Trial Outcomes & Findings for Social Forces to Improve Statin Adherence (Study B) (NCT NCT02148523)
NCT ID: NCT02148523
Last Updated: 2017-07-13
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
201 participants
Primary outcome timeframe
90 days
Results posted on
2017-07-13
Participant Flow
Participant milestones
| Measure |
Weekly Adherence Report
Adherence report to subject every 7 days.
Adherence feedback
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.
|
Weekly Adherence Peer-Comparison Report
Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
Comparison to peers
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
|
67
|
67
|
67
|
|
Overall Study
COMPLETED
|
67
|
67
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Social Forces to Improve Statin Adherence (Study B)
Baseline characteristics by cohort
| Measure |
Weekly Adherence Report
n=67 Participants
Adherence report to subject every 7 days.
Adherence feedback
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.
|
Weekly Adherence Peer-Comparison Report
n=67 Participants
Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
Comparison to peers
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=67 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=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 11 • n=5 Participants
|
68 years
STANDARD_DEVIATION 10 • n=7 Participants
|
67 years
STANDARD_DEVIATION 10 • n=5 Participants
|
67 years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
193 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 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
|
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 |
Weekly Adherence Report
n=67 Participants
Adherence report to subject every 7 days.
Adherence feedback
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.
|
Weekly Adherence Peer-Comparison Report
n=67 Participants
Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
Comparison to peers
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=67 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
|
79 percentage of correct statin doses
Standard Deviation .26
|
84 percentage of correct statin doses
Standard Deviation .23
|
80 percentage of correct statin doses
Standard Deviation .23
|
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 |
Weekly Adherence Report
n=67 Participants
Adherence report to subject every 7 days.
Adherence feedback
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.
|
Weekly Adherence Peer-Comparison Report
n=67 Participants
Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
Comparison to peers
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=67 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)
|
6 units on a scale
Interval 4.75 to 7.0
|
6 units on a scale
Interval 5.0 to 7.0
|
5.5 units on a scale
Interval 4.75 to 7.0
|
Adverse Events
Weekly Adherence Report
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Weekly Adherence Peer-Comparison Report
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