Randomized Trial of Interventions to Improve Warfarin Adherence

Atrial Fibrillation Clinical Trial

— WIN3  

Official title:

Randomized Trial of Interventions to Improve Warfarin Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904982
• Other study ID #: 809166
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2009
• Last updated: December 15, 2015
• Start date: October 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: December 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiomyopathies
• Cardiomyopathy, Dilated
• Deep Vein Thrombosis
• Dilated Cardiomyopathies
• Venous Thrombosis

Intervention

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.

Device:
• 2Med-eMonitor
Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania Anticoagulation Management Center	Philadelphia	Pennsylvania
United States	Philadelphia Veteran Affairs Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved warfarin adherence		six months	No