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Randomized Trial of Interventions to Improve Warfarin Adherence (WIN3)

Primary Purpose

Atrial Fibrillation, Deep Vein Thrombosis, Dilated Cardiomyopathies

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Financial Incentive and Med-eMonitor
2Med-eMonitor
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring warfarin, coumadin, adherence, mechanical heart valves

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of the University of Pennsylvania Anticoagulation Management Center
  • Philadelphia Veteran Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Experimental

Arm Label

1 Usual Care Group/Control

2Med-eMonitor/Reminder

3 Incentive Group/Lottery

4 Combined Group/Lottery and Reminder

Arm 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.

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 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.

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.

Outcomes

Primary Outcome Measures

Improved Warfarin Adherence/% Timeout of Target INR Range

Secondary Outcome Measures

Full Information

First Posted
May 18, 2009
Last Updated
January 27, 2017
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00904982
Brief Title
Randomized Trial of Interventions to Improve Warfarin Adherence
Acronym
WIN3
Official Title
Randomized Trial of Interventions to Improve Warfarin Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Deep Vein Thrombosis, Dilated Cardiomyopathies
Keywords
warfarin, coumadin, adherence, mechanical heart valves

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Usual Care Group/Control
Arm Type
Other
Arm 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.
Arm Title
2Med-eMonitor/Reminder
Arm Type
Experimental
Arm 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 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.
Arm Title
3 Incentive Group/Lottery
Arm Type
Experimental
Arm 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. 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.
Arm Title
4 Combined Group/Lottery and Reminder
Arm Type
Experimental
Arm 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 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.
Intervention Type
Behavioral
Intervention Name(s)
Financial Incentive and Med-eMonitor
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
2Med-eMonitor
Intervention Description
Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence.
Primary Outcome Measure Information:
Title
Improved Warfarin Adherence/% Timeout of Target INR Range
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin 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
Facility Name
Philadelphia Veteran Affairs Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27592594
Citation
Kimmel SE, Troxel AB, French B, Loewenstein G, Doshi JA, Hecht TE, Laskin M, Brensinger CM, Meussner C, Volpp K. A randomized trial of lottery-based incentives and reminders to improve warfarin adherence: the Warfarin Incentives (WIN2) Trial. Pharmacoepidemiol Drug Saf. 2016 Nov;25(11):1219-1227. doi: 10.1002/pds.4094. Epub 2016 Sep 4.
Results Reference
result
PubMed Identifier
22877814
Citation
Kimmel SE, Troxel AB, Loewenstein G, Brensinger CM, Jaskowiak J, Doshi JA, Laskin M, Volpp K. Randomized trial of lottery-based incentives to improve warfarin adherence. Am Heart J. 2012 Aug;164(2):268-74. doi: 10.1016/j.ahj.2012.05.005.
Results Reference
derived

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Randomized Trial of Interventions to Improve Warfarin Adherence

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