Social Forces to Improve Statin Adherence (Study A)

N/ACompletedNCT02018809

University of Pennsylvania200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Medication Adherence High Blood Pressure Diabetes

Interventions

Medication Adherence PartnerBEHAVIORAL

Electronic pill bottleDEVICE

This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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:

Locations (1)

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Statin Adherence

The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.

Time frame: 90 days

Secondary Outcomes

Morisky Medication Adherence Scale (MMAS)

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.

Time frame: 90 days

Data from ClinicalTrials.gov

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