Social Forces to Improve Statin Adherence (Study A)



Status:Completed
Conditions:High Blood Pressure (Hypertension), Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:January 2014
End Date:October 2014
Contact:Adam S Mussell, MA
Email:adam.mussell@uphs.upenn.edu
Phone:215-746-4177

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Using Social Support To Improve Medication Adherence In Statin Users With Diabetes

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.

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

- 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:
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