Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 51 of 293 for:    warfarin AND anticoagulation

Testing Strategies to Improving Warfarin Adherence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00622102
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : December 2, 2009
Sponsor:
Collaborator:
Aetna, Inc.
Information provided by:
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE January 15, 2008
First Posted Date  ICMJE February 22, 2008
Last Update Posted Date December 2, 2009
Study Start Date  ICMJE December 2007
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2009)
anticoagulation control [ Time Frame: six months ]
Original Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: May 15, 2009)
adherence [ Time Frame: six months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testing Strategies to Improving Warfarin Adherence
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Atrial Fibrillation
  • Deep Venous Thrombosis
  • Dilated Cardiomyopathies
Intervention  ICMJE
  • Behavioral: Lottery arm (Lottery and Med-eMonitor)
    Lottery and Med-eMonitor
  • Behavioral: Non-Lottery (Med-eMonitor only)
    Med-eMonitor only
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2009)
101
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2008)
100
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00622102
Other Study ID Numbers  ICMJE 806634
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen E. Kimmel, M.D., M.S.C.E., University of Pennsylvania School of Medicine
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Aetna, Inc.
Investigators  ICMJE
Principal Investigator: Kevin G Volpp, M.D., Ph.D. University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP