Testing Strategies to Improving Warfarin Adherence - Full Text View

Sponsor:	University of Pennsylvania
Collaborator:	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)

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Health Services Research
Official Title:	Testing Strategies to Improving Warfarin Adherence

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome DMD-associated dilated cardiomyopathy familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners Cardiomyopathy Deep Vein Thrombosis

Drug Information available for: Warfarin Warfarin sodium Warfarin potassium

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

anticoagulation control [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	101
Study Start Date:	December 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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

Locations

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.

Investigators

Principal Investigator:

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

University of Pennsylvania

More Information

No publications provided

Responsible Party:	Stephen E. Kimmel, M.D., M.S.C.E., University of Pennsylvania School of Medicine
ClinicalTrials.gov Identifier:	NCT00622102 History of Changes
Other Study ID Numbers:	806634
Study First Received:	January 15, 2008
Last Updated:	December 1, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

warfarin
adherence
Mechanical heart valves

Additional relevant MeSH terms:

Atrial Fibrillation
Cardiomyopathy, Dilated
Thrombosis
Venous Thrombosis
Cardiomyopathies
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

Cardiomegaly
Embolism and Thrombosis
Vascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 21, 2012