NCT02018809

Social Forces to Improve Statin Adherence (Study A)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Medication Adherence
• High Blood Pressure
• Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Medication Adherence Partner
DEVICE	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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-10-01
• Completion: 2015-01-01
• First posted: 2013-12-23
• Last updated: 2017-09-14
• Results posted: 2017-05-23

Locations

1 site across 1 country: United States