Providing Access to an Alternative Nurse Call

Problems With Access to Health Care Clinical Trial

Official title:

Voxello - V-1, Alternative Nurse Call

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04393012
• Other study ID #: Voxello V1
• Secondary ID: R44NR016406
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: January 14, 2020

Study information

• Verified date: May 2020
• Source: Iowa Adaptive Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 14, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

1. Patients must be conscious, able to produce an intentional gesture and appropriately respond to yes/no questions.

2. 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:

1. Patients who are sedated or unconscious (patients who are sedated for limited time may be considered).

2. Can access the nurse call and speak without other assistance

Related Conditions & MeSH terms

• Problems With Access to Health Care

Intervention

Other:
• Provide alternative nurse call and communication device
Evaluate impact of providing access to the nurse call system and a speech generating device.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Iowa Adaptive Technologies, Inc.	National Institute of Nursing Research (NINR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exit Survey Responses	Patient and Nurse Exit Surveys	Completed on the 1 day the patient finished use of the device(s).

External Links

•   Link to journal