Social Forces to Improve Statin Adherence (Study A)

NCT02018809 | Completed Results

• 1 other identifier: 819129-A
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence; High Blood Pressure; Diabetes

Keywords

Medication Adherence; High Blood Pressure; Diabetes; Statins

Outcome Measures

Primary Outcomes (1)

• Statin Adherence

  The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.

  90 days

Secondary Outcomes (1)

• Morisky Medication Adherence Scale (MMAS)

  90 days

Study Arms (4)

MAP Daily Notification

EXPERIMENTAL

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

Behavioral: Medication Adherence Partner; Device: Electronic pill bottle

MAP Weekly Notification

EXPERIMENTAL

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

Behavioral: Medication Adherence Partner; Device: Electronic pill bottle

MAP Missed Doses

EXPERIMENTAL

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

Behavioral: Medication Adherence Partner; Device: Electronic pill bottle

Usual Care

OTHER

Usual care with GlowCap.

Device: Electronic pill bottle

Interventions

Medication Adherence Partner BEHAVIORAL

MAP Daily Notification; MAP Missed Doses; MAP Weekly Notification

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.

Also known as: Vitality GlowCap

MAP Daily Notification; MAP Missed Doses; MAP Weekly Notification; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of Pennsylvania: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Medication Adherence; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The interventions lasted only 3 months; differences in adherence might emerge over a longer period of time. The primary outcome of pill-bottle-measured adherence has limitations, including bottle malfunction.

Results Point of Contact

• Title: Dr. Peter P. Reese
• Organization: University of Pennsylvania

peter.reese@uphs.upenn.edu

215-898-6086

Study Officials

• Peter P Reese, MD, MSCE

  UPenn PSOM

  PRINCIPAL INVESTIGATOR

• Judd B Kessler, PhD

  UPenn, Wharton

  PRINCIPAL INVESTIGATOR

• Kevin Volpp, MD, PhD

  UPenn, PSOM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: September 14, 2017
• Results First Posted: May 23, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)