Diabetes, High Blood Pressure, Medication Adherence
Conditions
Keywords
Medication Adherence, High Blood Pressure, Diabetes, Statins
Brief summary
To assess the effectiveness of reporting statin adherence patterns to a Medication Adherence Partner (MAP) in improving the outcome of statin adherence versus usual care as measured by an electronic pill bottle. Hypothesis: Subjects with a MAP receiving daily adherence feedback will have the highest statin adherence of any arm, as measured by pill bottle data.
Detailed description
We propose to complete a randomized controlled trial (RCT) of 200 subjects with medication treated diabetes and evidence of poor adherence to a statin medication (\<70% medication possession ratio determined through pharmacy records; no combination meds). Study subjects will use an electronic pill bottle (GlowCap) to store their statin medication. Study subjects will identify potential Medication Adherence Partners (MAPs) who can receive information about their adherence patterns at enrollment. For the 90-day trial, subjects will be randomized to: 1) the subject's MAP receives daily notification about whether subject took statin; 2) the subject's MAP receives weekly about how often the subject took statin during previous week; 3) the subject's MAP receives notification if the subject missed \>2 consecutive daily doses of statin; and 4) usual care (GlowCaps without any notifications). The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps. The secondary outcome will be subjects' statin medication possession ratio (MPR) during the study.
Interventions
BEHAVIORALMedication Adherence Partner
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 * Subject denies side-effects to their statin medication * The subject identified a person who agreed to serve as their MAP
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 |
|---|---|
| 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. | 50 |
| 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. | 50 |
| 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. | 50 |
| 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. | 50 |
| Total | 200 |
Baseline characteristics
| Characteristic | MAP Daily Notification | MAP Weekly Notification | MAP Missed Doses | Usual Care | Total |
|---|---|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 10 | 66 years STANDARD_DEVIATION 10 | 65 years STANDARD_DEVIATION 9 | 67 years STANDARD_DEVIATION 10 | 66 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 2 Participants | 1 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 45 Participants | 48 Participants | 49 Participants | 188 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 4 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 4 Participants | 0 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 41 Participants | 43 Participants | 45 Participants | 174 Participants |
| Sex: Female, Male Female | 30 Participants | 25 Participants | 22 Participants | 23 Participants | 100 Participants |
| Sex: Female, Male Male | 20 Participants | 25 Participants | 28 Participants | 27 Participants | 100 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 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
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 |
|---|---|---|---|
| MAP Daily Notification | Statin Adherence | 86 percentage of correct statin doses | Standard Deviation 0.18 |
| MAP Weekly Notification | Statin Adherence | 85 percentage of correct statin doses | Standard Deviation 0.2 |
| MAP Missed Doses | Statin Adherence | 86 percentage of correct statin doses | Standard Deviation 0.17 |
| Usual Care | Statin Adherence | 85 percentage of correct statin doses | Standard Deviation 0.15 |
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) |
|---|---|---|
| MAP Daily Notification | Morisky Medication Adherence Scale (MMAS) | 5.38 units on a scale |
| MAP Weekly Notification | Morisky Medication Adherence Scale (MMAS) | 6 units on a scale |
| MAP Missed Doses | Morisky Medication Adherence Scale (MMAS) | 5.75 units on a scale |
| Usual Care | Morisky Medication Adherence Scale (MMAS) | 5.75 units on a scale |