Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000930684
Ethics application status
Approved
Date submitted
9/08/2023
Date registered
29/08/2023
Date last updated
8/09/2024
Date data sharing statement initially provided
29/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring attitudes towards emerging technologies in a paediatric cystic fibrosis clinic: airway gene therapy and XV LVAS imaging
Scientific title
Exploring attitudes towards emerging technologies in a paediatric cystic fibrosis clinic: airway gene therapy and XV LVAS imaging
Secondary ID [1] 310025 0
WCH_XV_002
Universal Trial Number (UTN)
U1111-1296-4281
Trial acronym
XV Qualitative Study
Linked study record
ACTRN12623000109606
This study is a follow-up study, inviting only a sub-set of children who have participated in the parent study and their associated parents/carers and health care workers to participate. Data from the parent study will also be utilised in determining demographics of the children who participate in this sub-study as well as comparing the answers to a questionnaire in the parent study with the answers provided in the semi-structured interview conducted in this study

Health condition
Health condition(s) or problem(s) studied:
cystic fibrosis 330559 0
Condition category
Condition code
Respiratory 327399 327399 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 327400 327400 0 0
Cystic fibrosis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A single, Semi-structured Interview with an individual participant (plus carer) conducted online. This study is examining the experience of participants in Study ID ACTRN12623000109606, who have cystic fibrosis and elected to undergo the XV imaging scan. These participants, their parents/carers and associated medical personnel are being invited to interview about their experience with the new imaging techniques and also their views on airway gene therapy.
Three groups of participants are being invited to participate in this study. These include a selection of patients from the parent study ACTRN12623000109606, which involved children trialling a new imaging technique (XV LVAS scan). Children with cystic fibrosis who completed this scan will make up one group, their parents/guardians will make up a second group and finally health care workers including doctors, nurses, scientists who are involved in cystic fibrosis care will be asked for their opinions on the technologies. Namely XV LVAS scans and airway gene therapies.
A sub-set of participants from the parent study will be invited to consent to this interview study. The interview will occur after participation in the parent study, allowing participants to reflect on their experience. The interview will take approximately 1 hour for each participant ( 1 hour for child, 1 hour for a parent/carer, 1 hour for a health care worker).
Intervention code [1] 326449 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335270 0
Primary composite outcome: Opinions of families (child and parent/guardian who have experienced the use of the technology) expressed in the semi-structured interviews will be analysed for trends with regard to potential uptake, benefits and risks of XV LVAS scans and airway gene therapy.
Timepoint [1] 335270 0
At time of interview
Secondary outcome [1] 423683 0
Secondary composite outcome: Health care worker's (doctors, nurses, scientists who care for cystic fibrosis children) opinions expressed in the semi-structured interviews will be analysed for trends with regard to potential uptake, benefits and risks of XV LVAS scans and airway gene therapy.
Timepoint [1] 423683 0
At time of interview

Eligibility
Key inclusion criteria
Participants will be invited to take part in the study if they fall into one of three focus groups:
Group 1: Children who participated in XV Feasibility study (WCH_XV_001, ACTRN12623000109606) and additionally were:
• Diagnosed with cystic fibrosis
• Aged 6-18 years old at Consent
• Completed XV LVAS imaging
• Completed the Cystic Fibrosis Questionnaire – Revised (CFQ-R) for their age group (6 to 13 years old or 14 years old to adult)
Group 2: Parents of eligible children in Group 1 regardless of whether the child participates in this study.
Group 3: Health care workers (clinicians, nurses, scientists and support staff) involved in the care of child, adolescent and/or adult cystic fibrosis patients.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Demographic data will be described using means and standard deviations for each group of the study. Interview data will undergo Thematic Analysis to determine the themes and trends in the data and answer the research questions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
30
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25064 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 40727 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 314204 0
Hospital
Name [1] 314204 0
Women's and Children's Hospital
Country [1] 314204 0
Australia
Funding source category [2] 314207 0
Commercial sector/Industry
Name [2] 314207 0
4DMedical
Country [2] 314207 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
Department of Respiratory and Sleep Medicine
72 King William Road
North Adelaide
SA 5006
Country
Australia
Secondary sponsor category [1] 316129 0
None
Name [1] 316129 0
Address [1] 316129 0
Country [1] 316129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313330 0
Women's and Children's Hospital Network Human Ethics Comittee
Ethics committee address [1] 313330 0
Ethics committee country [1] 313330 0
Australia
Date submitted for ethics approval [1] 313330 0
08/08/2023
Approval date [1] 313330 0
22/03/2024
Ethics approval number [1] 313330 0

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

Contacts
Principal investigator
Name 127758 0
Dr Matthew Brourton
Address 127758 0
Department of Respiratory and Paediatric Medicine
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country 127758 0
Australia
Phone 127758 0
+61 08 8161 7459
Fax 127758 0
Email 127758 0
[email protected]
Contact person for public queries
Name 127759 0
Matthew Brourton
Address 127759 0
Department of Respiratory and Paediatric Medicine
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country 127759 0
Australia
Phone 127759 0
+61 08 8161 7459
Fax 127759 0
Email 127759 0
[email protected]
Contact person for scientific queries
Name 127760 0
Jessica Phillips
Address 127760 0
Department of Respiratory and Paediatric Medicine
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country 127760 0
Australia
Phone 127760 0
+61 08 8161 9179
Fax 127760 0
Email 127760 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
As this is a semi-structured interview, private personal opinions may be expressed which would be inappropriate to be shared at the transcript level.


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.