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临床试验/NCT01416415
NCT01416415终止不适用

Glaucoma Eye Drop Instillation: Impact of Education

Northwestern University2 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2011年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
119
试验地点
2
主要终点
Eye drop instillation score

研究概览

简要总结

The purpose of this study is to assess whether an educational intervention will have a positive effect on patients' ability to properly administer eye drops. The investigators predict that the educational intervention will have a positive impact on the efficacy, safety, and efficiency with which patients administer their eye drops.

详细描述

Glaucoma is a leading cause of irreversible vision loss worldwide, and as such has a large public health impact. The only treatment proven to slow or arrest the progression of the disease process is intraocular pressure (IOP) reduction, which relies heavily on patient cooperation. Previously, nonadherence to glaucoma medications has ranged from 24% to 59%. Barriers to medication compliance in the glaucoma patient population include health literacy, poor comprehension of disease, poor comprehension of medication regimen, and improper eye drop administration technique. The purpose of this randomized, controlled clinical trial is to assess whether an educational intervention will have a positive effect on patients' ability to properly administer eye drops. Patients randomized to the experimental group will receive the educational intervention, consisting of an instructional video demonstrating how to instill eyedrops. Patients randomized to the control group will receive an attention placebo, consisting of a video regarding healthy eating tips. Additional measures that will be obtained from all patients include a health literacy score, as measured using the REALM questionnaire, and a BMQ - specific score (Beliefs about Medicines Questionnaire) using the BMQ-specific questionnaire. If the education protocol is found to positively affect eye drop administration success, as demonstrated by a statistically significant difference between the experimental and control groups, suggestions will be proposed for the implementation of educational programs similar to ours to improve glaucoma patient outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Established care with the treating ophthalmologist for at least 6 months
  • Diagnosis of open-angle glaucoma or ocular hypertension
  • The use of one, two or three self-instilled eye drop medications in one or two eyes
  • Age 40-85 years
  • Fluency in English
  • Best corrected visual acuity (BCVA) of 20/50 or better in each eye

排除标准

  • Presence of moderate to severe cognitive deficits
  • Presence of a clinically significant tremor
  • Mini Mental Status Exam score ≤ 20

研究组 & 干预措施

Educational intervention

Experimental

The educational intervention arm will contain subjects who will watch a video on proper eye drop instillation technique.

干预措施: Video education on proper eye drop instillation technique (Other)

Attention placebo

Placebo Comparator

The attention control placebo group will receive an educational intervention that mimics the amount of time and attention received by the treatment group. The video chosen is regarding healthy eating tips.

干预措施: Placebo video education on healthy eating tips (Other)

结局指标

主要结局

Eye drop instillation score

时间窗: 4 +/- 3 months

The eye drop instillation score is a composite score of the efficacy, safety, and efficiency with which the subject instills their eyedrops and is simply a measure of how well the subject administers their eyedrops.

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

Angelo Tanna

Vice Chairman, Department of Ophthalmology and Director, Glaucoma Service

Northwestern University

研究点 (2)

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