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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly Adherence Report | Experimental | Adherence report to subject every 7 days. |
|
| Weekly Adherence Peer-Comparison Report | Experimental | Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence. |
|
| Usual Care | Other | Usual care with GlowCap. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison to peers | Behavioral |
| ||
| Adherence feedback |
| 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 | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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 | 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. |
| BG001 | Weekly Adherence Peer-Comparison Report |
| 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 | 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. |
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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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| Behavioral |
|
| 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 |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 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 |
| 67 |
| 0 |
| 67 |
| EG001 | 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. | 0 | 67 | 0 | 67 |
| EG002 | 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 | 67 | 0 | 67 |
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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 |