ANZCTR - Registration

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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]

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

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Human Genetics and Inherited Disorders

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]

Not applicable

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At time of interview

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Womens and Childrens Hospital - North Adelaide

Recruitment postcode(s) [1]

5006 - North Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Women's and Children's Hospital

Address [1]

Department of Respiratory and Sleep Medicine
72 King William Road
North Adelaide
SA 5006

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

4DMedical

Address [2]

Level 7 Melbourne Connect
700 Swanston Street
Melbourne,
Victoria, 3053

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Hospital Network Human Ethics Comittee

Ethics committee address [1]

72 King William Road
North Adelaide
SA 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/08/2023

Approval date [1]

22/03/2024

Ethics approval number [1]

Summary

Brief summary

For medical technology and advances to be utilised in clinical practice they need to be not only effective and safe but also acceptable to consumers. To achieve this, it is important to invite the users of health technologies, including patients, carers and clinicians to provide feedback on new and emerging technologies. 
To determine the opinions, motivations, barriers and potential uptake of new technologies for cystic fibrosis care we are inviting paediatric patients, their parents/carers and associated health care workers to provide their opinion on two emerging technologies: XV LVAS imaging and airway gene therapy. It is important to determine the opinions of paediatric patients as well as their care team as in cystic fibrosis lung health in the early years impacts lifelong health and wellbeing for these patients. Mitigation of barriers to existing and emerging health interventions in this group will have a lifelong impact on wellbeing, life expectancy and healthcare utilization. 
Subjects will be invited to participate in this study based on their experience in the XV Feasibility Study (Protocol No: WCH_XV_001, ACTRN12623000109606). During this study cystic fibrosis affected children were offered an XV LVAS scan which is compared to results of routine Lung Function testing to determine whether this technology is safe, effective and an appropriate addition to paediatric cystic fibrosis care. Those children and their care teams will be interviewed to determine their attitudes towards the new technology and also that of airway gene therapy which is under development. 
Subjects will be invited to participate in a one-hour semi-structured interview to discuss their lived or clinical experience of cystic fibrosis, XV LVAS scans and understanding of gene therapy. This will be complemented by limited demographic data collection and complimentary data extracted from the XV Feasibility Study (WCH_XV_001).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Matthew Brourton

Address

Department of Respiratory and Paediatric Medicine
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006

Country

Australia

Phone

+61 08 8161 7459

Fax

matthew.brourton@sa.gov.au

Contact person for public queries

Name

Matthew Brourton

Address

Department of Respiratory and Paediatric Medicine
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006

Country

Australia

Phone

+61 08 8161 7459

Fax

matthew.brourton@sa.gov.au

Contact person for scientific queries

Name

Jessica Phillips

Address

Department of Respiratory and Paediatric Medicine
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006

Country

Australia

Phone

+61 08 8161 9179

Fax

jessica.phillips2@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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