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OpenTrials
Completed

NCT Number: NCT04393012

Providing Access to an Alternative Nurse Call

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.

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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Provide alternative nurse call and communication device

Other

Evaluate impact of providing access to the nurse call system and a speech generating device.

Primary outcomes

  1. Exit Survey Responses

    Time frame: Completed on the 1 day the patient finished use of the device(s).

    Patient and Nurse Exit Surveys

Sponsors and collaborators

Lead sponsor

Iowa Adaptive Technologies, Inc.

Industry

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Voxello - V-1, Alternative Nurse Call

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
May 19, 2020
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.