Testing Strategies to Improving Warfarin Adherence

December 1, 2009 updated by: University of Pennsylvania
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania Anticoagulation Management Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Other: 2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
anticoagulation control
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
adherence
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Aetna, Inc.

Investigators

  • Principal Investigator: Kevin G Volpp, M.D., Ph.D., University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

December 2, 2009

Last Update Submitted That Met QC Criteria

December 1, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 806634

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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