Testing Strategies to Improving Warfarin Adherence - Full Text View

Sponsors and Collaborators:	University of Pennsylvania Aetna, Inc.
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00622102

Purpose

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	Intervention
Atrial Fibrillation Deep Venous Thrombosis Dilated Cardiomyopathies	Behavioral: Lottery arm (Lottery and Med-eMonitor) Behavioral: Non-Lottery (Med-eMonitor only)

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Blood Thinners Cardiomyopathy Deep Vein Thrombosis

Drug Information available for: Warfarin Warfarin potassium Warfarin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind (Investigator), Parallel Assignment
Official Title:	Testing Strategies to Improving Warfarin Adherence

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

improved warfarin adherence [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	December 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
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

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622102

Contacts

Contact: Jane A Jaskowiak, B.S.N., R.N.

215-898-2625

janejask@mail.med.upenn.edu

Locations

United States, Pennsylvania
Hospital of the University of Pennsylvania Anticoagulation Management Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Kevin G Volpp, M.D., Ph.D.

Sponsors and Collaborators

University of Pennsylvania

Aetna, Inc.

Investigators

Principal Investigator:

Kevin G Volpp, M.D., Ph.D.

University of Pennsylvania

More Information

Responsible Party:	University of Pennsylvania School of Medicine ( Stephen E. Kimmel, M.D., M.S.C.E. )
Study ID Numbers:	806634
Study First Received:	January 15, 2008
Last Updated:	February 21, 2008
ClinicalTrials.gov Identifier:	NCT00622102
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

warfarin
adherence
Mechanical heart valves

Study placed in the following topic categories:

Heart Diseases
Cardiomyopathy, Dilated
Vascular Diseases
Warfarin
Cardiomyopathies
Thrombosis
Embolism and Thrombosis

Embolism
Venous Thrombosis
Atrial Fibrillation
Cardiomegaly
Dilated cardiomyopathy
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Anticoagulants
Pathologic Processes
Therapeutic Uses

Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009