Randomized Trial of Interventions to Improve Warfarin Adherence - Full Text View

Sponsor:	University of Pennsylvania
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00904982

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation Deep Vein Thrombosis Dilated Cardiomyopathies	Behavioral: Financial Incentive and Med-eMonitor Device: 2Med-eMonitor	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator)
Official Title:	Randomized Trial of Interventions to Improve Warfarin Adherence

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners Cardiomyopathy Deep Vein Thrombosis

Drug Information available for: Warfarin Warfarin sodium Warfarin potassium

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Improved warfarin adherence [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment:	268
Study Start Date:	October 2009
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Usual Care Group 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.	Behavioral: Financial Incentive and Med-eMonitor Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly. Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she is taking his/her medication for the day. The device registers their answers and sends the compliance information via the participants' telephone line nightly to a central study server.
Experimental: 2Med-eMonitor 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 and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.	Device: 2Med-eMonitor Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence.
Experimental: 3 Incentive Group 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. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.	Behavioral: Financial Incentive and Med-eMonitor Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly. Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she is taking his/her medication for the day. The device registers their answers and sends the compliance information via the participants' telephone line nightly to a central study server.
Experimental: 4 Combined Group 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 and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.	Behavioral: Financial Incentive and Med-eMonitor Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly. Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she is taking his/her medication for the day. The device registers their answers and sends the compliance information via the participants' telephone line nightly to a central study server.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria

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

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)
whose providers indicate are expected to stay on treatment for at least 6 months
have a target INR of 2 to 3.5
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
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,

have an INR at screening above the target range
are less than 18 years of age and cannot or will not give consent
cannot read above a 6th grade reading level
are enrolled in a clinical trial of warfarin therapy
are unable to adequately follow study procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904982

Contacts

Contact: Christopher Meussner, BS	215-898-8188	meussner@upenn.edu
Contact: Sarah Windawi, MPH	215-573-9720	swindawi@mail.med.upenn.edu

Locations

United States, Pennsylvania
Hospital of the University of Pennsylvania Anticoagulation Management Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Christopher Meussner, BS 215-898-8188 meussner@mail.med.upenn.edu
Principal Investigator: Kevin Volpp, M.D., Ph.D.
Philadelphia Veteran Affairs Medical Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Christopher Meussner, BS 215-898-8188 meussner@upenn.edu
Contact: Kevin Volpp, M.D., Ph.D. volpp70@mail.med.upenn.edu
Principal Investigator: Kevin Volpp, M.D., Ph.D.

Sponsors and Collaborators

University of Pennsylvania

Investigators

Principal Investigator:

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

University of Pennsylvania

More Information

No publications provided

Responsible Party:	Kevin Volpp, M.D., Ph.D., University of Pennsylvania, School of Medicine
ClinicalTrials.gov Identifier:	NCT00904982 History of Changes
Other Study ID Numbers:	809166
Study First Received:	May 18, 2009
Last Updated:	August 4, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

warfarin
coumadin
adherence
mechanical heart valves

Additional relevant MeSH terms:

Atrial Fibrillation
Cardiomyopathy, Dilated
Thrombosis
Venous Thrombosis
Cardiomyopathies
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

Cardiomegaly
Embolism and Thrombosis
Vascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012