NCT04393012

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

3.6 years

First QC Date

May 11, 2020

Last Update Submit

May 18, 2020

Conditions

Keywords

alternative accesspatient-provider communication

Outcome Measures

Primary Outcomes (1)

  • Exit Survey Responses

    Patient and Nurse Exit Surveys

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

Study Arms (1)

Noddle Group

EXPERIMENTAL

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

Other: Provide alternative nurse call and communication device

Interventions

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

Noddle Group

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Richard R Hurtig, Ph.D.

    Iowa Adaptive Technologies Inc. (dba Voxello)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Evaluation of impact
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 19, 2020

Study Start

April 1, 2016

Primary Completion

October 31, 2019

Study Completion

January 14, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

De-identified survey results are stored and could be shared as Excel files