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Testing Strategies to Improving Warfarin Adherence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00622102
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : December 2, 2009
Aetna, Inc.
Information provided by:
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Deep Venous Thrombosis Dilated Cardiomyopathies Behavioral: Lottery arm (Lottery and Med-eMonitor) Behavioral: Non-Lottery (Med-eMonitor only) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Testing Strategies to Improving Warfarin Adherence
Study Start Date : December 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: 1
50% of the consenting subjects will take part in the lottery and use the Med-eMonitor as a device to monitor adherence
Behavioral: Lottery arm (Lottery and Med-eMonitor)
Lottery and Med-eMonitor

50% of the consenting subjects will use only the Med-eMonitor as a device to monitor adherence
Behavioral: Non-Lottery (Med-eMonitor only)
Med-eMonitor only

Primary Outcome Measures :
  1. anticoagulation control [ Time Frame: six months ]

Secondary Outcome Measures :
  1. adherence [ Time Frame: six months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00622102

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United States, Pennsylvania
Hospital of the University of Pennsylvania Anticoagulation Management Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Aetna, Inc.
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Principal Investigator: Kevin G Volpp, M.D., Ph.D. University of Pennsylvania
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Responsible Party: Stephen E. Kimmel, M.D., M.S.C.E., University of Pennsylvania School of Medicine Identifier: NCT00622102    
Other Study ID Numbers: 806634
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009
Keywords provided by University of Pennsylvania:
Mechanical heart valves
Additional relevant MeSH terms:
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Atrial Fibrillation
Venous Thrombosis
Cardiomyopathy, Dilated
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases