Using Social Support 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
- 200
- 试验地点
- 2
- 主要终点
- Statin Adherence
研究概览
简要总结
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.
详细描述
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.
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
- •Subject denies side-effects to their statin medication
- •The subject identified a person who agreed to serve as their MAP
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:
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)