Diabetes, High Blood Pressure, Medication Adherence
Conditions
Keywords
Medication Adherence, High Blood Pressure, Diabetes, Statins
Brief summary
To assess the effectiveness of social comparison in improving the outcome of statin adherence versus usual care as measured by an electronic pill bottle. Subjects receiving weekly reports with their adherence and information about their place in the distribution of their peers will have the highest statin adherence of any arm, as measured by electronic pill bottle.
Detailed description
We propose to complete a randomized controlled trial (RCT) of 201 subjects with medication treated diabetes and evidence of poor adherence to a statin medication (\<70% medication possession ratio (MPR) determined through pharmacy records; no combination meds). Study subjects will use GlowCaps to store their statin medication. Arm 1 will receive weekly feedback containing general information about the subject's adherence (i.e., reminding the subject how many days that week he or she took the medication). Arm 2 will be provided the same weekly feedback and the information of whether his or her adherence is above or below the average adherence in their arm, along with a message of encouragement tailored to their place in the arm distribution. Subjects with perfect adherence will receive: You took your pill every day for the last 7 days. Great job! Keep it up with their weekly adherence report. Subjects with less than perfect adherence and adherence rate in the top 50% of the arm will receive: You took your pill for \*\* days out of the last 7 days. Your medication adherence was as good or better than half of people in this study. Taking your pill every day would improve your health even more with their weekly adherence report. Subjects with less than perfect adherence and adherence rate in the bottom 50% of the arm will receive: You took your pill for \*\* days out of the last 7 days. Your medication adherence was in the bottom half of the people in this study. If you took your pill more often, you could be in the top half of people in the study with their weekly adherence report. Adherence records will be displayed on each subject's Way to Health (WTH) account in all arms. Arm 3 will be the usual care control.
Interventions
BEHAVIORALComparison to peers
BEHAVIORALAdherence feedback
DEVICEElectronic 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.
Sponsors
Merck Sharp & Dohme LLC
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is Humana insured * The subject is an English speaking adult * Age range ≥18 years * The subject has diagnosis with diabetes for ≥12 months * The subject has an MPR \<70% to a statin medication * Subjects denies side-effects to their statin medication
Exclusion criteria
* The subject is \<18 years old * The subject is considered part of a vulnerable population (is a prisoner, a cognitively impaired person, or a pregnant woman) * On statin combination medication * The subject does not identify an individual who agrees to serve as their MAP * The subject reports a clinically important side effect to the statin medication or active liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Statin Adherence | 90 days | The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morisky Medication Adherence Scale (MMAS) | 90 days | The 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 67 |
| 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. | 67 |
| 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. | 67 |
| Total | 201 |
Baseline characteristics
| Characteristic | Weekly Adherence Report | Weekly Adherence Peer-Comparison Report | Usual Care | Total |
|---|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 11 | 68 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 63 Participants | 65 Participants | 193 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 8 Participants | 2 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 54 Participants | 56 Participants | 63 Participants | 173 Participants |
| Sex: Female, Male Female | 34 Participants | 25 Participants | 28 Participants | 87 Participants |
| Sex: Female, Male Male | 33 Participants | 42 Participants | 39 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 67 | 0 / 67 | 0 / 67 |
| serious Total, serious adverse events | 0 / 67 | 0 / 67 | 0 / 67 |
Outcome results
Primary
Statin Adherence
The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weekly Adherence Report | Statin Adherence | 79 percentage of correct statin doses | Standard Deviation 0.26 |
| Weekly Adherence Peer-Comparison Report | Statin Adherence | 84 percentage of correct statin doses | Standard Deviation 0.23 |
| Usual Care | Statin Adherence | 80 percentage of correct statin doses | Standard Deviation 0.23 |
Secondary
Morisky Medication Adherence Scale (MMAS)
The 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.
Time frame: 90 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Weekly Adherence Report | Morisky Medication Adherence Scale (MMAS) | 6 units on a scale |
| Weekly Adherence Peer-Comparison Report | Morisky Medication Adherence Scale (MMAS) | 6 units on a scale |
| Usual Care | Morisky Medication Adherence Scale (MMAS) | 5.5 units on a scale |