Testing Strategies to Improving Warfarin Adherence

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Deep Venous Thrombosis; Dilated Cardiomyopathies
• Interventions: Behavioral: Lottery arm (Lottery and Med-eMonitor); Behavioral: Non-Lottery (Med-eMonitor only)

• Registration Number: NCT00622102
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-01
• Last Update Posted: 2009-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lottery arm (Lottery and Med-eMonitor)	50% of the consenting subjects will take part in the lottery and use the Med-eMonitor as a device to monitor adherence
2	Non-Lottery (Med-eMonitor only)	50% of the consenting subjects will use only the Med-eMonitor as a device to monitor adherence

Primary Outcome Measures

Name	Time	Method
anticoagulation control	six months

Secondary Outcome Measures

Name	Time	Method
adherence	six months

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania Anticoagulation Management Center; 🇺🇸 Philadelphia, Pennsylvania, United States