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临床试验/NCT01200849
NCT01200849已完成不适用

Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use

Northwestern University2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2010年10月最近更新:
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
Understanding of prescription medication

研究概览

简要总结

The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx container label design to improve Spanish speaking patients' understanding of instructions for use.

详细描述

The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy of the enhanced Rx container label to improve, Spanish speaking, diabetic and/or hypertensive patients' understanding of actual prescribed medicines, compared to a standard label format. Spanish-speaking patients with type II diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts Central - NSC) receive all their prescribed medicines from this location. Recruited diabetic and/or hypertensive subjects in this study will be randomly assigned to either intervention (enhanced Rx container label) or control (standard Rx label). All pill-form, regular dosing schedule medicines, including diabetes and hypertensive (i.e. ACE inhibitor) medicines associated with patients' treatment will be labeled according to study arm by the central-fill pharmacy. Study subjects will be interviewed at the time of dispensing the prescribed medicines at the clinic, again three months later (dispensing of refill), and finally nine months after baseline (dispensing of refill). Pharmacy refill data and medical record information - linked at these clinics - will be collected for exploratory analyses. Patients' ability to read and demonstrate Rx label instructions, including auxiliary warnings, will be the primary outcomes for this aim. Data from the actual use trial will be processed, reviewed, analyzed (in order of hypotheses), and reports prepared during the final months of this last phase of the study. We anticipate several manuscripts to be developed as a result of this project, supported by the diverse key personnel and collaborating faculty enlisted.

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
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Type II diabetes or hypertension in their medical chart
  • Spanish speaking
  • 30 years or older

排除标准

  • Uncorrectable hearing or visual impairment.
  • Too ill to participate

结局指标

主要结局

Understanding of prescription medication

时间窗: Baseline, 3 month follow-up, 9 month follow-up

Difference in understanding and comprehension of medication use as compared to control.

次要结局

  • Change in HbA1c or blood pressure readings(Baseline, 3 month follow-up, 9 month follow-up)

研究者

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

Michael S. Wolf

Professor

Northwestern University

研究点 (2)

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