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Trial registered on ANZCTR


Registration number
ACTRN12620000084987
Ethics application status
Approved
Date submitted
3/01/2020
Date registered
3/02/2020
Date last updated
24/02/2020
Date data sharing statement initially provided
3/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Cystic Fibrosis Telehealth Virtual Clinic Initiative
Scientific title
Cystic Fibrosis Telehealth Virtual Clinic Initiative – A Prospective Study on Patients living in Regional and Metropolitan, NSW and/or colonised with Multi-Resistant Microbiota examining experience of care.
Secondary ID [1] 299825 0
None
Universal Trial Number (UTN)
U1111-1243-6651
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 315208 0
Condition category
Condition code
Respiratory 313526 313526 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 314303 314303 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot/feasibility study comparing the routine multidisciplinary CF clinic structure with a hybrid model including Telehealth virtual clinics over a period of 1 year. Data will be prospectively collected from 3 CF patient cohorts within the Royal Prince Alfred Hospital CF Clinic:
a. Patients living in regional NSW
b. Patients living in metropolitan NSW, 15km away from the RPA CF centre
c. Patients colonised with multi-resistant bacteria

The Telehealth group will receive a portable spirometer to be used at subsequent telehealth visits and instructions on how to use the device. This will be provided at their initial (recruitment) visit. Patients will be advised that they will have access to CF Telehealth virtual clinics over the following 12 months. International CF guidelines recommend attendance at CF clinic every 2-3 months. At least 1 of their routine clinic visits during this time will need to occur in hospital. All other visits can be via telehealth.

Further information:
Telehealth sessions will use a secure online pexip platform made available through Sydney local health district.

Duration of sessions for vary between 1-2 hours to incorporate usual clinical care involving the multidisciplinary CF team (including physicians, nurses, physiotherapists, dietitian and sub-specialists). Clinics will occur every 3 months as recommended by national and international CF guidelines. Telehealth can be performed by any member of the MDT CF service.

Telehealth sessions will replace some routine face to face clinic visits. Usual discussions that occur within face to face CF clinic visits will occur via telehealth.

Patients will need to use the spirometry apps during telehealth clinic visits and will need to connect to the online platform for their telehealth visit.

Patients will need to email portable spirometry results prior to their visits, and will need to be observed performing spirometry during their telehealth visit.

This is a prospective controlled (non-randomised) study. Patients who agree to participate will be consecutively enrolled in the telehealth arm. Patients who are not assigned to telehealth will be invited to partake in the study as control subjects (usual clinic based care) and asked to provide feedback on the current face to face health delivery model in the clinic.

This intervention will replace some routine clinic visits. Patients will be asked to attend 2 face to face appointments (every 6 months). All other visits can be done via telehealth.

We will monitor clinic attendance over this one year period. Email reminders will be used if results are not sent, followed by phone calls.

The AirMD spirometry app will be used, which is freely available in the app store on most smartphones. Results of their spirometry will only be available on their phone and not stored in a cloud. Participants set up their profile on the app and will save data locally only ie on their phone. They can share results with us by sending a pdf copy of their results. Patients are free to use their spirometers any time they feel it is necessary but should send spirometry results before their telehealth visit. Spirometry will be performed again during their telehealth visit.
Intervention code [1] 316445 0
Treatment: Other
Comparator / control treatment
Non Telehealth arm will be asked to complete a similar set of questionnaires evaluating patient satisfaction with the existing healthcare delivery model within the CF clinic as well as questions on overall well-being.
The control group will receive standard care/routine face to face clinic care involving the multidisciplinary team.
Control group
Active

Outcomes
Primary outcome [1] 322406 0
Patient Experience of Care Survey (obtained from the CF foundation and is a validated tool to assess CF patient experience of care in the clinic setting).
Timepoint [1] 322406 0
Baseline, 6 months (primary endpoint) and 12 months.
Secondary outcome [1] 378378 0
a) SLHD Patient satisfaction survey - online survey
This survey is designed for this district to evaluate service delivery in all specialities.


Timepoint [1] 378378 0
Baseline, 6 and 12 months
Secondary outcome [2] 378998 0
b) CQOLCF Scale - online survey
Caregiver quality of life survey
Timepoint [2] 378998 0
6 and 12 months
Secondary outcome [3] 378999 0
c) CFQ-R - online survey
Validated survey to assess CF participant quality of life
Timepoint [3] 378999 0
Baseline, 6 and 12 months
Secondary outcome [4] 379000 0
d) Assessment of patient time commitment - online survey
To assess duration of time for patient to travel to and attend clinic
This was designed specifically for this study
Timepoint [4] 379000 0
Baseline, 6 and 12 months
Secondary outcome [5] 379001 0
e) Telehealth satisfaction scale - online survey
Timepoint [5] 379001 0
6 and 12 months
Secondary outcome [6] 379002 0
f) RPA CF specific telehealth satisfaction survey - online survey
This was designed specifically for this study
Timepoint [6] 379002 0
6 and 12 months
Secondary outcome [7] 379003 0
h) Compare home spirometer results (technique) when performed with and without supervision by a lung function lab staff member - clinical encounter just prior to and during telehealth appointment
Reliability of at home participant technique
Timepoint [7] 379003 0
6 and 12 months
Secondary outcome [8] 379375 0
Cost assessment for a patient to attend clinic
To assess overall cost of attending clinic
This was designed specifically for this study
Timepoint [8] 379375 0
baseline, 6 and 12 months

Eligibility
Key inclusion criteria
All patients within the CF clinic will be invited to participate if they live more than 15km away from the hospital. All patients partaking in this trial will have cystic fibrosis.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Patients without a reliable internet connection at home, work or at their GP practice (applicable for the hybrid CF in-hospital and Telehealth initiative).
b. Unstable patients requiring frequent hospital admissions, including hospital in the home, over the past year (> 4 admissions per year)
c. No behavioural or cognitive disabilities
d. No compatible smart phone capable of working with portable spirometer (applicable for Telehealth arm)

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15571 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 28945 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 304287 0
Government body
Name [1] 304287 0
Sydney Local Health District
Address [1] 304287 0
Level 11, KGV Building
Missenden Road, Camperdown, NSW 2050
Country [1] 304287 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital Cystic Fibrosis Service
Address
Level 11, KGV Building
Missenden Road, Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 304530 0
None
Name [1] 304530 0
N/A
Address [1] 304530 0
N/A
Country [1] 304530 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304744 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 304744 0
Research Ethics and Governance Office (REGO)
RPAH Medical Centre
Suite 210A, Level 2
100 Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 304744 0
Australia
Date submitted for ethics approval [1] 304744 0
Approval date [1] 304744 0
01/11/2019
Ethics approval number [1] 304744 0
X19-0339 & 2019/ETH12749

Summary
Brief summary
This study will evaluate an updated health care delivery model for patients with Cystic Fibrosis by incorporating virtual health/telehealth clinics. For patients in the telehealth arm, clinic visits may occur at home, work or at their local GP practice. This will replace in-hospital clinic visits. Patients in this arm however will need to attend at least one in-hospital clinic visit over a 12 month period. Spirometry will be performed at home using a portable spirometer. Patient satisfaction and well-being questionnaires will need to be completed at baseline, 6 and 12 months.

Patients in the non-telehealth arm will need to complete similar questionnaires at baseline, 6 and 12 months. Patients in the latter arm will continue to attend in-hospital clinic visits every 3 months.

Three groups of patients will be recruited for this study;
a. Patients living in regional NSW
b. Patients living in metropolitan NSW, 15km away from the RPA CF centre
c. Patients colonised with multi-resistant bacteria
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98058 0
Ms Jody Bell
Address 98058 0
Royal Prince Alfred, Level 11, KGV Building Missenden Road, Camperdown, NSW 2050
Country 98058 0
Australia
Phone 98058 0
+61 2 9515 4970
Fax 98058 0
Email 98058 0
jody.bell@health.nsw.gov.au
Contact person for public queries
Name 98059 0
Ms Jody Bell
Address 98059 0
Royal Prince Alfred, Level 11, KGV Building Missenden Road, Camperdown, NSW 2050
Country 98059 0
Australia
Phone 98059 0
+61 2 9515 4970
Fax 98059 0
Email 98059 0
jody.bell@health.nsw.gov.au
Contact person for scientific queries
Name 98060 0
Dr Sheila Sivam
Address 98060 0
Royal Prince Alfred, Level 11, KGV Building Missenden Road, Camperdown, NSW 2050
Country 98060 0
Australia
Phone 98060 0
+61 2 9515 8195
Fax 98060 0
Email 98060 0
sheila.sivam@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results