Randomized Trial of Interventions to Improve Warfarin Adherence

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deep Vein Thrombosis Dilated Cardiomyopathies Embolism and Thrombosis Genetic Diseases, Inborn Heart Diseases Laminopathies Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania Anticoagulation Management Center, Philadelphia, Pennsylvania, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Financial Incentive and Med-eMonitor

Behavioral

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-eMonitor

Device

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

Primary outcomes

Improved Warfarin Adherence/% Timeout of Target INR Range

Time frame: six months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: WIN3

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2013
First posted: May 20, 2009
Registry last updated: Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed