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Trial registered on ANZCTR


Registration number
ACTRN12624001020572
Ethics application status
Approved
Date submitted
24/07/2024
Date registered
22/08/2024
Date last updated
22/08/2024
Date data sharing statement initially provided
22/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating Acceptability and Usage of Voice Banking for People Living with Motor Neurone Disease (MND)
Scientific title
Investigating Acceptability and Usage of Voice Banking for People Living with Motor Neurone Disease (MND)
Secondary ID [1] 312566 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor Neurone Disease 334468 0
Dysarthria 334469 0
Anarthria 334470 0
Condition category
Condition code
Neurological 331088 331088 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Project consists of two parts.

(1) Semi-structured interviews:
A total of 15 people living with Motor Neurone Disease (plwMND) and their carers will attend a dyadic interview and be allocated to one of three study arms based on the type of communication mode they use:
- Five plwMND (+carers) who have banked their voice, still use verbal communication and do not require a speech generating device yet
- Five plwMND (+carers) who are dysarthric, have banked their voice and do choose to use a speech generating device with their banked voice
- Five plwMND (+carers) who are dysarthric, have banked their voice and do not choose to use a speech generating device with their banked voice

Using quota sampling, researchers will ensure there is adequate within-group representation of MND onset-types and ages. Interviews will either be conducted in-person or via Zoom (participants can nominate a preference based on their location). A semi-structured interview schedule will be used with questions that relate to experiences and affective attitudes of plwMND when receiving informational counselling and hearing/utilising their synthetic voice.

All participant groups in this phase will be given the interview schedule in advance to provide an opportunity to prepare responses; advantageous for plwMND who are anarthric and do not have an efficient mode of communication. Composing words, sentences and messages through alternative communication system is typically slower than natural speech production. Giving participants an opportunity to pre-prepare responses will allow more time in the sessions to ask follow up questions to explore themes raised by the participants. The anticipated time for interviews will be 45-60 minutes.Sessions will be audio/video recorded depending on the format chosen by the participant.

Questions for all participants will include asking them to describe their experiences with the voice banking process from start to completion, what supports they received during the voice banking process, how they feel about the sound and quality of the banked voice compared to their original natural voice, how acceptable is the banked voice for use in a speech generating device, and to describe how the banked voice is used (or how they anticipated using it). For the group that choose not to use their banked voice, they will be also be asked why they they made the decision not to use the banked voice after recording.

PlwMND will be given the opportunity to provide member checking (also known as participant or respondent validation), to explore the credibility of results. The transcript will be returned to participants to check for accuracy and resonance with their experiences as a way of having control over the final product. Once finalised, identifiable information will be redacted to commence analysis.


(2) Focus groups with speech pathologists who support plwMND:
Two focus groups will be completed with speech pathology teams who provide support to plwMND to complete and use voice banking.
Speech pathologists and allied health assistants from three Motor Neurone Disease Clinics in Victoria will be invited to participate in focus groups to investigate clinician factors that may be impacting acceptability and usage of a banked voice for a person living with MND. The anticipated time for focus groups will be 60 minutes.

Focus group 1: Speech pathologists employed at Calvary Health Care Bethlehem who utilise the newly trialled clinic model (initiated in earlier phases of the larger project). This will be conducted in hybrid mode with people face-to-face and off-site.

Focus group 2: Speech pathologists at (1) Northern Health and (2) Barwon Health MND clinics who do not employ a formal voice banking clinic model.

Speech pathologists will be asked to describe the process of supporting a plwMND to bank their voice from start to finish, how they learnt to support a plwMND to complete voice banking, what are common queries or comments that they receive from PlwMND and their
carers about the sound and quality of the banked voice (and how do they address
these?),. Additionally, they will be asked questions about the degree speech pathologists may influence or support the acceptability of a banked voice to plwMND and their families and whether speech pathologists influence or support the usage patterns of a
banked voice to plwMND and their families.

A semi-structured interview schedule will be used with questions that relate to how clinicians support plwMND when providing informational counselling, recording and facilitate utilisation of their synthetic voice.
Intervention code [1] 329120 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338859 0
Reported acceptability of voice banking process
Timepoint [1] 338859 0
At the time of the interview (cross sectional study).
Primary outcome [2] 338900 0
Reported usage patterns of banked voice
Timepoint [2] 338900 0
At the time of the interview (cross sectional study).
Primary outcome [3] 338901 0
Identification of clinician factors influencing acceptability of banked voice.
Timepoint [3] 338901 0
At the time of the interview and focus group (cross sectional study).
Secondary outcome [1] 437699 0
Identification of clinician factors influencing usage of banked voice. [additional primary outcome]
Timepoint [1] 437699 0
At the time of the interview and focus group (cross sectional study).
Secondary outcome [2] 438622 0
Reported differences in acceptability of voice banking in different populations of plwMND.
Timepoint [2] 438622 0
After all semi-structured interviews with plwMND have been conducted.

Eligibility
Key inclusion criteria
Study 1:
The Statewide Progressive Neurological Diseases Service (SPNDS) at Calvary Health Care Bethlehem (CHCB) provides specialist care for approximately 70% of plwMND across Victoria, Australia. Eligible plwMND will be identified using an existing Calvary Health Care Bethlehem voice banking clinical database to contact patients with MND who have already completed voice banking (and who consent to be approached for research as documented in the clinical intake form).


Study 2:
Speech pathologists and allied health assistants from three Motor Neurone Disease Clinics in Victoria (Calvary Health Care Bethlehem, Northern Health and Barwon Health) will be contacted via email by Calvary-based co-investigators to join the study. Former employees from Calvary Health Care Bethlehem (who were active clinicians in the voice banking clinic program during the previous trial period) will also be invited to ensure that an accurate representation of practices are captured.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Study 1:
- PlwMND not consenting to be contacted for research in SPNDS clinical intake form
- PlwMND with accompanying diagnosed Frontotemporal dementia (FTD). Cognitive change is common in MND and is not an exclusion criterion.
- Significant psychiatric disorder.


Study 2:
Speech pathologists and allied health assistants who have not completed any one of the following activities in the preceding 12 months to participation:
- providing informational counselling to people living with MND,
- voice banking recording, or
- download and set up to a speech generating device.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Thematic analysis of both focus group transcriptions will be conducted by the research team to identify factors impacting acceptability of voice banking interventions and any similarities and differences between groups.

Data analysis will consist of a thematic analysis. Organisation of data, coding and identification of themes will be completed using Braun and Clarke’s (2006) framework for thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317037 0
University
Name [1] 317037 0
La Trobe University
Country [1] 317037 0
Australia
Funding source category [2] 317194 0
Hospital
Name [2] 317194 0
Calvary Health Care Bethlehem
Country [2] 317194 0
Australia
Primary sponsor type
Individual
Name
Dr Lillian Krikheli
Address
Country
Australia
Secondary sponsor category [1] 319284 0
Hospital
Name [1] 319284 0
Calvary Health Care Bethlehem, VIC
Address [1] 319284 0
Country [1] 319284 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315749 0
Calvary Health Care Bethlehem – Research & Ethics Committee
Ethics committee address [1] 315749 0
https://www.calvarycare.org.au/public-hospital-bethlehem/services-and-clinics/research/
Ethics committee country [1] 315749 0
Australia
Date submitted for ethics approval [1] 315749 0
19/07/2024
Approval date [1] 315749 0
20/08/2024
Ethics approval number [1] 315749 0

Summary
Brief summary
Previous studies with plwMND indicate that using a banked voice on a device has benefits in maintaining identity and preserving social networks (Cave & Bloch, 2021). However, in a recent study, 26% of plwMND who had banked their voices were not satisfied with their output voice (unpublished; Krikheli & Jackson, 2023).

This novel study aims to investigate the factors relating to:
- the acceptability of undertaking the voice banking process at disease onset, and
- downloading and using banked voice output on speech generating devices

This project will contribute to our understanding of how clinicians and voice banking services can improve acceptability of voice banking technology for plwMND and their carers, leading to more informed informational counselling approaches, improved therapeutic interventions and increased uptake.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135690 0
Dr Lillian Krikheli
Address 135690 0
Discipline of Speech Pathology, Department of Community and Clinical Health, School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Victoria, 3086
Country 135690 0
Australia
Phone 135690 0
+61 3 9479 1033
Fax 135690 0
Email 135690 0
[email protected]
Contact person for public queries
Name 135691 0
Lillian Krikheli
Address 135691 0
Discipline of Speech Pathology, Department of Community and Clinical Health, School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Victoria, 3086
Country 135691 0
Australia
Phone 135691 0
+61 3 9479 1033
Fax 135691 0
Email 135691 0
[email protected]
Contact person for scientific queries
Name 135692 0
Lillian Krikheli
Address 135692 0
Discipline of Speech Pathology, Department of Community and Clinical Health, School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Victoria, 3086
Country 135692 0
Australia
Phone 135692 0
+61 3 9479 1033
Fax 135692 0
Email 135692 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the small sample size and the vulnerability of participants living with Motor Neurone Disease (MND), individual participant data from transcripts will not be shared to ensure the privacy and confidentiality of sensitive health information. Staff group transcripts will also not be shared to protect the confidentiality and anonymity of the small group of healthcare professionals involved, ensuring a safe and secure environment for open and honest discussion. Redacted/anonymised quotes from all groups will be disseminated in subsequent publications.


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.