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Trial registered on ANZCTR


Registration number
ACTRN12618000012279
Ethics application status
Approved
Date submitted
30/11/2017
Date registered
10/01/2018
Date last updated
11/12/2018
Date data sharing statement initially provided
11/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Positive Expiratory Pressure Therapy Recorder for Assessing Compliance (PEPtrac) - Initial Evaluation in Adults with Cystic Fibrosis..
Scientific title
Positive Expiratory Pressure Therapy Recorder for Assessing Compliance (PEPtrac) - Initial Evaluation in adults with Cystic Fibrosis.
Secondary ID [1] 293495 0
None
Universal Trial Number (UTN)
U1111-1206-0053
Trial acronym
PEPtrac-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 305679 0
Condition category
Condition code
Human Genetics and Inherited Disorders 304900 304900 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will use the PEPtrac device attached and operating with either the PariPEP S, Aerobika or Acapella DH. Participants will be able to choose which one of the three devices they would like to use. Recruitment is limited to 6 participants per device. Participants will perform at least one treatment session per day over the one week study period. Participants may elect to do more than one treatment session per day if clinically indicated based on participant self-assessment and/or physiotherapist opinion. There is no upper limit to the number of treatment sessions able to be performed each day. Treatments will be self-administered at home. The PariPEP will be used for 6 sets of 15 breaths, aiming for a mid-expiratory pressure of 10-20cmH2O. The Aerobika and Acapella will be used for 4 sets of 15 breaths, with a resistance setting than allows a slightly active expiration with inspiratory:expiratory ratio of 1:3-4. Treatment sessions will last approximately 15 minutes. The PEPtrac will be operating in 'research' mode which means participants do not see the duration of treatment or pressures recorded. Participants will also complete a treatment diary entry at the end of each treatment session, recording the start and finish times and number of breaths and cycles performed.
Intervention code [1] 299732 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304094 0
Comparison of the PEPtrac data versus participant self-reports via a treatment diary for number of recorded sessions.
Timepoint [1] 304094 0
After one week of treatment
Primary outcome [2] 304172 0
Comparison of the PEPtrac data versus participant self-reports via a treatment diary for number of recorded breaths and cycles for each treatment session.
Timepoint [2] 304172 0
After one week of treatment
Secondary outcome [1] 340937 0
Participant reported ease of use of the PEPtrac via purpose-specific questionnaire developed by the investigators.
Timepoint [1] 340937 0
After one week of treatment.

Eligibility
Key inclusion criteria
Diagnosis of cystic fibrosis, attending the Royal Adelaide Hospital Adult Cystic Fibrosis Service
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent, inability to understand written English, post lung transplantation, recent positive culture of Burkholderia cepacia or Non-Tuberculosis Mycobacteria, current inpatient, current participation in an interventional trial where modification of their airway clearance technique would be considered a protocol violation, any condition which is considered a contraindication to PEP/OPEP therapy.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Participants will be able to choose which airway clearance device they use with the PEPtrac. A maximum of 6 participants may use each time of airway clearance device.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample of convenience was selected for this initial exploratory study.(n=18). Data will be summarised descriptively. Systematic differences and variability will be determined by plotting differences between the PEPtrac recordings and participant diaries for: number of treatment sessions recorded and with-in treatment data (treatment duration, number of cycles, number of breaths).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/01/2018
Actual
16/02/2018
Date of last participant enrolment
Anticipated
30/06/2018
Actual
25/09/2018
Date of last data collection
Anticipated
7/07/2018
Actual
2/10/2018
Sample size
Target
18
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9470 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 18197 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 298112 0
Hospital
Name [1] 298112 0
The Royal Adelaide Hospital
Country [1] 298112 0
Australia
Funding source category [2] 298113 0
University
Name [2] 298113 0
La Trobe University
Country [2] 298113 0
Australia
Primary sponsor type
Individual
Name
Nathan Ward
Address
c/o Physiotherapy
8E055.08
The Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 297192 0
Individual
Name [1] 297192 0
Kathy Stiller
Address [1] 297192 0
7F060
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country [1] 297192 0
Australia
Secondary sponsor category [2] 297193 0
Individual
Name [2] 297193 0
Bruce Ward
Address [2] 297193 0
University of Adelaide
School of Physical Sciences
North Terrace
Adelaide
SA 5000
Country [2] 297193 0
Australia
Secondary sponsor category [3] 297194 0
Individual
Name [3] 297194 0
Amanda Kenyon
Address [3] 297194 0
c/o Physiotherapy
8E055.08
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country [3] 297194 0
Australia
Secondary sponsor category [4] 297195 0
Individual
Name [4] 297195 0
Prof Anne Holland
Address [4] 297195 0
La Trobe University Clinical School
Alfred Health
Level 4
The Alfred Centre
99 Commercial Rd
Melbourne
Vic 3004
Country [4] 297195 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299131 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 299131 0
Level 4
Women's Health Centre
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 299131 0
Australia
Date submitted for ethics approval [1] 299131 0
09/11/2017
Approval date [1] 299131 0
24/11/2017
Ethics approval number [1] 299131 0
HREC/17/RAH/270
Ethics committee name [2] 299132 0
La Trobe University University Human Ethics Committee
Ethics committee address [2] 299132 0
David Myers East
Level 2, 224
La Trobe University
Plenty Rd and Kingsbury Drive
Bundoora
Vic 3086
Ethics committee country [2] 299132 0
Australia
Date submitted for ethics approval [2] 299132 0
11/12/2017
Approval date [2] 299132 0
Ethics approval number [2] 299132 0
Ethics committee name [3] 299243 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [3] 299243 0
Research Services
University of Adelaide
North Terrace
Adelaide
SA 5005
Ethics committee country [3] 299243 0
Australia
Date submitted for ethics approval [3] 299243 0
07/12/2017
Approval date [3] 299243 0
14/12/2017
Ethics approval number [3] 299243 0
32307

Summary
Brief summary
This trial aims to determine the ability of the PEPtrac to record airway clearance sessions performed at home by adults with cystic fibrosis utilising commonly used positive pressure airway clearance devices when compared to participant self-reports. Participants will use the PEPtrac and an airway clearance device for a one week period, performing a treatment session at least once daily At the completion of each treatment session, participants will complete a treatment diary entry. After one week, participants will also complete a questionnaire examining their experience of using the PEPtrac and any suggested design modifications that they may have.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79406 0
Mr Nathan Ward
Address 79406 0
c/o Physiotherapy
8E055.08
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country 79406 0
Australia
Phone 79406 0
+61 8 7074 2855
Fax 79406 0
Email 79406 0
[email protected]
Contact person for public queries
Name 79407 0
Nathan Ward
Address 79407 0
c/o Physiotherapy
8E055.08
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country 79407 0
Australia
Phone 79407 0
+61 8 7074 2855
Fax 79407 0
Email 79407 0
[email protected]
Contact person for scientific queries
Name 79408 0
Nathan Ward
Address 79408 0
c/o Physiotherapy
8E055.08
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country 79408 0
Australia
Phone 79408 0
+61 8 7074 2855
Fax 79408 0
Email 79408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Collated results on participant feedback will be presented. Individual treatment session data may be presented in future presentations/publications.


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.