Brief Title
Testing Strategies to Improving Warfarin Adherence
Official Title
Testing Strategies to Improving Warfarin Adherence
Brief Summary
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.
Study Type
Interventional
Primary Outcome
anticoagulation control
Secondary Outcome
adherence
Condition
Atrial Fibrillation
Intervention
Lottery arm (Lottery and Med-eMonitor)
Study Arms / Comparison Groups
1
Description: 50% of the consenting subjects will take part in the lottery and use the Med-eMonitor as a device to monitor adherence
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
101
Start Date
December 2007
Completion Date
April 2009
Primary Completion Date
April 2009
Eligibility Criteria
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
Gender
All
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Kevin G Volpp, M.D., Ph.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00622102
Organization ID
806634
Study Sponsor
University of Pennsylvania
Collaborators
Aetna, Inc.
Study Sponsor
Kevin G Volpp, M.D., Ph.D., Principal Investigator, University of Pennsylvania
Verification Date
December 2009