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临床试验/NCT04393012
NCT04393012已完成不适用

Voxello - V-1, Alternative Nurse Call

Iowa Adaptive Technologies, Inc.0 个研究点目标入组 69 人开始时间: 2016年4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
发起方
入组人数
69
主要终点
Exit Survey Responses

研究概览

简要总结

To address the needs of the many patients who cannot access the standard nurse call systems Iowa Adaptive Technologies has developed the Noddle, a smart switch that can take the smallest intentional gesture a patient can make (e.g. tongue click, wink) and allow the patient to access the nurse call system and control a speech-generating device. This study will assess how patients and their nurses as well as family members perceive the impact of having a device that would allow them to summon the nurse and to be able to effectively communicate. Patients will be provided a Noddle and will be free to use it as much or a little as they like during their hospitalization. Patients will either use the Noddle just to access the nurse call system or they will use it to access the nurse call system and a speech-generating device. Patients, nurses and family members will be asked to complete an exit questionnaire prior to discharge from the hospital.

详细描述

The study will evaluate the responses of patients, nurses and family members to the use of the Noddle switch to enable the patients to access the nurse call system and a speech generating device. Patients who cannot access the standard nurse call and who may not be able to speak due to mechanical ventilation will be recruited to the study and provided the opportunity to use the Noddle switch as long as they want while they are hospitalized at UIHC. Prior to their discharge or when they no longer need or want to use the Noddle switch, they along with their nurses and family members (if present) will be asked to complete a survey to assess their ability to effectively communicate. The data from the study participants will be compared to data from two groups of patients from a previous study who were either able to or unable to access the nurse call system and communicate with caregivers.

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
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients must be conscious, able to produce an intentional gesture and appropriately respond to yes/no questions.
  • •Patients must be severely limited in their mobility and unable to access the nurse call system and/or must be unable to use normal modes of oral and written modes of communication.

排除标准

  • •Patients who are sedated or unconscious (patients who are sedated for limited time may be considered).
  • •Can access the nurse call and speak without other assistance

研究组 & 干预措施

Noddle Group

Experimental

Patients who received noddle to allow access to the nurse call system.

干预措施: Provide alternative nurse call and communication device (Other)

结局指标

主要结局

Exit Survey Responses

时间窗: Completed on the 1 day the patient finished use of the device(s).

Patient and Nurse Exit Surveys

次要结局

未报告次要终点

研究者

发起方
Iowa Adaptive Technologies, Inc.
申办方类型
Industry
责任方
Sponsor

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