Social Forces to Improve Statin Adherence (Study B)

July 11, 2017 updated by: University of Pennsylvania

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

To assess the effectiveness of social comparison in improving the outcome of statin adherence versus usual care as measured by an electronic pill bottle.

Subjects receiving weekly reports with their adherence and information about their place in the distribution of their peers will have the highest statin adherence of any arm, as measured by electronic pill bottle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We propose to complete a randomized controlled trial (RCT) of 201 subjects with medication treated diabetes and evidence of poor adherence to a statin medication (<70% medication possession ratio (MPR) determined through pharmacy records; no combination meds). Study subjects will use GlowCaps to store their statin medication.

Arm 1 will receive weekly feedback containing general information about the subject's adherence (i.e., reminding the subject how many days that week he or she took the medication). Arm 2 will be provided the same weekly feedback and the information of whether his or her adherence is above or below the average adherence in their arm, along with a message of encouragement tailored to their place in the arm distribution. Subjects with perfect adherence will receive: "You took your pill every day for the last 7 days. Great job! Keep it up" with their weekly adherence report. Subjects with less than perfect adherence and adherence rate in the top 50% of the arm will receive: "You took your pill for ** days out of the last 7 days. Your medication adherence was as good or better than half of people in this study. Taking your pill every day would improve your health even more" with their weekly adherence report. Subjects with less than perfect adherence and adherence rate in the bottom 50% of the arm will receive: "You took your pill for ** days out of the last 7 days. Your medication adherence was in the bottom half of the people in this study. If you took your pill more often, you could be in the top half of people in the study" with their weekly adherence report. Adherence records will be displayed on each subject's Way to Health (WTH) account in all arms. Arm 3 will be the usual care control.

Study Type

Interventional

Enrollment (Actual)

201

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

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
  • Subjects denies side-effects to their statin medication

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
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
Experimental: Weekly Adherence Report
Adherence report to subject every 7 days.
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
Behavioral: Adherence feedback
Experimental: Weekly Adherence Peer-Comparison Report
Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
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
Behavioral: Comparison to peers

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

May 22, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 819129-B

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.

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