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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAP Daily Notification | Experimental | The subject's MAP receives daily notification about whether subject took statin. |
|
| MAP Weekly Notification | Experimental | The subject's MAP receives weekly about how often the subject took statin during previous week. |
|
| MAP Missed Doses | Experimental | The subject's MAP receives notification if the subject missed >2 consecutive daily doses of statin. |
|
| Usual Care | Other | Usual care with GlowCap. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication Adherence Partner | Behavioral |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Statin Adherence | The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter P Reese, MD, MSCE | UPenn PSOM | Principal Investigator |
| Judd B Kessler, PhD | UPenn, Wharton | Principal Investigator |
| Kevin Volpp, MD, PhD | UPenn, PSOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Statin Adherence | The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps. | Posted | Mean | Standard Deviation | percentage of correct statin doses | 90 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The interventions lasted only 3 months; differences in adherence might emerge over a longer period of time. The primary outcome of pill-bottle-measured adherence has limitations, including bottle malfunction.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter P. Reese | University of Pennsylvania | 215-898-6086 | peter.reese@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| Electronic pill bottle |
| Device |
This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial. |
|
|
| 90 days |
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | 90 days |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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. | 0 | 50 | 0 | 50 |
| EG002 | 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. | 0 | 50 | 0 | 50 |
| EG003 | 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. | 0 | 50 | 0 | 50 |
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| D001519 | Behavior |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |