Testing Strategies to Improving Warfarin Adherence

NCT00622102 | Completed DMC

• 1 other identifier: 806634
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Deep Venous Thrombosis; Dilated Cardiomyopathies

Keywords

warfarin; adherence; Mechanical heart valves

Outcome Measures

Primary Outcomes (1)

• anticoagulation control

  six months

Secondary Outcomes (1)

• adherence

  six months

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Lottery arm (Lottery and Med-eMonitor)

2

OTHER

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

Behavioral: Non-Lottery (Med-eMonitor only)

Interventions

Lottery arm (Lottery and Med-eMonitor) BEHAVIORAL

Lottery and Med-eMonitor

1

Non-Lottery (Med-eMonitor only) BEHAVIORAL

Med-eMonitor only

2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Aetna, Inc.: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania Anticoagulation Management Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thrombosis; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kevin G Volpp, M.D., Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: February 22, 2008
• Study Start: December 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 2, 2009

Record last verified: 2009-12

Locations

US (1)