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Trial registered on ANZCTR


Registration number
ACTRN12620000311954p
Ethics application status
Submitted, not yet approved
Date submitted
31/01/2020
Date registered
6/03/2020
Date last updated
9/07/2021
Date data sharing statement initially provided
6/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Replacement of hospital clinic appointments with telehealth appointments delivered directly to the home for people with cystic fibrosis (CF)
Scientific title
Replacement of multi-disciplinary hospital clinic appointments with telehealth appointments delivered directly to the home for people with cystic fibrosis. A randomized controlled trial
Secondary ID [1] 300379 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 316004 0
Condition category
Condition code
Respiratory 314276 314276 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 314489 314489 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multi-disciplinary Telehealth appointments directly to the patient home.
Telehealth appointments will be a replacement of face to face appointments which occur every 1-3 months on average, depending on the clinical need.
Each multi-disciplinary appointment is 30-120 minutes in duration depending on the number of team members needing to see the individual and the waiting times to see the various health professionals
Participants in the intervention group will receive a minimum of 50% of their outpatient appointments via telehealth for a period of twelve months. At the discretion of the participant and their treating CF team, a higher percentage of appointments may be delivered via telehealth.
The participant will be reviewed by all members of the multi-disciplinary team that would otherwise be reviewing the participant if they were physically present at the clinic. The health professionals involved include; respiratory physician, nurse, dietitian, physiotherapist, gastroenterologist, endocrine nurse, social worker, clinical psychologist. Not all multi-disciplinary team members are required to see the individual at every appointment.
Intervention code [1] 316659 0
Treatment: Other
Comparator / control treatment
Usual care.
Usual care is physical attendance to the outpatient clinics at the cystic fibrosis specialist centre.
Control group
Active

Outcomes
Primary outcome [1] 322663 0
Composite score on the Treatment Burden Questionnaire (TBQ)
Timepoint [1] 322663 0
At randomisation
At twelve months after randomisation
Secondary outcome [1] 379228 0
Cost of Outpatient Care Questionnaire
Timepoint [1] 379228 0
At randomisation
At every clinic review (including face to face and telehealth reviews)
Secondary outcome [2] 379229 0
Telehealth Usability Questionnaire (TUQ)
Timepoint [2] 379229 0
At completion of every telehealth clinic review (intervention group only)
Secondary outcome [3] 379231 0
Lung function measured using Forced Expiratory Volume in 1 second (FEV1)
Timepoint [3] 379231 0
Baseline and every clinic visit (including face to face visits and telehealth visits)
Secondary outcome [4] 379232 0
Nutrition measured using Body Mass Index (BMI)
Each participant receives a standard bathroom scale (TANITA Model HD382), a tape measure and standardised instruction sheets for measuring of height and weight. Height and weight measurements will be used to calculate BMI
Timepoint [4] 379232 0
Baseline and every clinic visit (including face to face visits and telehealth visits)
Secondary outcome [5] 379233 0
Appointment Duration (minutes)
For telehealth appointments, appointment duration will be calculated using the time that the participant logged into the telehealth system and at what time they disconnected from the system.
For face to face visits, part of one of the questionnaires used includes a field for appointment duration and travel time, these fields are both manually entered by the participant
Timepoint [5] 379233 0
Baseline and every clinic visit (including face to face visits and telehealth visits)
Secondary outcome [6] 379234 0
Number of protocol defined Pulmonary exacerbations.
The full study protocol defines pulmonary exacerbations as follows:
o Paediatric: The presence of one of the major criteria alone or two of the minor signs/symptoms with fulfilment of symptom duration
MAJOR CRITERIA
• (decrease in forced expiratory volume in one second [FEV1] of > 10% from best baseline within last 6 months unresponsive to salbutamol
• oxygen saturation less than 90% on room air or at least 5% decline from baseline;
• new lobar infiltrates or atelectasis on chest X-ray;
• hemoptysis (more than streaks on more than one occasion in the last week) or two
MINOR SYMPTOMS/SIGNS (two minor signs/symptoms are required with duration criteria in the absence of major criteria:
• increased work of breathing or respiratory rate;
• new or increased adventitial sounds on lung exam;
• weight loss >5% of body weight or decrease across 1 major percentile for age in past 6 months
• increased cough;
• decreased exercise tolerance or level of activity
• increased chest congestion or change in sputum for
SIGN/SYMPTOM DURATION: (required with two minor symptoms/signs in absence of major criteria)
• Duration of symptom/sign > 5 days or significant symptom severity

o Adult: The Modified FUCs criteria
An exacerbation will be defined as the need for additional antibiotic treatment as indicated by a recent change in at least two of the following:
• Change in sputum volume or colour
• Increased Cough
• Increased malaise, fatigue or lethargy
• Anorexia or weight loss
• Decrease in pulmonary function by 10% or more OR Radiographic changes
• Increased dyspnoea
Timepoint [6] 379234 0
Baseline and every clinic visit (including face to face visits and telehealth visits)

Eligibility
Key inclusion criteria
- Adults and children with diagnosis of CF confirmed with sweat test, abnormal nasal potential difference and/or genetic testing
- Clinical care managed by a CF specialist multidisciplinary team at one of the participating hospitals
- Age > 6 months
- Participants with resting SpO2 < 95% on room air will require a home SpO2 monitor for inclusion in the trial (as SpO2 measurement would form part of usual clinical care in this group)
- Clinically stable without antibiotic treatment for a pulmonary exacerbation in the two weeks prior to the screening visit
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- FEV1 <30%
- Unable to receive all prescribed medications without physically attending CF centre
- Lack of internet availability in the home or other reason for inability to connect to NSW Health teleconferencing platform
- Technological limitation to use of portable spirometer (e.g. incompatible device)
- Inability to speak and read the English language well enough to complete questionnaires

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
This trial had to be withdrawn before commencing due to the impact of the COVID19 pandemic on the models of care proposed for the control and treatment arms of this randomised control trial
Date of first participant enrolment
Anticipated
24/08/2020
Actual
Date of last participant enrolment
Anticipated
28/06/2021
Actual
Date of last data collection
Anticipated
28/06/2022
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15721 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 15722 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 29142 0
2031 - Randwick
Recruitment postcode(s) [2] 29143 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 304803 0
Charities/Societies/Foundations
Name [1] 304803 0
The HCF Research Foundation
Country [1] 304803 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road
Macquarie Park
NSW 2109
Country
Australia
Secondary sponsor category [1] 305124 0
None
Name [1] 305124 0
Address [1] 305124 0
Country [1] 305124 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305218 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 305218 0
Ethics committee country [1] 305218 0
Australia
Date submitted for ethics approval [1] 305218 0
02/03/2020
Approval date [1] 305218 0
Ethics approval number [1] 305218 0

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

Contacts
Principal investigator
Name 99650 0
Mr Michael Doumit
Address 99650 0
Department of Health Professions
75 Talavera Road
Macquarie University
Macquarie Park
NSW 2109
Country 99650 0
Australia
Phone 99650 0
+61 2 9850 9033
Fax 99650 0
Email 99650 0
michael.doumit@mq.edu.au
Contact person for public queries
Name 99651 0
Michael Doumit
Address 99651 0
Department of Health Professions
75 Talavera Road
Macquarie University
Macquarie Park
NSW 2109
Country 99651 0
Australia
Phone 99651 0
+61 2 9850 9033
Fax 99651 0
Email 99651 0
michael.doumit@mq.edu.au
Contact person for scientific queries
Name 99652 0
Michael Doumit
Address 99652 0
Department of Health Professions
75 Talavera Road
Macquarie University
Macquarie Park
NSW 2109
Country 99652 0
Australia
Phone 99652 0
+61 2 9850 9033
Fax 99652 0
Email 99652 0
michael.doumit@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is not appropriate to make Individual participant data available to the public.
All results of the study will be presented as de-identified group data


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.