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Trial registered on ANZCTR


Registration number
ACTRN12615000599572
Ethics application status
Approved
Date submitted
26/05/2015
Date registered
9/06/2015
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Date results information initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
SMART CF - A smartphone application for reporting symptoms in adults with cystic fibrosis
Scientific title
In adults with cystic fibrosis, what is the effect of a smartphone application used to report symptoms versus usual care on exacerbations requiring intravenous antibiotics, healthcare utilisation, lung function, quality of life, anxiety and depression, nutritional status, medication adherence and absenteeism and presenteeism.
Secondary ID [1] 286807 0
Nil known
Universal Trial Number (UTN)
U1111-1170-6087
Trial acronym
SMART CF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 295181 0
Condition category
Condition code
Respiratory 295432 295432 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Smartphone application. Participants will use their own smartphone to answer 10 questions relating to their respiratory symptoms and 2 questions relating to their emotional wellbeing on a weekly basis (or sooner if they choose) for a 12 month period. Answers will be emailed securely to the CF team and contact will be made with the participant if the responses indicate a potential exacerbation.
Intervention code [1] 291967 0
Treatment: Devices
Comparator / control treatment
Usual care. Participants will attend routine CF clinic visits, with the ability to contact the CF team at any time if an earlier review is required.
Control group
Active

Outcomes
Primary outcome [1] 295163 0
Number of exacerbations requiring intravenous antibiotics (IVABs). This will be collected from the participants medical record.
Timepoint [1] 295163 0
The primary timepoint will be 12 months (end of the intervention period).
Primary outcome [2] 295164 0
Number of intravenous antibiotic days. This will be collected from the participants medical record.
Timepoint [2] 295164 0
The primary timepoint will be 12 months (end of the intervention period).
Secondary outcome [1] 314914 0
Lung Function measured via spirometry (according to ATS/ERS criteria)
Timepoint [1] 314914 0
0, 6 and 12 months (from commencement of intervention period).
Secondary outcome [2] 314915 0
Cystic Fibrosis Questionnaire - Revised
Timepoint [2] 314915 0
0, 6 and 12 months (from commencement of intervention period).
Secondary outcome [3] 314916 0
Hospital Anxiety and Depression Scale
Timepoint [3] 314916 0
0, 6 and 12 months (from commencement of intervention period).
Secondary outcome [4] 314917 0
Nutional status measured via body mass index
Timepoint [4] 314917 0
0, 6 and 12 months (from commencement of intervention period).
Secondary outcome [5] 314918 0
Treatment Adherence Questionnaire - CF
Timepoint [5] 314918 0
0, 6 and 12 months (from commencement of intervention period).
Secondary outcome [6] 314919 0
Absenteeism and Presenteeism
Timepoint [6] 314919 0
0, 6 and 12 months (from commencement of intervention period).
Secondary outcome [7] 314920 0
System Usability measured via the System Usability Scale, and application data including frequency/day/time of use
Timepoint [7] 314920 0
0, 6 and 12 months (from commencement of intervention period).
Secondary outcome [8] 315075 0
Time (in days from baseline) to first exacerbation.
Timepoint [8] 315075 0
Collected from participants medical record at 12 months (from commencement of intervention period).
Secondary outcome [9] 315076 0
If lung function returned to baseline following each exacerbation requiring IVABs.
Timepoint [9] 315076 0
Collected from participants medical record at 12 months (from commencement of intervention period).
Secondary outcome [10] 315077 0
Number of hospital admissions and admission days.
Timepoint [10] 315077 0
Collected from participants medical record at 12 months (from commencement of intervention period).
Secondary outcome [11] 315078 0
Number of courses and days of oral and inhaled antibiotics.
Timepoint [11] 315078 0
Collected from participants medical record at 12 months (from commencement of intervention period).
Secondary outcome [12] 315079 0
Number of CF clinic visits and clinical phone calls.
Timepoint [12] 315079 0
Collected from participants medical record at 12 months (from commencement of intervention period).
Secondary outcome [13] 315080 0
Cost of antibiotic treatment.
Timepoint [13] 315080 0
Collected from participants medical record at 12 months (from commencement of intervention period), and verified with hospital phramacy and finance departments.
Secondary outcome [14] 315081 0
Cost of hospital admissions.
Timepoint [14] 315081 0
Collected from participants medical record at 12 months (from commencement of intervention period), and verified with hospital phramacy and finance departments.

Eligibility
Key inclusion criteria
Diagnosis of CF; aged 18 years or older; under the care of the Sir Charles Gairdner Hospital (SCGH) CF team; clinically stable at time of recruitment; exacerbation requiring IVABs in the preceding 12 months.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lung transplantation or currently listed for lung transplantation; current pregnancy; inability to provide informed consent.

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)
Individuals will be identified from those who are under the care of the SCGH CF team and meet the inclusion criteria. Individuals will be provided with the Participant Information Sheet and contacted 1 week later to determine whether or not they would like to participate.

Partcipants will attend a baseline visit and the relevant outcome measures will be collected. They will then be randomised to either the smartphone application group or the control (usual care) group. The NHMRC randomisation system will be used in this trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The NHMRC randomisation system will be used in this trial. The randomisation sequence will be stratified according to gender and location (metropolitan or rural and remote), as well as use of ivacaftor.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Intention to treat analysis
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
To investigate the difference in the number of IVAB courses between the two groups, assuming a within group standard deviation of 1.21 (based on IVAB usage at the SCGH CF centre during 2013 and 2014), a sample size of 23 in each group will be required to detect a difference of one exacerbation requiring IVABs per participant, with 80% power and a significance level of p < 0.05. To account for any loss to follow up or drop out, we will recruit an additional seven individuals per group for a total sample size of 60.

Between-group analysis will be performed using an independent t-test (parametric data) or Mann Whitney U test (non-parametric data). Within group changes in outcome measures collected at each visit will be assessed using one-way repeated measures analysis of variance (parametric data) or Friedman’s test (non-parametric data). Time to first pulmonary exacerbation will be analysed using a Kaplan–Meier survival analysis.

Recruitment
Recruitment status
Completed
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)
WA
Recruitment hospital [1] 3835 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 9725 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 291348 0
Hospital
Name [1] 291348 0
Sir Charles Gairdner Hospital Research Advisory Committee
Address [1] 291348 0
Hospital Avenue, Nedlands, WA, 6009
Country [1] 291348 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue, Nedlands, WA, 6009
Country
Australia
Secondary sponsor category [1] 290026 0
University
Name [1] 290026 0
Curtin University
Address [1] 290026 0
Kent Street, Bentley, Perth
Western Australia, 6102.
Country [1] 290026 0
Australia
Other collaborator category [1] 278485 0
University
Name [1] 278485 0
Telemedicine, Burke Rehabilitation and Research Institute, Cornell University.
Address [1] 278485 0
785 Mamaroneck Ave, White Plains, NY 10605
Country [1] 278485 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292909 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 292909 0
Hospital Avenue, Nedlands, WA, 6009
Ethics committee country [1] 292909 0
Australia
Date submitted for ethics approval [1] 292909 0
26/05/2015
Approval date [1] 292909 0
13/08/2015
Ethics approval number [1] 292909 0
2015-030

Summary
Brief summary
Cystic fibrosis (CF) is the most common Caucasian genetic disease and has a reduced life expectancy of approximately 40 years of age. The decline in lung function in CF is accelerated by exacerbations. Severe exacerbations require treatment with intravenous antibiotics (IVABs), but of concern many do not regain the lung function they have lost following treatment. One of the major factors in this failure to regain lung function is the delay in time it takes for the individual with CF to present to the CF centre to report symptoms and commence treatment.

In collaboration with Curtin University and the Burke Rehabilitation and Research Institute in New York, USA, we have developed a smartphone application that can be used by participants to report their symptoms to the CF team at Sir Charles Gairdner Hospital on a weekly basis or sooner if they feel they need to. We will now aim to complete a 12 month randomised controlled trial in 60 participants, investigating the impact of using this smartphone application on the number of exacerbations requiring IVABs per participant, as well as other health outcomes and measures of healthcare utilisation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57614 0
Mr Jamie Wood
Address 57614 0
Physiotherapy Department
A Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA, 6009
Country 57614 0
Australia
Phone 57614 0
+61 8 9346 3333
Fax 57614 0
Email 57614 0
jamie.wood@health.wa.gov.au
Contact person for public queries
Name 57615 0
Mr Jamie Wood
Address 57615 0
Physiotherapy Department
A Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA, 6009
Country 57615 0
Australia
Phone 57615 0
+61 8 9346 3333
Fax 57615 0
Email 57615 0
jamie.wood@health.wa.gov.au
Contact person for scientific queries
Name 57616 0
Mr Jamie Wood
Address 57616 0
Physiotherapy Department
A Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA, 6009
Country 57616 0
Australia
Phone 57616 0
+61 8 9346 3333
Fax 57616 0
Email 57616 0
jamie.wood@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification; individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary