Status:
COMPLETED
Randomized Trial of Interventions to Improve Warfarin Adherence
Lead Sponsor:
University of Pennsylvania
Conditions:
Atrial Fibrillation
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
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 h...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT00904982
Start Date
October 1 2009
End Date
December 1 2013
Last Update
March 16 2017
Active Locations (2)
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1
Hospital of the University of Pennsylvania Anticoagulation Management Center
Philadelphia, Pennsylvania, United States, 19104
2
Philadelphia Veteran Affairs Medical Center
Philadelphia, Pennsylvania, United States, 19104