Social Forces to Improve Statin Adherence (Study A)

University of Pennsylvania

Status: Completed

Conditions: Diabetes; High Blood Pressure; Medication Adherence

Treatments: Device: Electronic pill bottle; Behavioral: Medication Adherence Partner

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02018809

819129-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

MAP Daily Notification

Experimental group

Description:

The subject's MAP receives daily notification about whether subject took statin.

Treatment:

Device: Electronic pill bottle

Behavioral: Medication Adherence Partner

MAP Weekly Notification

Experimental group

Description:

The subject's MAP receives weekly about how often the subject took statin during previous week.

Treatment:

Device: Electronic pill bottle

Behavioral: Medication Adherence Partner

MAP Missed Doses

Experimental group

Description:

The subject's MAP receives notification if the subject missed \>2 consecutive daily doses of statin.

Treatment:

Device: Electronic pill bottle

Behavioral: Medication Adherence Partner

Usual Care

Other group

Description:

Usual care with GlowCap.

Treatment:

Device: Electronic pill bottle