Trial Outcomes & Findings for Randomized Trial of Interventions to Improve Warfarin Adherence (NCT NCT00904982)
NCT ID: NCT00904982
Last Updated: 2017-03-16
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
268 participants
Primary outcome timeframe
six months
Results posted on
2017-03-16
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
68
|
67
|
67
|
68
|
|
Overall Study
COMPLETED
|
66
|
67
|
67
|
68
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
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.
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Randomized Trial of Interventions to Improve Warfarin Adherence
Baseline characteristics by cohort
| Measure |
1 Usual Care Group/Control
n=68 Participants
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
|
2Med-eMonitor/Reminder
n=67 Participants
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.
|
3 Incentive Group/Lottery
n=67 Participants
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
|
4 Combined Group/Lottery and Reminder
n=68 Participants
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
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
62 years
n=7 Participants
|
62 years
n=5 Participants
|
61.5 years
n=4 Participants
|
62 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
184 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
67 participants
n=7 Participants
|
67 participants
n=5 Participants
|
68 participants
n=4 Participants
|
270 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: six monthsPopulation: This analysis required multiple INR results. If those were not available for a subject, they were excluded from the primary analysis.
Outcome measures
| Measure |
1 Usual Care Group/Control
n=66 Participants
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
|
2Med-eMonitor/Reminder
n=64 Participants
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.
|
3 Incentive Group/Lottery
n=64 Participants
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
|
4 Combined Group/Lottery and Reminder
n=67 Participants
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
|
|---|---|---|---|---|
|
Improved Warfarin Adherence/% Timeout of Target INR Range
|
31.6 percentage of out of target INR range
Interval 11.1 to 50.5
|
23.8 percentage of out of target INR range
Interval 8.8 to 36.6
|
30.1 percentage of out of target INR range
Interval 12.4 to 46.3
|
23.9 percentage of out of target INR range
Interval 9.9 to 42.7
|
Adverse Events
1 Usual Care Group/Control
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
2Med-eMonitor/Reminder
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
3 Incentive Group/Lottery
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
4 Combined Group/Lottery and Reminder
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 Usual Care Group/Control
n=65 participants at risk
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
|
2Med-eMonitor/Reminder
n=63 participants at risk
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.
|
3 Incentive Group/Lottery
n=65 participants at risk
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
|
4 Combined Group/Lottery and Reminder
n=66 participants at risk
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
|
|---|---|---|---|---|
|
Nervous system disorders
Stroke/TIA
|
0.00%
0/65
|
0.00%
0/63
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
|
Vascular disorders
Non-CNS Thrombosis
|
0.00%
0/65
|
0.00%
0/63
|
3.1%
2/65 • Number of events 2
|
0.00%
0/66
|
|
Blood and lymphatic system disorders
Major Bleeding
|
6.2%
4/65 • Number of events 4
|
6.3%
4/63 • Number of events 4
|
3.1%
2/65 • Number of events 2
|
7.6%
5/66 • Number of events 5
|
Other adverse events
| Measure |
1 Usual Care Group/Control
n=65 participants at risk
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
|
2Med-eMonitor/Reminder
n=63 participants at risk
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.
|
3 Incentive Group/Lottery
n=65 participants at risk
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
|
4 Combined Group/Lottery and Reminder
n=66 participants at risk
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
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Non-Serious Bleeding
|
0.00%
0/65
|
4.8%
3/63 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
6.1%
4/66 • Number of events 4
|
|
Blood and lymphatic system disorders
Non-serious Clotting
|
1.5%
1/65 • Number of events 1
|
0.00%
0/63
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
Additional Information
Stephen E. Kimmel, MD, MSCE/Director, Clinical Epidemiology
University of Pennsylvania Perelman School of Medicine
Phone: (215) 898-1740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place