Trial Outcomes & Findings for Social Forces to Improve Statin Adherence (Study A) (NCT NCT02018809)
NCT ID: NCT02018809
Last Updated: 2017-09-14
Results Overview
The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
90 days
Results posted on
2017-09-14
Participant Flow
Participant milestones
| Measure |
MAP Daily Notification
The subject's MAP receives daily notification about whether subject took statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
MAP Weekly Notification
The subject's MAP receives weekly about how often the subject took statin during previous week.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
MAP Missed Doses
The subject's MAP receives notification if the subject missed \>2 consecutive daily doses of statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
Usual Care
Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Social Forces to Improve Statin Adherence (Study A)
Baseline characteristics by cohort
| Measure |
MAP Daily Notification
n=50 Participants
The subject's MAP receives daily notification about whether subject took statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
MAP Weekly Notification
n=50 Participants
The subject's MAP receives weekly about how often the subject took statin during previous week.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
MAP Missed Doses
n=50 Participants
The subject's MAP receives notification if the subject missed \>2 consecutive daily doses of statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
Usual Care
n=50 Participants
Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 10 • n=5 Participants
|
66 years
STANDARD_DEVIATION 10 • n=7 Participants
|
65 years
STANDARD_DEVIATION 9 • n=5 Participants
|
67 years
STANDARD_DEVIATION 10 • n=4 Participants
|
66 years
STANDARD_DEVIATION 10 • n=21 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
188 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
174 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 90 daysThe primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.
Outcome measures
| Measure |
MAP Daily Notification
n=50 Participants
The subject's MAP receives daily notification about whether subject took statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
MAP Weekly Notification
n=50 Participants
The subject's MAP receives weekly about how often the subject took statin during previous week.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
MAP Missed Doses
n=50 Participants
The subject's MAP receives notification if the subject missed \>2 consecutive daily doses of statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
Usual Care
n=50 Participants
Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
|---|---|---|---|---|
|
Statin Adherence
|
86 percentage of correct statin doses
Standard Deviation .18
|
85 percentage of correct statin doses
Standard Deviation .20
|
86 percentage of correct statin doses
Standard Deviation .17
|
85 percentage of correct statin doses
Standard Deviation .15
|
SECONDARY outcome
Timeframe: 90 daysThe secondary outcome will be subjects' self-reports medication adherence. Morisky et al. developed this 8-item MMAS (MMAS-8) in 2008. The first seven items are Yes/No responses while the last item is a 5-point Likert response. The scoring scheme is: "Yes" = 0 and "No" = 1 (and "0" = 0 and "1-4" = 1 for Likert question). The items are summed to give a range of scores from 0 to 8. Respondents' summed score get grouped as follows: "0" = High Adherence; "1-2" = Medium Adherence; "3-8" = Low Adherence.
Outcome measures
| Measure |
MAP Daily Notification
n=50 Participants
The subject's MAP receives daily notification about whether subject took statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
MAP Weekly Notification
n=50 Participants
The subject's MAP receives weekly about how often the subject took statin during previous week.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
MAP Missed Doses
n=50 Participants
The subject's MAP receives notification if the subject missed \>2 consecutive daily doses of statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
Usual Care
n=50 Participants
Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
|
|---|---|---|---|---|
|
Morisky Medication Adherence Scale (MMAS)
|
5.38 units on a scale
Interval 4.0 to 6.75
|
6 units on a scale
Interval 4.75 to 7.0
|
5.75 units on a scale
Interval 4.75 to 7.0
|
5.75 units on a scale
Interval 4.75 to 7.0
|
Adverse Events
MAP Daily Notification
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MAP Weekly Notification
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MAP Missed Doses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place