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Social Forces to Improve Statin Adherence (Study B)

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ClinicalTrials.gov Identifier: NCT02148523
Recruitment Status : Completed
First Posted : May 28, 2014
Results First Posted : May 23, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Medication Adherence High Blood Pressure Diabetes Behavioral: Comparison to peers Behavioral: Adherence feedback Device: Electronic pill bottle Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Using Social Comparison To Improve Medication Adherence In Statin Users With Diabetes
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Weekly Adherence Report
Adherence report to subject every 7 days.
 Behavioral: Adherence feedback
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 Name: Vitality GlowCap
Experimental: Weekly Adherence Peer-Comparison Report
Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
 Behavioral: Comparison to peers
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 Name: Vitality GlowCap
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 Name: Vitality GlowCap


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148523


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Merck Sharp & Dohme Corp.
Investigators
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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
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02148523    
Other Study ID Numbers: 819129-B
First Posted: May 28, 2014    Key Record Dates
Results First Posted: May 23, 2017
Last Update Posted: July 13, 2017
Last Verified: July 2017
Keywords provided by University of Pennsylvania:
Medication Adherence
High Blood Pressure
Diabetes
Statins
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases