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临床试验/NCT00545220
NCT00545220已完成不适用

Problem Solving Training and Low Vision Rehabilitation

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2007年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
430
试验地点
1
主要终点
Center for Epidemiological Studies Depression Scale (CES-D)

研究概览

简要总结

Vision loss can result in feelings of frustration, helplessness, anxiety, depression, and anger, which compromise a person's activities of everyday living. While emotional distress may resolve in some persons without intervention, unmanaged and persistent distress places the person at risk for continued decrements in health status and the potential development of more severe conditions (i.e., depression, poor health outcomes). Persons with low vision will be recruited and randomly assigned to either an innovative, problem-solving training (PST) intervention group designed specifically for persons with low vision or a sham intervention/control group. Primary and secondary outcomes will be assessed at baseline prior to intervention and at 3 month follow-up, 7 month follow-up, 12 month follow-up, and 24 month follow-up by a research interviewer masked to participants' randomization. This project will: (1) demonstrate how specified physical and emotional outcomes of persons with low vision change across time, (2) evaluate the effectiveness of a PST intervention that will be delivered to persons with low vision; and (3) identify persons with low vision who are at risk for adverse emotional and health outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •+19 yrs of age
  • •Underwent a low vision rehabilitation initial eye exam
  • •No more than 2 errors on cognitive on cognitive screening measure (SPBS)
  • •Must have access to telephone
  • •No significant hearing problems
  • •No significant communication problems
  • •Speaks fluent English

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

PST

干预措施: problem-solving training (Behavioral)

2

Sham Comparator

Attention Control

干预措施: sham intervention (Behavioral)

结局指标

主要结局

Center for Epidemiological Studies Depression Scale (CES-D)

时间窗: baseline, 3months, 6 months, 12 months, 24 months

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 (1)

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