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临床试验/NCT00756184
NCT00756184已完成4 期

1-year Randomized Control Trial Investigating the Value of an Intervention to Enhance Adherence in Glaucoma Patients Receiving Prostaglandin Monotherapy and in Patients Who Are Candidates for Adjunctive Therapy

Aristotle University Of Thessaloniki0 个研究点目标入组 107 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
107
主要终点
Adherence rate between intervention and control groups

研究概览

简要总结

A one-year, randomized, attention placebo-controlled trial investigating the value of comprehensive adherence specific interventions, over the course of one year, to enhance adherence in both (a) newly diagnosed open-angle glaucoma, or ocular hypertension patients, naive to medical therapy and (b) those who have failed monotherapy with any prostaglandin analogue (and are therefore candidates for adjunctive therapy) who then are randomized to receive only travoprost monotherapy. Subjects will be randomized to two different interventions involving direct physician education, each of which will take approximately the same amount of physician time: The first will be intensive adherence education that will continue throughout the year. The second will be intensive eye care education, but without any direct adherence education. All patients participating in the study will be monitored for adherence by the TDA. The study will demonstrate for the first time the role of adherence-specific training in improving patient adherence and will validate the TDA in monitoring and improving adherence in glaucoma. This will correlate with prior work that has documented that greater adherence is associated with marked improvement in intraocular pressure (IOP) control. A second goal will be seeing whether improving adherence will change the course of glaucoma therapy by making therapeutic failures into therapeutic successes by reducing the need for adjunctive therapy using only monotherapy with travoprost.

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
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed patients with glaucoma
  • Suboptimally controlled patients with glaucoma
  • Untreated baseline IOP greater than 21 mm Hg but less than 32 mm Hg
  • Patients who have not responded satisfactorily to PGA therapy
  • Patients who are about to have adjunctive therapy administered
  • Patients who consent to participate in this trial

排除标准

  • Glaucoma patients with high pressure
  • Advanced glaucoma
  • Patients with side effects to PGA therapy
  • Unwilling to participate

结局指标

主要结局

Adherence rate between intervention and control groups

时间窗: 1,3,6,12 months

次要结局

  • IOP control(12 months)

研究者

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

AGP Konstas

Professor in Ophthalmology

Aristotle University Of Thessaloniki

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