Testing Strategies to Improving Warfarin Adherence

• ClinicalTrials.gov Identifier: NCT00622102
• Recruitment Status: Completed
• First Posted: February 22, 2008
• Last Update Posted: December 2, 2009
• Sponsor: University of Pennsylvania
• Collaborator: Aetna, Inc.
• Information provided by: University of Pennsylvania

Tracking Information

• First Submitted Date: January 15, 2008
• First Posted Date: February 22, 2008
• Last Update Posted Date: December 2, 2009
• Study Start Date: December 2007
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 15, 2009): anticoagulation control [ Time Frame: six months ]
• Original Primary Outcome Measures (submitted: February 21, 2008): improved warfarin adherence [ Time Frame: six months ]
• Change History: Complete list of historical versions of study NCT00622102 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: May 15, 2009): adherence [ Time Frame: six months ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Testing Strategies to Improving Warfarin Adherence
• Official Title: Testing Strategies to Improving Warfarin Adherence
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Health Services Research

Condition

• Atrial Fibrillation
• Deep Venous Thrombosis
• Dilated Cardiomyopathies

Intervention

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

Study Arms

• Experimental: 1
  50% of the consenting subjects will take part in the lottery and use the Med-eMonitor as a device to monitor adherence
  Intervention: Behavioral: Lottery arm (Lottery and Med-eMonitor)
• 2
  50% of the consenting subjects will use only the Med-eMonitor as a device to monitor adherence
  Intervention: Behavioral: Non-Lottery (Med-eMonitor only)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 1, 2009): 101
• Original Estimated Enrollment (submitted: February 21, 2008): 100
• Actual Study Completion Date: April 2009
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00622102
• Other Study ID Numbers: 806634
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Stephen E. Kimmel, M.D., M.S.C.E., University of Pennsylvania School of Medicine
• Study Sponsor: University of Pennsylvania
• Collaborators: Aetna, Inc.

Investigators

• Principal Investigator: Kevin G Volpp, M.D., Ph.D.; University of Pennsylvania

• PRS Account: University of Pennsylvania
• Verification Date: December 2009