Testing Strategies to Improving Warfarin Adherence

Atrial Fibrillation Clinical Trial

Official title:

Testing Strategies to Improving Warfarin Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622102
• Other study ID #: 806634
• Status: Completed
• Phase: N/A
• First received: January 15, 2008
• Last updated: December 1, 2009
• Start date: December 2007
• Est. completion date: April 2009

Study information

• Verified date: December 2009
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiomyopathies
• Cardiomyopathy, Dilated
• Deep Venous Thrombosis
• Dilated Cardiomyopathies
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania Anticoagulation Management Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Aetna, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anticoagulation control		six months	No
Secondary	adherence		six months	No