Atrial Fibrillation Clinical Trial
Official title:
Randomized Trial of Interventions to Improve Warfarin Adherence
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)
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