Testing Strategies to Improving Warfarin Adherence

University of Pennsylvania

Status: Completed

Conditions: Atrial Fibrillation; Deep Venous Thrombosis; Dilated Cardiomyopathies

Treatments: Behavioral: Non-Lottery (Med-eMonitor only); Behavioral: Lottery arm (Lottery and Med-eMonitor)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00622102

806634

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

1

Experimental group

Description:

50% of the consenting subjects will take part in the lottery and use the Med-eMonitor as a device to monitor adherence

Treatment:

Behavioral: Lottery arm (Lottery and Med-eMonitor)

2

Other group

Description:

50% of the consenting subjects will use only the Med-eMonitor as a device to monitor adherence

Treatment:

Behavioral: Non-Lottery (Med-eMonitor only)