Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000490471p
Ethics application status
Submitted, not yet approved
Date submitted
28/04/2025
Date registered
20/05/2025
Date last updated
20/05/2025
Date data sharing statement initially provided
20/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Talking Scrubs: Supporting the first-person communication between clinicians and patients with communication disability.
Scientific title
Talking Scrubs: A study of the use of key communication icons on scrubs (and vest) to support communication between clinicians and patients with communication disability - a Phase 4 feasibility and efficacy trial
Secondary ID [1] 314247 0
Nil
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
communication disability 337166 0
Condition category
Condition code
Mental Health 333584 333584 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involves both patients and their health professionals of the participating health services to consent to be part of the study. For clinicians participating in the research, it will involve 2 hours of preliminary training in the use of the adapted scrubs and scrub vest. This involves the clinician becoming familiar with the protocols of using the scrubs. It will also require the participating clinician to practice their use of the scrubs with members of the research team who have communication disability. Once the clinician feels confident in how to use the scrubs and scrubs vest, they will be asked to use them with patient participants with communication disability. Before using the scrubs and vest both health professionals and their patients will be interviewed. Clinician and patient participant (dyads) will be interviewed by a researcher and invited to complete a survey before using the scrubs. This survey is used to measure how confident the participants are in communicating with each other. It will form a baseline of communication self-efficacy. The clinician and patient (dyads) will be interviewed using a combination of structured, semi structured, and open questions. The interviews will be video recorded. Participants with communication disability are welcome to include a trusted support or communication assistant to help them get their messages out, if required. The interviewer(s) are trained in augmentative and alternative communication (AAC) and are experienced in interviewing people with diverse and complex forms of disability.
The participant dyads will then be invited to use the scrubs in their health appointments which can be once only or over several sessions (over a period of up to 4 months). Participants can decide to provide feedback on one session of using the scrubs or over multiple sessions. When the participant dyad is ready to give feedback, they will be re-interviewed which will involve answering the same survey that was answered before the use of the scrubs. We anticipate a period of four to six months will be required for clinicians to wear and use the scrubs/vest but this can be extended up to a maximum of eight months should participants wish to continue. At the end of this timeframe the scrubs/vest will be withdrawn, however, replica communication boards will be provided to assist clinicians continue using AAC in their communication with patients. We anticipate patient participant time of involvement in the study will vary. It is possible that a patient participant involvement may only be a single appointment with a GP, where diagnosis and treatment is discussed without need for diagnostic screening or a follow up appointment. It is also possible that a patient may require several appointments before diagnosis can be completed and thus be involved in the study over a longer period. Clinician and ongoing patient participants will be invited to keep a journal/scrap book centred on the interviewer questions such as what it felt like to use the scrubs/vest to communicate. Journal recordings are optional. What worked well or did not work well. Ideas for improving the scrubs/vest. Patient participants who are not ongoing (i.e., their involvement in the study does not extend beyond one appointment) will not be invited to keep a journal but will be interviewed instead.
Please - see example of icons in attached document.

Intervention code [1] 330858 0
Diagnosis / Prognosis
Comparator / control treatment
No control group or similar.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341168 0
Feasibility of the scrubs/vest intervention for use across the diagnostic process.
Timepoint [1] 341168 0
For patient participants the timepoint is a brief interview with a researcher at baseline (prior to intervention) and upon completion of the diagnostic process which may conclude with one or more sessions and may involve onsite diagnostic screening such as blood tests with participant clinicians. For clinician participants the timepoint is a single interview at baseline (prior to intervention with any patients) but with journalled self-recorded responses to broad feasibility questions upon completion of the diagnostic process with individual patient participants with a final brief interview with clinician participants at the conclusion of the study
Secondary outcome [1] 447114 0
Efficacy of the individual SE:CD22 instrument will be analyzed as an extension of the validation process.
Timepoint [1] 447114 0
Dual points - at baseline and after final interview.
Secondary outcome [2] 446611 0
Efficacy of the scrubs/vest intervention for use across the diagnostic process.
Timepoint [2] 446611 0
The questionnaires are used at baseline and upon completion of the diagnostic process for patient participants. The questionnaires are used at baseline and upon completion of the diagnostic process for clinician participants.
Secondary outcome [3] 447532 0
Efficacy of the individual SE:CH18 instrument will be analyzed as an extension of the validation process.
Timepoint [3] 447532 0
Dual points - at baseline and after final interview.

Eligibility
Key inclusion criteria
• GPs providing diagnosis for patients with communication disability (people with a disability who cannot easily be understood using speech)
• Patients of the GPs who have communication disability receiving a diagnosis
• Flow-on, on-site, clinician colleagues of the GPs who will perform diagnostic screening services for the patient as requested by the GP e.g., participating onsite nurses or phlebotomists.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
• Patients where this is no diagnostic involvement/requirement.
• Flow-on diagnostic screening clinicians external to the site agency.
• Patients without communication disability such as those who can speak but not in English.

Study design
Purpose of the study
Diagnosis
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline and completion questionnaire analysis - SPSS:29

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2025
Actual
Date of last participant enrolment
Anticipated
6/04/2026
Actual
Date of last data collection
Anticipated
3/08/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318767 0
Self funded/Unfunded
Name [1] 318767 0
Country [1] 318767 0
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 321212 0
None
Name [1] 321212 0
Address [1] 321212 0
Country [1] 321212 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317377 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 317377 0
Ethics committee country [1] 317377 0
Australia
Date submitted for ethics approval [1] 317377 0
08/04/2025
Approval date [1] 317377 0
Ethics approval number [1] 317377 0

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

Contacts
Principal investigator
Name 140862 0
Dr Betty-Jean Dee-Price
Address 140862 0
University of South Australia 61-68 North Terrace Adelaide 5000 South Australia
Country 140862 0
Australia
Phone 140862 0
+61 0434192392
Fax 140862 0
Email 140862 0
[email protected]
Contact person for public queries
Name 140863 0
Betty-Jean Dee-Price
Address 140863 0
University of South Australia - 61-68 North Terrace Adelaide 5000 South Australia
Country 140863 0
Australia
Phone 140863 0
+61 0434192392
Fax 140863 0
Email 140863 0
[email protected]
Contact person for scientific queries
Name 140864 0
Betty-Jean Dee-Price
Address 140864 0
university of South Australia 61-68 North Terrace Adelaide 5000 South Australia
Country 140864 0
Australia
Phone 140864 0
+61 0434192392
Fax 140864 0
Email 140864 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• UniSA sponsored website contact (website is in initial stages of development). Please see our early-stage website. https://unisa.portals.in-part.com/686f4e87-d5de-460e-9a10-7847e7f8360f?utm_source=technologies&utm_medium=portal&utm_term=latest

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Other    Icon examples.pdf


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.