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临床试验/NCT03657147
NCT03657147已完成不适用

Improving African American Glaucoma Patient Involvement in Visits and Outcomes

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2018年9月10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
189
试验地点
2
主要终点
Intraocular Pressure

研究概览

简要总结

This is a research project about services provided to African American patients with glaucoma. The goal of the project is to improve communication between providers and African-American patients about glaucoma.

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

入选标准

  • African American
  • Age 18 or older
  • Able to speak and read English
  • Mentally competent to participate
  • Not blind (are at least 20/400 in their better seeing eye)
  • On one or more glaucoma medications
  • Report being less than 80% adherent to their glaucoma medications on a Visual Analog Scale

排除标准

  • < 18 years of age

结局指标

主要结局

Intraocular Pressure

时间窗: 12 months

Intraocular pressure measurements will be extracted from each patient's medical record at the baseline, 6 month, and 12 month follow-up visits. For all time points, a mean intraocular pressure will be calculated by averaging the intraocular pressure across both eyes. Change in intraocular pressure over the 12 month period will then be assessed by calculating the difference in mean intraocular pressure.

Glaucoma Medication Percent Adherence

时间窗: 12 months

Medication adherence will be measured using the number of recorded doses from the Medication Event Monitoring System (MEMS) data, divided by the number of prescribed doses. Medication adherence can range from 0% to 100%.

Glaucoma Medication Adherence Self-Efficacy Score

时间窗: 12 months

Medication adherence self-efficacy is measured using a 21-item scale that has a reliability of 0.89. Scores can range from 21 to 63, and a higher score indicates a better outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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