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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)
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Scientific title
Investigating Acceptability and Usage of Voice Banking for People Living with Motor Neurone Disease (MND)
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Secondary ID [1]
312566
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Motor Neurone Disease
334468
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Dysarthria
334469
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Anarthria
334470
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Condition category
Condition code
Neurological
331088
331088
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0
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Neurodegenerative diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
329120
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Not applicable
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Reported acceptability of voice banking process
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Assessment method [1]
338859
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Semi-structured dyadic interviews with people living with MND (plwMND) and their carers, using a specifically designed interview schedule.
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Timepoint [1]
338859
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At the time of the interview (cross sectional study).
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Primary outcome [2]
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Reported usage patterns of banked voice
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Assessment method [2]
338900
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Semi-structured dyadic interviews with people living with MND (plwMND) and their carers, using a specifically designed interview schedule.
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Timepoint [2]
338900
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At the time of the interview (cross sectional study).
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Primary outcome [3]
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Identification of clinician factors influencing acceptability of banked voice.
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Assessment method [3]
338901
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Results from dyadic interviews and focus groups with speech pathologists and allied health assistants from three Motor Neurone Disease Clinics, using a semi-structured interview schedule.
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Timepoint [3]
338901
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At the time of the interview and focus group (cross sectional study).
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Secondary outcome [1]
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Identification of clinician factors influencing usage of banked voice. [additional primary outcome]
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Assessment method [1]
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Results from dyadic interviews and focus groups with speech pathologists and allied health assistants from three Motor Neurone Disease Clinics, using a semi-structured interview schedule.
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Timepoint [1]
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At the time of the interview and focus group (cross sectional study).
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Secondary outcome [2]
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Reported differences in acceptability of voice banking in different populations of plwMND.
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Assessment method [2]
438622
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Semi-structured dyadic interviews with people living with MND (plwMND) and their carers, using a specifically designed interview schedule.
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Timepoint [2]
438622
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After all semi-structured interviews with plwMND have been conducted.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
Psychosocial
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
29/08/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
317037
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University
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Name [1]
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La Trobe University
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Address [1]
317037
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Country [1]
317037
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Australia
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Funding source category [2]
317194
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Hospital
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Name [2]
317194
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Calvary Health Care Bethlehem
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Address [2]
317194
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Country [2]
317194
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Australia
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Primary sponsor type
Individual
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Name
Dr Lillian Krikheli
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Address
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Country
Australia
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Secondary sponsor category [1]
319284
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Hospital
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Name [1]
319284
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Calvary Health Care Bethlehem, VIC
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Address [1]
319284
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Country [1]
319284
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315749
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Calvary Health Care Bethlehem – Research & Ethics Committee
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Ethics committee address [1]
315749
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https://www.calvarycare.org.au/public-hospital-bethlehem/services-and-clinics/research/
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Ethics committee country [1]
315749
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Australia
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Date submitted for ethics approval [1]
315749
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19/07/2024
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Approval date [1]
315749
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20/08/2024
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Ethics approval number [1]
315749
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Lillian Krikheli
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Address
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Discipline of Speech Pathology, Department of Community and Clinical Health, School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Victoria, 3086
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Country
135690
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Australia
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Phone
135690
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+61 3 9479 1033
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Fax
135690
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Email
135690
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[email protected]
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Contact person for public queries
Name
135691
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Lillian Krikheli
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Address
135691
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Discipline of Speech Pathology, Department of Community and Clinical Health, School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Victoria, 3086
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Country
135691
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Australia
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Phone
135691
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+61 3 9479 1033
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Fax
135691
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Email
135691
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[email protected]
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Contact person for scientific queries
Name
135692
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Lillian Krikheli
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Address
135692
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Discipline of Speech Pathology, Department of Community and Clinical Health, School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Victoria, 3086
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Country
135692
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Australia
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Phone
135692
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+61 3 9479 1033
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Fax
135692
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Email
135692
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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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.
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