跳至主要内容
临床试验/NCT04345731
NCT04345731已完成不适用

Over-the-counter (OTC) Labels for Older Adults

Michigan State University2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2018年7月16日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Becker

Professor Department of Psychology

Michigan State University

研究点 (2)

Loading locations...

相似试验