CClinicalTrials.gg
CompletedNCT04393012Updated May 19, 2020

Providing Access to an Alternative Nurse Call

An interventional study of Provide alternative nurse call and communication device in Problems With Access to Health Care, sponsored by Iowa Adaptive Technologies, Inc.. Completed. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2020-05-19.

Sponsored by Iowa Adaptive Technologies, Inc. · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Apr 2016, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Not applicable
Ages
7 Years and older
Sex
All
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Study 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.

Read the detailed 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.

02

Conditions studied

  • Problems With Access to Health Care

Keywords

  • alternative access
  • patient-provider communication
03

In context

Lead sponsor

This is the only study on the registry with Iowa Adaptive Technologies, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    Noddle Group

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

    Other: Provide alternative nurse call and communication device

Interventions

  • OtherProvide alternative nurse call and communication device

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

06

What researchers measure

Primary outcomes

  1. Exit Survey Responses

    Patient and Nurse Exit Surveys

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Related links

Individual participant data

Plan to share: No — De-identified survey results are stored and could be shared as Excel files

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04393012
Lead sponsor
Iowa Adaptive Technologies, Inc.
Collaborators
National Institute of Nursing Research (NINR)
Responsible party
Sponsor
First posted
May 19, 2020
Start date
Apr 1, 2016
Primary completion
Oct 31, 2019
Completion
Jan 14, 2020
Last update
May 19, 2020

Study contacts

Richard R Hurtig, Ph.D.
principal investigator · Iowa Adaptive Technologies Inc. (dba Voxello)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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