Social Forces to Improve Statin Adherence (Study A)

Study Overview
=================
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.

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

Conditions
-----------------
Medication Adherence, High Blood Pressure, Diabetes

Intervention / Treatment
-----------------
* Behavioral: Medication Adherence Partner
* Device: Electronic pill bottle


Participation Criteria
=================
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:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAP Daily Notification<br>The subject's MAP receives daily notification about whether subject took statin. | Behavioral: Medication Adherence Partner<br> <br> Device: Electronic pill bottle<br>* This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.<br>* Other names: Vitality GlowCap;|
| Experimental: MAP Weekly Notification<br>The subject's MAP receives weekly about how often the subject took statin during previous week. | Behavioral: Medication Adherence Partner<br> <br> Device: Electronic pill bottle<br>* This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.<br>* Other names: Vitality GlowCap;|
| Experimental: MAP Missed Doses<br>The subject's MAP receives notification if the subject missed >2 consecutive daily doses of statin. | Behavioral: Medication Adherence Partner<br> <br> Device: Electronic pill bottle<br>* This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.<br>* Other names: Vitality GlowCap;|
| Other: Usual Care<br>Usual care with GlowCap. | Device: Electronic pill bottle<br>* This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.<br>* Other names: Vitality GlowCap;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statin Adherence | The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morisky Medication Adherence Scale (MMAS) | 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. | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medication Adherence, High Blood Pressure, Diabetes, Statins