Atrial Fibrillation, Deep Vein Thrombosis, Dilated Cardiomyopathies
Conditions
Keywords
warfarin, coumadin, adherence, mechanical heart valves
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.
Interventions
BEHAVIORALFinancial 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.
DEVICE2Med-eMonitor
Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improved Warfarin Adherence/% Timeout of Target INR Range | six months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 Usual Care Group/Control 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.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 | 68 |
| 2Med-eMonitor/Reminder 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.
2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence. | 67 |
| 3 Incentive Group/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. 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.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 | 67 |
| 4 Combined Group/Lottery and Reminder 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.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 an | 68 |
| Total | 270 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 1 Usual Care Group/Control | 2Med-eMonitor/Reminder | 3 Incentive Group/Lottery | 4 Combined Group/Lottery and Reminder | Total |
|---|---|---|---|---|---|
| Age, Continuous | 64 years | 62 years | 62 years | 61.5 years | 62 years |
| Region of Enrollment United States | 68 participants | 67 participants | 67 participants | 68 participants | 270 participants |
| Sex: Female, Male Female | 23 Participants | 17 Participants | 21 Participants | 25 Participants | 86 Participants |
| Sex: Female, Male Male | 45 Participants | 50 Participants | 46 Participants | 43 Participants | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 65 | 3 / 63 | 2 / 65 | 5 / 66 |
| serious Total, serious adverse events | 4 / 65 | 4 / 63 | 4 / 65 | 5 / 66 |
Outcome results
Primary
Improved Warfarin Adherence/% Timeout of Target INR Range
Time frame: six months
Population: This analysis required multiple INR results. If those were not available for a subject, they were excluded from the primary analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1 Usual Care Group/Control | Improved Warfarin Adherence/% Timeout of Target INR Range | 31.6 percentage of out of target INR range |
| 2Med-eMonitor/Reminder | Improved Warfarin Adherence/% Timeout of Target INR Range | 23.8 percentage of out of target INR range |
| 3 Incentive Group/Lottery | Improved Warfarin Adherence/% Timeout of Target INR Range | 30.1 percentage of out of target INR range |
| 4 Combined Group/Lottery and Reminder | Improved Warfarin Adherence/% Timeout of Target INR Range | 23.9 percentage of out of target INR range |