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Testing Strategies to Improving Warfarin Adherence

Testing Strategies to Improving Warfarin Adherence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00622102
Enrollment
101
Registered
2008-02-22
Start date
2007-12-31
Completion date
2009-04-30
Last updated
2009-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Deep Venous Thrombosis, Dilated Cardiomyopathies

Keywords

warfarin, adherence, Mechanical heart valves

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.

Interventions

BEHAVIORALLottery arm (Lottery and Med-eMonitor)

Lottery and Med-eMonitor

BEHAVIORALNon-Lottery (Med-eMonitor only)

Med-eMonitor only

Sponsors

Aetna, Inc.
CollaboratorINDUSTRY
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
anticoagulation controlsix months

Secondary

MeasureTime frame
adherencesix months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026