NCT00904982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

March 16, 2017

Completed
Last Updated

March 16, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

May 18, 2009

Results QC Date

January 6, 2017

Last Update Submit

January 27, 2017

Conditions

Atrial FibrillationDeep Vein ThrombosisDilated Cardiomyopathies

Keywords

warfarincoumadinadherencemechanical heart valves

Outcome Measures

Primary Outcomes (1)

  • Improved Warfarin Adherence/% Timeout of Target INR Range

    six months

Study Arms (4)

1 Usual Care Group/Control

OTHER

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

2Med-eMonitor/Reminder

EXPERIMENTAL

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

3 Incentive Group/Lottery

EXPERIMENTAL

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

4 Combined Group/Lottery and Reminder

EXPERIMENTAL

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

Interventions

Financial Incentive and Med-eMonitorBEHAVIORAL

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.

1 Usual Care Group/Control3 Incentive Group/Lottery4 Combined Group/Lottery and Reminder
2Med-eMonitorDEVICE

Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence.

2Med-eMonitor/Reminder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital of the University of Pennsylvania Anticoagulation Management Center

Philadelphia, Pennsylvania, 19104, United States

Location

Philadelphia Veteran Affairs Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

    PMID: 27592594RESULT

  • 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.

    PMID: 22877814DERIVED

MeSH Terms

Conditions

Atrial FibrillationVenous ThrombosisCardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsThrombosisEmbolism and ThrombosisVascular DiseasesCardiomegalyCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Stephen E. Kimmel, MD, MSCE/Director, Clinical Epidemiology
Organization
University of Pennsylvania Perelman School of Medicine
stevek@mail.med.upenn.edu
(215) 898-1740

Study Officials

  • Kevin Volpp, M.D., Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2012

Study Completion

December 1, 2013

Last Updated

March 16, 2017

Results First Posted

March 16, 2017

Record last verified: 2017-01

Locations

US(2)