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临床试验/NCT01123928
NCT01123928已完成不适用

The Effect of Counseling in Cataract Screening: Guangdong Uptake of Surgery Trial

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 434 人开始时间: 2010年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
434
试验地点
1
主要终点
Decision to Undergo Cataract Surgery (Surgery Acceptance)

研究概览

简要总结

The purpose of this study is:

  1. To determine whether an educational intervention designed based on studies in the area is effective in increasing acceptance of surgery and presentation to the hospital, when adjusting for a number of potential determinants of service uptake;
  2. To assess short-term impact of the educational intervention on knowledge about cataract and attitudes toward locally-available surgical services.

详细描述

China is home to the 18% of the world's blind people, an estimated 6.6 million. In China, cataract is the leading cause of blindness. In Guangdong, current counseling measures for patients diagnosed with cataract are minimal and often lack adequate descriptions of what cataract is, what causes cataract, and benefits/risks of surgery. A counseling session for cataract patients and family members, conducted by a trained nurse during outreach screening, may increase subsequent attendance at pre-operative examination, acceptance of cataract surgery, and attendance at follow-up examinations. An integral part of this counseling is a short movie consisting of testimony from a former cataract patient who underwent surgery ("pseudophakic motivator"). The use of pseudophakic motivators have been shown to be effective in increasing surgical uptake. In addition, a previously validated "Barriers Questionnaire" will be used to assess predictors of of hospital attendance, surgery acceptance, and follow-up attendance in the categories of cost, transportation, knowledge, and concerns about quality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • thought by the examiner to have age-related or myopic cataract in one or both eyes
  • pinhole-corrected visual acuity less than or equal to 6/18.

排除标准

  • traumatic cataract
  • inability to give informed consent due to dementia or other reasons.

结局指标

主要结局

Decision to Undergo Cataract Surgery (Surgery Acceptance)

时间窗: within 6 months after screening examination

Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects.

次要结局

  • Attendance at Hospital for Pre-operative Examination(within 6 months after screening examination)
  • Knowledge That Cataract Can be Treated(Assessed during day of screening examination)
  • Belief That Doctors and Nurses at the Hospital Have "Very Good" Attitudes(Assessed during day of screening examination)
  • Belief That Vision Will Improve "a Lot" Following Surgery(Assessed during day of screening examination)
  • Belief That Surgery Will be Painful(Assessed during day of screening examination)
  • Belief That Surgeons at the Hospital Are "Highly Skilled"(Assessed during day of screening examination)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Congdon Nathan

Dr. Nathan Congdon, MD, MPH

Sun Yat-sen University

研究点 (1)

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