Social Forces to Improve Statin Adherence (Study B)

Study Overview
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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.

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

Conditions
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Medication Adherence, High Blood Pressure, Diabetes

Intervention / Treatment
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* Behavioral: Comparison to peers
* Behavioral: Adherence feedback
* Device: Electronic pill bottle


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly Adherence Report<br>Adherence report to subject every 7 days. | Behavioral: Adherence feedback<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: Weekly Adherence Peer-Comparison Report<br>Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence. | Behavioral: Comparison to peers<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?
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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
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Keywords Provided by Centre Hospitalier Valida
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Statins, Medication Adherence, High Blood Pressure, Diabetes