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临床试验/NCT01109576
NCT01109576已完成早期 1 期

Pilot Study: Self Management Groups for Veterans With Dual Sensory Loss

US Department of Veterans Affairs4 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
13
试验地点
4
主要终点
Change in Profile of Mood States Total Score.

研究概览

简要总结

This is a pilot study of workshops to help Veterans with both vision and hearing loss live a happier, fuller and less stressful life. The results will be used to guide the development of a large scale clinical trial.

详细描述

This pilot study will enrolled 13 Veterans with Dual Sensory Loss (DSL), age 65 to over 89. The project headquarters in the Portland Oregon Veterans Affairs Medical Center will be tasked with the development of the workshops and writing of a Curriculum and Procedures Manual. The Atlanta VAMC research collaborators enrolled the 13 Veterans. Staff turnover reduced time available for enrollment and data collection. We therefore eliminated the original comparison group design and this study had only one experimental intervention arm and no control intervention or other arm. Veterans were chronologically enrolled who responded to recruitment letters and who passed telephone and onsite screening. The intervention consisted of six weekly two hour workshops providing information, skills training and exercises about self-managing DSL effects on daily life. Preliminary effectiveness data was collected and analyzed, and a large scale clinical trial will be proposed as a followup to explore the efficacy of this management approach. This study data tracked pre and post intervention within subject changes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Vision loss > 20/70 better eye;
  • Hearing loss > 40 decibels better ear;
  • Cognition Within Normal Limits (WNL);
  • No behavioral flag or psychiatric diagnosis;
  • Documented psychosocial restrictions secondary to vision and hearing loss

排除标准

  • Vision and/or hearing can be corrected by surgical or pharmacological treatment;
  • Requires use of sign language interpreter

结局指标

主要结局

Change in Profile of Mood States Total Score.

时间窗: Change in Profile of Mood States Score from Baseline to 8 Weeks

The change in Profile of Mood States total score is defined as the 8 week follow-up total score minus the baseline POMS total score. The scale measures change in mood states before and after treatment. The change score can range from -232 to 232, with negative values indicating greater reduction in emotional distress.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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Workshops for Veterans With Vision and Hearing Loss | 临床试验