Social Forces to Improve Statin Adherence (Study A)

Not Applicable

Completed

Interventions: Behavioral: Medication Adherence Partner
Device: Electronic pill bottle

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.

Recruitment & Eligibility

Inclusion Criteria

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:

Arm && Interventions

Group	Intervention	Description
MAP Missed Doses	Medication Adherence Partner	The subject's MAP receives notification if the subject missed \>2 consecutive daily doses of statin.
Usual Care	Electronic pill bottle	Usual care with GlowCap.
MAP Daily Notification	Medication Adherence Partner	The subject's MAP receives daily notification about whether subject took statin.
MAP Weekly Notification	Electronic pill bottle	The subject's MAP receives weekly about how often the subject took statin during previous week.
MAP Weekly Notification	Medication Adherence Partner	The subject's MAP receives weekly about how often the subject took statin during previous week.
MAP Daily Notification	Electronic pill bottle	The subject's MAP receives daily notification about whether subject took statin.
MAP Missed Doses	Electronic pill bottle	The subject's MAP receives notification if the subject missed \>2 consecutive daily doses of statin.

Primary Outcome Measures

Name	Time	Method
Statin Adherence	90 days	The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.

Secondary Outcome Measures

Name	Time	Method
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.

Locations (1): University of Pennsylvania Perelman School of Medicine
🇺🇸
Philadelphia, Pennsylvania, United States