarin as prescribed and standardized messages that will be used to provide feedback in response to their adherence. Subjects in the combined group will be exposed to both the lottery and the activated Med-eMonitor. This trial is a randomized controlled trial.
Both men and women who are at least 18 years of age and have been prescribed anticoagulation medication are eligible to participate.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 268
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2Med-eMonitor/Reminder 2Med-eMonitor 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. 1 Usual Care Group/Control Financial Incentive and Med-eMonitor 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. 3 Incentive Group/Lottery Financial Incentive and Med-eMonitor 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. 4 Combined Group/Lottery and Reminder Financial Incentive and Med-eMonitor 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.
- Primary Outcome Measures
Name Time Method Improved Warfarin Adherence/% Timeout of Target INR Range six months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Philadelphia Veteran Affairs Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania Anticoagulation Management Center
🇺🇸Philadelphia, Pennsylvania, United States