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OpenTrials
Completed

NCT Number: NCT00622102

Testing Strategies to Improving Warfarin Adherence

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deep Venous Thrombosis Dilated Cardiomyopathies Embolism and Thrombosis Genetic Diseases, Inborn Heart Diseases Laminopathies Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases Venous Thrombosis

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania Anticoagulation Management Center

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lottery arm (Lottery and Med-eMonitor)

Behavioral

Lottery and Med-eMonitor

Non-Lottery (Med-eMonitor only)

Behavioral

Med-eMonitor only

Primary outcomes

  1. anticoagulation control

    Time frame: six months

Secondary outcomes

  1. adherence

    Time frame: six months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Aetna, Inc.

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 22, 2008
Registry last updated
Dec 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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