Skip to main content
OpenTrials
Completed

NCT Number: NCT02148523

Social Forces to Improve Statin Adherence (Study B)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Medication Adherence Behavior Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior High Blood Pressure Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

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
  • 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

Treatment and study plan

Comparison to peers

Behavioral

Adherence feedback

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 Comparison To Improve Medication Adherence In Statin Users With Diabetes

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
May 28, 2014
Registry last updated
Jul 13, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.