Social Forces to Improve Statin Adherence (Study A)

NCT ID: NCT02018809

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

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.

Conditions

Medication Adherence; High Blood Pressure; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MAP Daily Notification

The subject's MAP receives daily notification about whether subject took statin.

Group Type: EXPERIMENTAL

Medication Adherence Partner

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.

MAP Weekly Notification

The subject's MAP receives weekly about how often the subject took statin during previous week.

Group Type: EXPERIMENTAL

Medication Adherence Partner

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.

MAP Missed Doses

The subject's MAP receives notification if the subject missed \>2 consecutive daily doses of statin.

Group Type: EXPERIMENTAL

Medication Adherence Partner

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

Medication Adherence Partner

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

Vitality GlowCap

Eligibility 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
• 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:

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

819129-A

Identifier Type: -

Identifier Source: org_study_id