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Atrial FibrillationWIN3NCT00904982

Randomized Trial of Interventions to Improve Warfarin Adherence

A study testing Financial Incentive and Med-eMonitor and 2Med-eMonitor in people with Atrial Fibrillation and Deep Vein Thrombosis, run by University of Pennsylvania at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Financial Incentive and Med-eMonitor and 2Med-eMonitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
2 sitesUnited States
Study dates
Oct 2009to Dec 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Hospital of the University of Pennsylvania Anticoagulation Management Center

    Philadelphia, Pennsylvania, 19104

  • Philadelphia Veteran Affairs Medical Center

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the 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.

Being tested
Financial Incentive and Med-eMonitor, 2Med-eMonitor
Keywords
warfarin, coumadin, adherence, mechanical heart valves
Medical subject headings
Atrial Fibrillation, Venous Thrombosis, Cardiomyopathy, Dilated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Financial Incentive and Med-eMonitorBehavioural

    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.

  • 2Med-eMonitorDevice

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

Study groups in NCT00904982
Study groupRoleWhat they receive
1 Usual Care Group/ControlOtherParticipants 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.
Receives: Behavioral: Financial Incentive and Med-eMonitor
2Med-eMonitor/ReminderExperimentalParticipants 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.
Receives: Device: 2Med-eMonitor
3 Incentive Group/LotteryExperimentalParticipants 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.
Receives: Behavioral: Financial Incentive and Med-eMonitor
4 Combined Group/Lottery and ReminderExperimentalParticipants 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.
Receives: Behavioral: Financial Incentive and Med-eMonitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improved Warfarin Adherence/% Timeout of Target INR Range

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionMay 2012
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00904982
Sponsor's protocol ID
809166
Acronym
WIN3
Status last verified
Jan 2017
First submitted
18 May 2009
Last updated
16 Mar 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27592594

  • 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.

    PubMed 22877814

Questions about this trial

What is this clinical trial studying?

A study testing Financial Incentive and Med-eMonitor and 2Med-eMonitor in people with Atrial Fibrillation and Deep Vein Thrombosis, run by University of Pennsylvania at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improved Warfarin Adherence/% Timeout of Target INR Range (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00904982, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.

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