Problems With Access to Health CareNCT04393012
Providing Access to an Alternative Nurse Call
A study testing Provide alternative nurse call and communication device in people with Problems With Access to Health Care, run by Iowa Adaptive Technologies, Inc..
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Problems With Access to Health Care
- What is being tested?
- Provide alternative nurse call and communication device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 14 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Voxello - V-1, 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.
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.
- Conditions
- Problems With Access to Health Care
- Being tested
- Provide alternative nurse call and communication device
- Keywords
- alternative access, patient-provider communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provide alternative nurse call and communication deviceOther
Evaluate impact of providing access to the nurse call system and a speech generating device.
| Study group | Role | What they receive |
|---|---|---|
| Noddle Group | Experimental | Patients who received noddle to allow access to the nurse call system. Receives: Other: Provide alternative nurse call and communication device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exit Survey Responses
Patient and Nurse Exit Surveys
Measured: Completed on the 1 day the patient finished use of the device(s).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Apr 2016
- Primary completion31 Oct 2019
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problems With Access to Health CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Evaluation of impact
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa Adaptive Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Richard R Hurtig, Ph.D., Principal investigator, Iowa Adaptive Technologies Inc. (dba Voxello)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393012
- Sponsor's protocol ID
- Voxello V1
- Other IDs
- R44NR016406
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified survey results are stored and could be shared as Excel files
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voxello - V-1, Alternative Nurse Call
- ClinicalTrials.gov ID
- NCT04393012
- Acronym / sponsor ID
- Voxello V1
- Conditions
- Problems With Access to Health Care
- Keywords
- alternative access, patient-provider communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Iowa Adaptive Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluation of impact
| Arm | Type | Receives |
|---|---|---|
| Noddle Group | Experimental | Other: Provide alternative nurse call and communication devicePatients who received noddle to allow access to the nurse call system. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provide alternative nurse call and communication deviceEvaluate impact of providing access to the nurse call system and a speech generating device. | Other | Noddle Group |
Primary outcome
Exit Survey Responses
Time frame: Completed on the 1 day the patient finished use of the device(s).
Patient and Nurse Exit Surveys
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: No. De-identified survey results are stored and could be shared as Excel files
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard R Hurtig, Ph.D. principal investigator
Iowa Adaptive Technologies Inc. (dba Voxello)
Questions about this trial
What is this clinical trial studying?
A study testing Provide alternative nurse call and communication device in people with Problems With Access to Health Care, run by Iowa Adaptive Technologies, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exit Survey Responses (time frame: Completed on the 1 day the patient finished use of the device(s).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.