Social Forces to Improve Statin Adherence (Study B)

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148523
• Other study ID #: 819129-B
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: July 11, 2017
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: July 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• 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

• 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

Related Conditions & MeSH terms

• Diabetes
• High Blood Pressure
• Hypertension
• Medication Adherence

Intervention

Behavioral:
• Comparison to peers

• Adherence feedback

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	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.	90 days
Secondary	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