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OpenTrials
Completed

NCT Number: NCT02018809

Social Forces to Improve Statin Adherence (Study A)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

Treatment and study plan

Medication Adherence Partner

Behavioral

Electronic pill bottle

Device

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

Other names: Vitality GlowCap

Primary outcomes

  1. Statin Adherence

    Time frame: 90 days

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

Secondary outcomes

  1. Morisky Medication Adherence Scale (MMAS)

    Time frame: 90 days

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 23, 2013
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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