Social Forces to Improve Statin Adherence (Study A)

Diabetes Clinical Trial

Official title:

Using Social Support To Improve Medication Adherence In Statin Users With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018809
• Other study ID #: 819129-A
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: June 9, 2015
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: December 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• High Blood Pressure
• Hypertension
• Medication Adherence

Intervention

Behavioral:
• Medication Adherence Partner

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania Perelman School of Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Statin Adherence	The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.	Seven months (study duration)	No
Secondary	Statin Medication Possession Ratio (MPR)	The secondary outcome will be subjects' statin medication possession ratio during the study.	Seven months (study duration)	No