Randomized Trial of Interventions to Improve Warfarin Adherence

Brief Title

Randomized Trial of Interventions to Improve Warfarin Adherence

Official Title

Randomized Trial of Interventions to Improve Warfarin Adherence

Brief Summary

      The purpose of this research study is to see if a lottery which provides the opportunity to
      win money, a reminder system using a "Med-eMonitor", or the combination of both might be
      useful in helping patients to achieve better control of their anticoagulation therapy.
      Selection for the arms of the study is randomized by the study computer. Some will
      participate in the daily lottery only, some with the reminder system only, some with the
      reminder system and the daily lottery, and some with neither the lottery nor the reminder
      system.
    

Detailed Description

      Eligible subjects will be enrolled in one of the 4 arms of the RCT and followed for 6 months,
      with the primary outcome of out-of-range INRs. Subjects will be given a Med-eMonitor to
      connect to their home phone line. For all subjects, these will be used to measure daily
      adherence. Subjects in the incentive group will be eligible for a daily lottery prize only
      if, prior to the lottery being resolved, their adherence device has registered adherence to
      their prescribed warfarin regimen. Subjects in the MM group will have the reminder/feedback
      features of the Med-eMonitor turned on to provide reminders to take their warfarin as
      prescribed and standardized messages that will be used to provide feedback in response to
      their adherence. Subjects in the combined group will be exposed to both the lottery and the
      activated Med-eMonitor. This trial is a randomized controlled trial.

      Both men and women who are at least 18 years of age and have been prescribed anticoagulation
      medication are eligible to participate.
    

Study Type

Interventional

Primary Outcome

Improved Warfarin Adherence/% Timeout of Target INR Range

Condition

Atrial Fibrillation

Intervention

Financial Incentive and Med-eMonitor

Study Arms / Comparison Groups

 1 Usual Care Group/Control

Description:  Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Behavioral

Estimated Enrollment

268

Start Date

October 2009

Completion Date

December 2013

Primary Completion Date

May 2012

Eligibility Criteria

        Key Inclusion Criteria

        The study population will include all patients at the study sites who:

          1. are in the maintenance phase of their warfarin treatment (defined using the standard
             method as the period of time following 2 consecutive visits, at least 7 days apart, of
             stable target INR after initiation of the drug)

          2. whose providers indicate are expected to stay on treatment for at least 6 months

          3. have a target INR of 2 to 3.5

          4. had at least one INR out of the participant's target range within 90 days prior to
             enrollment (excluding the baseline visit) and/or INR at the baseline visit was below
             the participant's target range

          5. have a working analog telephone line.

        Of note, patients do not have to be within their target INR range to enroll; we
        specifically want to include those who are below the target range at the time of study
        entry because they may be the patients most likely to be non-adherent.

        Key Exclusion Criteria Patients will be excluded if they do not meet the above inclusion
        criteria,

          1. have an INR at screening above the target range

          2. are less than 18 years of age and cannot or will not give consent

          3. cannot read above a 6th grade reading level

          4. are enrolled in a clinical trial of warfarin therapy

          5. are unable to adequately follow study procedures
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kevin Volpp, M.D., Ph.D., , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00904982

Organization ID

809166

Responsible Party

Sponsor

Study Sponsor

University of Pennsylvania

Study Sponsor

Kevin Volpp, M.D., Ph.D., Principal Investigator, University of Pennsylvania

Verification Date

January 2017