Clinical trial NCT02148523: Social Forces to Improve Statin Adherence (Study B)
Official title: Using Social Comparison To Improve Medication Adherence In Statin Users With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
High Blood Pressure
Diabetes
Keywords: Medication Adherence
High Blood Pressure
Diabetes
Statins
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-05-28
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

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
* 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

Primary outcomes:
measure: Statin Adherence
timeFrame: 90 days
Secondary outcomes:
measure: Morisky Medication Adherence Scale (MMAS)
timeFrame: 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: UPenn, PSOM
name: Peter P Reese, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: UPenn, Wharton
name: Judd B Kessler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UPenn, PSOM
name: Kevin Volpp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: