Social Forces to Improve Statin Adherence (Study A)

August 15, 2017 updated by: University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Perelman School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MAP Daily Notification
The subject's MAP receives daily notification about whether subject took statin.
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.
Other Names:
  • Vitality GlowCap
Experimental: MAP Weekly Notification
The subject's MAP receives weekly about how often the subject took statin during previous week.
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.
Other Names:
  • Vitality GlowCap
Experimental: MAP Missed Doses
The subject's MAP receives notification if the subject missed >2 consecutive daily doses of statin.
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.
Other Names:
  • Vitality GlowCap
Other: Usual Care
Usual care with GlowCap.
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.
Other Names:
  • Vitality GlowCap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Peter P Reese, MD, MSCE, UPenn PSOM
  • Principal Investigator: Judd B Kessler, PhD, UPenn, Wharton
  • Principal Investigator: Kevin Volpp, MD, PhD, UPenn, PSOM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 819129-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on Medication Adherence Partner

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe