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Clinical Trials/NCT00622102
NCT00622102CompletedNot Applicable

Testing Strategies to Improving Warfarin Adherence

University of Pennsylvania2 sites in 1 country101 target enrollmentStarted: December 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
101
Locations
2
Primary Endpoint
anticoagulation control
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Investigator)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

anticoagulation control

Time Frame: six months

Secondary Outcomes

  • adherence(six months)

Investigators

Sponsor Class
Other

Study Sites (2)

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Testing Strategies to Improving Warfarin... | Clinical Trial