Back to resultsTesting Strategies to Improving Warfarin Adherence
Primary Purpose
Atrial Fibrillation, Deep Venous Thrombosis, Dilated Cardiomyopathies
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lottery arm (Lottery and Med-eMonitor)
Non-Lottery (Med-eMonitor only)
Sponsored by
About this trial
This is an interventional health services research trial for Atrial Fibrillation focused on measuring warfarin, adherence, Mechanical heart valves
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
Sites / Locations
- Hospital of the University of Pennsylvania Anticoagulation Management Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
50% of the consenting subjects will take part in the lottery and use the Med-eMonitor as a device to monitor adherence
50% of the consenting subjects will use only the Med-eMonitor as a device to monitor adherence
Outcomes
Primary Outcome Measures
anticoagulation control
Secondary Outcome Measures
adherence
Full Information
NCT ID
NCT00622102
First Posted
January 15, 2008
Last Updated
December 1, 2009
Sponsor
University of Pennsylvania
Collaborators
Aetna, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00622102
Brief Title
Testing Strategies to Improving Warfarin Adherence
Official Title
Testing Strategies to Improving Warfarin Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pennsylvania
Collaborators
Aetna, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Deep Venous Thrombosis, Dilated Cardiomyopathies
Keywords
warfarin, adherence, Mechanical heart valves
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
50% of the consenting subjects will take part in the lottery and use the Med-eMonitor as a device to monitor adherence
Arm Title
2
Arm Type
Other
Arm Description
50% of the consenting subjects will use only the Med-eMonitor as a device to monitor adherence
Intervention Type
Behavioral
Intervention Name(s)
Lottery arm (Lottery and Med-eMonitor)
Intervention Description
Lottery and Med-eMonitor
Intervention Type
Behavioral
Intervention Name(s)
Non-Lottery (Med-eMonitor only)
Intervention Description
Med-eMonitor only
Primary Outcome Measure Information:
Title
anticoagulation control
Time Frame
six months
Secondary Outcome Measure Information:
Title
adherence
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin G Volpp, M.D., Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania Anticoagulation Management Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Testing Strategies to Improving Warfarin Adherence
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