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Communication via Patient App for the Nonverbal in the ICU

Evaluation of a communication app in ICU patients who are nonverbal after head and neck cancer surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000052437
Acronym
COMPANI
Enrollment
4
Registered
2025-01-20
Start date
2023-02-24
Completion date
2025-02-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to compare the use of an iPad-based app (YoDoc®, Version 2.2) to the use of conventional communication devices in communication by nonverbal post-head and neck cancer surgical patients in a crossover design. Who is it for? You may be eligible for this study if you are a male or female aged 18 to 80 years old, planned for HNC surgery, and have a strong likelihood of being nonverbal post-procedure. You must also be admitted to ICU after surgery and without any mental or physical disability which prevent the use of iPad based app. Study details The participants will use conventional communication devices (e.g., pen & paper) during one study period, and an iPad-based app (YoDoc®, Version 2.2) during the other period. The comparison will be made using a modified QUEST 2.0 survey and an exit survey. It is hoped that information provided by this study will further medical knowledge and may improve future treatment of patients after head and neck surgery who are unable to speak after head and neck surgery. It is also likely that the iPad® based app may be of use to other group of patients who are unable to speak, e.g. those who require breathing tube & breathing machine; after a stroke, etc.

Interventions

The study will evaluate communication by nonverbal post-head and neck cancer surgical patients in a crossover design. The participants will use conventional communication devices (e.g., pen & paper) during one 24 hour study period, and an iPad-based app (YoDoc®, Version 2.2) during the 24 hour period. Once the participant is awake and alert post operatively the two study periods occur back to back over 48 hours, the participant is randomised as to which study period they start with (thus varying

The study will evaluate communication by nonverbal post-head and neck cancer surgical patients in a crossover design. The participants will use conventional communication devices (e.g., pen & paper) during one 24 hour study period, and an iPad-based app (YoDoc®, Version 2.2) during the 24 hour period. Once the participant is awake and alert post operatively the two study periods occur back to back over 48 hours, the participant is randomised as to which study period they start with (thus varying the initial communication device used). The comparison will be made using a modified QUEST 2.0 survey and an exit survey. At the time of consenting for the study an orientation and training session with the app is undertaken. When the study period commences that utilises the app, re-orientation is performed and app usage data is collected during the 24 hour period. The app is a virtual ICU-specific talkboard with annotated pictograms. Pressing on the pictogram (glass of water, toothbrush, TV remote etc.) results in 'voicing' of the annotation. This may allow a patient to initiate a conversation or request care without the prompting of a health care provider. It also has features which allow for detailed description of pain, as well a blank screen on which words can be written with a stylus. These features allow for the app to be used despite reduced dexterity or muscle power as is common in critically unwell patients. The participant is introduced to the app by a study member (doctor or nurse) following the consenting process. This involves orientation regarding the feature of the app and simulated use with the available accessories (stand, keyboard, stylus) and takes approximately 5 minutes.

Sponsors

Joshua Starr - Prince of Wales Hospital
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

• Planned Head and Neck Cancer (HNC) surgery, and strong likelihood of being nonverbal post procedure. This may be due to a tracheostomy, or because of procedures like hemiglossectomy. The HNC surgeon and Speech Pathologist who are a part of the study group will advise on which patients will not be able to talk in the early post-operative period. • Planned for admission to ICU post-operatively • Understand spoken and written English as judged by study personnel • Undergo Mini-Cog© testing (For evaluation of cognition) and pass

Exclusion criteria

• Diagnosis of cognitive impairment or DSM-V mental illness predicted to impair communication • Baseline use of AAC device for primary communication • Significant upper limb motor or sensory impairment (e.g. after spinal cord injury) • Non-use of an Android® or iOS® compatible smart phone or tablet-device in their day-to-day life in the preoperative period.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026