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临床试验/NCT02102958
NCT02102958已完成不适用

Nonvisual Foot Examination for People With Diabetes and Visual Impairment

Case Western Reserve University2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
Frequency of foot examination at home

研究概览

简要总结

Because people who have both diabetes and visual impairment have high risk for foot problems, prevention of ulcers and amputation is a high priority. Usual care in diabetes self-management education (DSME) is to teach them to seek sighted assistance for regular foot examination, yet clinical experience suggests that this advice is seldom heeded. One possible solution is to teach use of the nonvisual senses of touch and smell for a systematic, thorough foot self-examination. The purpose of this pilot study was to compare the efficacy, acceptability, and feasibility of nonvisual foot examination with usual care (examination of the visually impaired person's feet by a sighted family member or friend).

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
Single (Participant)

入排标准

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

入选标准

  • over age 18
  • diagnosed with either type 1 or type 2 diabetes
  • stated they had visual impairment

排除标准

  • unable to pass a brief decisional capacity test
  • had a score above 80 on the near vision scale of the National Eye Institute Visual Functioning Questionnaire
  • had bilateral lower extremity amputations
  • by self-report were unable to sense light touch on two or more fingers or either hand

结局指标

主要结局

Frequency of foot examination at home

时间窗: 6 months

number of times that the enrolled participant or someone else examined the person's feet at home during the study period

次要结局

  • New foot problems discovered at home(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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