Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000052437
Ethics application status
Approved
Date submitted
5/06/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Communication via Patient App for the Nonverbal in the ICU
Scientific title
Evaluation of a communication app in ICU patients who are nonverbal after head and neck cancer surgery
Secondary ID [1] 310606 0
None
Universal Trial Number (UTN)
Trial acronym
COMPANI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonverbal post surgery 331490 0
Head and Neck Cancer 334877 0
Condition category
Condition code
Physical Medicine / Rehabilitation 328223 328223 0 0
Speech therapy
Emergency medicine 328224 328224 0 0
Other emergency care
Cancer 328222 328222 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327015 0
Treatment: Devices
Comparator / control treatment
Conventional communication devices. During this 24 hour period only the standard communications aids are available for use ( pen, paper and laminated talkboards and letter boards). The iPad app is not able to be used for communication and they are not able to switch to use the iPad app prior to the 24 hour control being completed.
Control group
Active

Outcomes
Primary outcome [1] 336092 0
Comparison of patient overall preference (binary choice when presented with "which device did you prefer?") following app-assisted communication and conventional communication analysed using a proportions test. The patient preferences are entered into a secure electronic form hosted by 'google forms'.
Timepoint [1] 336092 0
48 hours post study commencement (both arms of crossover study completed)
Primary outcome [2] 339132 0
Comparison of composite modified Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) 2.0 scores (a validated augmentative and alternative communication (AAC) assessment tool) analysed via two-sided t-test
Timepoint [2] 339132 0
48 hours post study commencement (both arms of crossover study completed)
Secondary outcome [1] 438675 0
Assessment of app use duration reported as mean +/-SD. The data will be collected by assessing app analytics stored within the iPad.
Timepoint [1] 438675 0
Following completion of app assisted communication time period
Secondary outcome [2] 438674 0
Comparison of patient preference for communication of functional requirements (Binary choice to question "Which communication strategy was better to request for something that you needed (e.g., water, blanket, etc.?") following app-assisted communication and conventional communication analysed using a proportions test. The patient preferences are entered into a secure electronic form hosted by 'google forms'.
Timepoint [2] 438674 0
48 hours post study commencement (both arms of crossover study completed)
Secondary outcome [3] 426817 0
Comparison of patient preference for communication of pain (binary choice when presented with "Which communication strategy was better to request for pain relief?" ) following app-assisted communication and conventional communication analysed using a proportions test. The patient preferences are entered into a secure electronic form hosted by 'google forms'.
Timepoint [3] 426817 0
48 hours post study commencement (both arms of crossover study completed)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary objective is to determine the effect on participant satisfaction with communication following the introduction of YoDoc® iPad® app relative to conventional measures as measured by a modified QUEST 2.0 survey. The null and alternative hypotheses are as follows:
H0 : SASC = SCC
Ha : SASC not equal SCC
Where SASC and SCM are participant satisfaction with App Supported Communication (ASC) and Conventional Communication (CC) measures, respectively. Analysis will be performed via two-sided t-test and presented as a boxplot.
The Participant’s communication strategy preference (CC or ASC) is categorical data and will be analysed using proportions test. The secondary end-point of the duration of the app use is continuous numerical data available only during the ASC period, and will be reported as mean ±SD. Logistical regression will be used when comparing recorded categorical and continuous variables. This will be utilized when testing for the association between the duration that the app was used and the preference for app at the time of the exit survey. P values lower than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/02/2023
Date of last participant enrolment
Anticipated
1/02/2025
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
16
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25529 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 41351 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 314820 0
Self funded/Unfunded
Name [1] 314820 0
Country [1] 314820 0
Primary sponsor type
Individual
Name
Joshua Starr - Prince of Wales Hospital
Address
Country
Australia
Secondary sponsor category [1] 316810 0
Individual
Name [1] 316810 0
Sumesh Arora - Prince of Wales Hospital
Address [1] 316810 0
Country [1] 316810 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313825 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 313825 0
Ethics committee country [1] 313825 0
Australia
Date submitted for ethics approval [1] 313825 0
13/07/2022
Approval date [1] 313825 0
29/08/2022
Ethics approval number [1] 313825 0
Eth01320

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129466 0
Mr Joshua Starr
Address 129466 0
Prince of Wales Hospital, Botany Rd, Randwick, 2031, NSW
Country 129466 0
Australia
Phone 129466 0
+61 4 3423 8337
Fax 129466 0
Email 129466 0
[email protected]
Contact person for public queries
Name 129467 0
Dr Joshua Starr
Address 129467 0
Prince of Wales Hospital, Botany St, Randwick, 2031 NSW
Country 129467 0
Australia
Phone 129467 0
+61 2 9382 2222
Fax 129467 0
Email 129467 0
[email protected]
Contact person for scientific queries
Name 129468 0
Dr Joshua Starr
Address 129468 0
Prince of Wales Hospital, Botany St, Randwick, 2031 NSW
Country 129468 0
Australia
Phone 129468 0
+61 2 9322 2222
Fax 129468 0
Email 129468 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Permission not granted by all participants



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.