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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

22/12/2021

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]

None

Universal Trial Number (UTN)

U1111-1243-6651

Trial acronym

Linked study record

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

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]

Treatment: Other

Comparator / control treatment

Due to the global pandemic all patients were offered the option of telehealth via video conferencing. At the beginning of recruitment participates where also recruited for the control arm but with the pandemic ceasing in clinic appointments control arm recruitment was discontinued. Patients who choose not to participate were invited to complete a control questionnaire 12 months after clinic related pandemic changes were made, including those who initially joined the control arm.

Control group

Active

Outcomes

Primary outcome [1]

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]

Baseline, 6 months (primary endpoint) and 12 months.

Secondary outcome [1]

a) SLHD Patient satisfaction survey - online survey
This survey is designed for this district to evaluate service delivery in all specialities.

Timepoint [1]

Baseline, 6 and 12 months

Secondary outcome [2]

b) CQOLCF Scale - online survey
Caregiver quality of life survey

Timepoint [2]

6 and 12 months

Secondary outcome [3]

c) CFQ-R - online survey
Validated survey to assess CF participant quality of life

Timepoint [3]

Baseline, 6 and 12 months

Secondary outcome [4]

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]

Baseline, 6 and 12 months

Secondary outcome [5]

e) Telehealth satisfaction scale - online survey

Timepoint [5]

6 and 12 months

Secondary outcome [6]

f) RPA CF specific telehealth satisfaction survey - online survey
This was designed specifically for this study

Timepoint [6]

6 and 12 months

Secondary outcome [7]

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]

6 and 12 months

Secondary outcome [8]

Cost assessment for a patient to attend clinic
To assess overall cost of attending clinic
This was designed specifically for this study

Timepoint [8]

baseline, 6 and 12 months

Eligibility

Key inclusion criteria

All patients within the CF clinic were invited to participate. All patients partaking in this trial will have cystic fibrosis.

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

12/02/2020

Actual

7/02/2020

Date of last participant enrolment

Anticipated

Actual

31/05/2020

Date of last data collection

Anticipated

Actual

31/07/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment postcode(s) [1]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Sydney Local Health District

Address [1]

Level 11, KGV Building
Missenden Road, Camperdown, NSW 2050

Country [1]

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]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

Research Ethics and Governance Office (REGO)
RPAH Medical Centre
Suite 210A,  Level 2
100 Carillon Avenue
NEWTOWN NSW 2042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/11/2019

Ethics approval number [1]

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

Ms Jody Bell

Address

Royal Prince Alfred, Level 11, KGV Building Missenden Road, Camperdown, NSW 2050

Country

Australia

Phone

+61 2 9515 4970

Fax

[email protected]

Contact person for public queries

Name

Jody Bell

Address

Royal Prince Alfred, Level 11, KGV Building Missenden Road, Camperdown, NSW 2050

Country

Australia

Phone

+61 2 9515 4970

Fax

[email protected]

Contact person for scientific queries

Name

Sheila Sivam

Address

Royal Prince Alfred, Level 11, KGV Building Missenden Road, Camperdown, NSW 2050

Country

Australia

Phone

+61 2 9515 8195

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	Quality of home spirometry performance amongst adults with cystic fibrosis.	2022	https://dx.doi.org/10.1016/j.jcf.2021.10.012

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically