Clinical trial NCT02018809: Social Forces to Improve Statin Adherence (Study A)
Official title: Using Social Support To Improve Medication Adherence In Statin Users With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
High Blood Pressure
Diabetes
Keywords: Medication Adherence
High Blood Pressure
Diabetes
Statins
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-12-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

Primary outcomes:
measure: Statin Adherence
timeFrame: 90 days
Secondary outcomes:
measure: Morisky Medication Adherence Scale (MMAS)
timeFrame: 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman School of Medicine
state: Pennsylvania
Study officials:
affiliation: UPenn PSOM
name: Peter P Reese, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: UPenn, Wharton
name: Judd B Kessler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UPenn, PSOM
name: Kevin Volpp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: