Testing Strategies to Improving Warfarin Adherence

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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