Over-the-counter (OTC) Labels for Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Change Detection in Over the Counter Medicine Labels
研究概览
简要总结
Optimizing OTC labels for older adults: Empirical evaluation of labels designed to provide older users the information they need to to minimize adverse drug events
详细描述
The overarching goal is to design and evaluate a novel front of pack label for OTC drugs that will reduce the prevalence of Adverse Drug Reactions (ADRs) in older adults. To do so the researchers will survey pharmacists to ascertain which label information is most important to the reduction of ADRs, and then will design novel OTC labels which highlight this information. To evaluate the effectiveness of these designs, the investigators propose five experiments where older adults will make judgments about OTC appropriateness.
Study 1 - Survey of Pharmacists - Overseen by University of Wisconsin - Online Survey of pharmacists to evaluate which aspects in a drug facts labels are most critical to the reduction of adverse drug events.
Experiment 2 - Change Detection- Computer screen flashes between a label and the same label which has been modify slightly. Participant is instructed to locate the change as quickly as possible. Change should be detected more quickly for labels that engage users in bottom-up processing.
Experiment 3A- Absolute Judgement- Participant is asked a yes/no question about whether a product being displayed on a computer monitor is appropriate given a scenario. Half the scenarios involve active ingredient and half warning information. Time accuracy will indicate which labels are most effective.
Experiment 3B-Cross Product Comparison-Participant is given a scenario (that requires active ingredient or warning information) and is asked to select the appropriate OTC from a set of options(both products presented in identical labeling format within a trial). Again, speed an accuracy will be used to evaluate the most effective label designs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 110 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participant must be 65+
- •participant must be legally sighted
- •participant must be able purchase and administer their own medications
- •participant must be able to perform consent without assistance.
排除标准
- •if the participant has history of seizures
- •if the participant has impaired memory
结局指标
主要结局
Change Detection in Over the Counter Medicine Labels
时间窗: 60 minutes
Looks at differences between two sets of images of medicine labels and locates the change between two sets of labels.
次要结局
未报告次要终点
研究者
Mark Becker
Professor Department of Psychology
Michigan State University
