Social Forces to Improve Statin Adherence (Study B)

NCT ID: NCT02148523

Last Updated: 2017-07-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Medication Adherence High Blood Pressure Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Weekly Adherence Report

Adherence report to subject every 7 days.

Group Type EXPERIMENTAL

Adherence feedback

Intervention Type BEHAVIORAL

Electronic pill bottle

Intervention Type 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.

Weekly Adherence Peer-Comparison Report

Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.

Group Type EXPERIMENTAL

Comparison to peers

Intervention Type BEHAVIORAL

Electronic pill bottle

Intervention Type 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.

Usual Care

Usual care with GlowCap.

Group Type OTHER

Electronic pill bottle

Intervention Type 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.

Interventions

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Comparison to peers

Intervention Type BEHAVIORAL

Adherence feedback

Intervention Type BEHAVIORAL

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.

Intervention Type DEVICE

Other Intervention Names

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Vitality GlowCap

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter P Reese, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

UPenn, PSOM

Judd B Kessler, PhD

Role: PRINCIPAL_INVESTIGATOR

UPenn, Wharton

Kevin Volpp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UPenn, PSOM

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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819129-B

Identifier Type: -

Identifier Source: org_study_id

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