Using Social Comparison To Improve Medication Adherence In Statin Users With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Statin Adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Weekly Adherence Report
Adherence report to subject every 7 days.
干预措施: Adherence feedback (Behavioral)
Weekly Adherence Peer-Comparison Report
Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
干预措施: Electronic pill bottle (Device)
Usual Care
Usual care with GlowCap.
干预措施: Electronic pill bottle (Device)
Weekly Adherence Report
Adherence report to subject every 7 days.
干预措施: Electronic pill bottle (Device)
Weekly Adherence Peer-Comparison Report
Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
干预措施: Comparison to peers (Behavioral)
结局指标
主要结局
Statin Adherence
时间窗: 90 days
The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.
次要结局
- Morisky Medication Adherence Scale (MMAS)(90 days)