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Trial registered on ANZCTR


Registration number
ACTRN12613000929707
Ethics application status
Approved
Date submitted
31/03/2013
Date registered
22/08/2013
Date last updated
11/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving adherence with PEP (Positive end expiratory) chest physiotherapy in children with cystic fibrosis though the use of an electronic device, the PEP PT (Personal trainer)
Scientific title
Does the use of the PEP PT (a computer enhanced positive end expiratory chest physiotherapy device) in children with cystic fibrosis improve adherence with chest physiotherapy compared with standard PEP chest physiotherapy
Secondary ID [1] 282214 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PEPSTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 288734 0
Condition category
Condition code
Respiratory 289090 289090 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 290187 290187 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PEP Personal Trainer is a newly developed device which has been designed to provide both PEP (positive end expiratory pressure) chest physiotherapy and some key additional functions. A PEP mask is held to the face by the user. The user inhales gently through the mask and then exhales against resistance because of a one way valve and resistor. This provides pressure back down their airway. It is suggested that the subject reach and maintain 10-20cm water pressure for 3 seconds. This is a standard and well proven form of chest physiotherapy. During a session a user will normal perform 100 exhalations. The PEP PT measures the pressure associated with each blow using a electronic sensor contained within the mask. The PEP PT connects wirelessly to a tablet device. The key features of the device include: 1. An alarm to remind the subject to perform their PEP (typically done twice daily), 2. The screen displays the ideal pressure curve which the subject can follow to ensure an ideal technique, 3. The subject can play games on the device which again require and encourage an ideal technique (for example piloting a space ships which collects asteroids), 4. The device counts the number of blows performed and provides prompts and encouragement, 5. The devices scores each blow and assigns a point for each effective blow (PEP points) which the child's parent can redeem for rewards, 6. The device stores information about both adherence and technique which can be reviewed at consultations. In this trial subjects will be randomised to either the PEP PT or a control device which measures adherence and technique but does not connect to a screen or have the other features. The subjects use either device for 6 weeks. Subjects assigned to the control device then use the PEP PT for six weeks (wait list control method).
Intervention code [1] 286830 0
Treatment: Devices
Comparator / control treatment
A control device which also provides PEP, measures adherence and assesses technique, but does not provide the other functions including feedback will be used as the control.
Control group
Active

Outcomes
Primary outcome [1] 289200 0
Adherence with chest physiotherapy as measured by the PEP device (for example if the patient is prescribed 100 blows in the morning and one hundred at night and they perform 100 blows in the morning and 50 at night, they will be assigned 100% adherence for the morning and 50% for the night).
Timepoint [1] 289200 0
6 weeks
Secondary outcome [1] 302023 0
Technique with PEP. Each blow will be assessed against set criteria. The device will count the number of "good" blows. The number of "good" blows with the PEP PT compared to the control device with be the secondary outcome.
Timepoint [1] 302023 0
6 weeks

Eligibility
Key inclusion criteria
Cystic Fibrosis, using PEP and currently well.
Minimum age
4 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
FEV1 less than 40% predicted

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)
Participants attending the Mater Children Cystic Fibrosis clinic will be invited to enrol. Following providing informed written consent participants will be randomly allocated to one of the two intervention arms. A research assistant will prepare study packs which contain study allocation. Subjects will be divided into one of 6 groups based upon their age and lung function (3 age groups and 2 lung function groups) - minimisation to help ensure balance in both groups. There will be equal numbers of control and intervention in each group. The research assistant will be a computer random number generator to allocate the numbers in blocks of 2 or 4 subjects. Subjects in each group will be given a folder in sequential order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence generation. There will be equal numbers in 3 age groups (4-8, 8-12 and 12-16y). The two older groups will be divided into those with FEV1 above and below 80% predicted.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Wait list control. Following randomisation subjects will be allocated to either the intervention for 6 weeks or the control device for 6 weeks and then the intervention for the following 6 weeks.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Advice from our statistician suggests that 35 subjects would allow a 10% improvement in adherence to be detected, in a population with a 20% standard deviation in adherence, with a power of 0.8 and an alpha of 0.05. Thus we plan to recruit 36 subjects.

Recruitment
Recruitment status
Not yet 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)
QLD
Recruitment hospital [1] 819 0
Mater Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 6637 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 286977 0
Hospital
Name [1] 286977 0
Golden Casket Grant, Mater Children's Hospital
Address [1] 286977 0
Raymond Terrace
South Brisbane QLD 4101
Australia
Country [1] 286977 0
Australia
Primary sponsor type
Hospital
Name
Mater Health Service
Address
Raymond Terrace
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 285767 0
None
Name [1] 285767 0
Address [1] 285767 0
Country [1] 285767 0
Other collaborator category [1] 277340 0
University
Name [1] 277340 0
University of Queensland
Address [1] 277340 0
St Lucia
Brisbane 4067
Queensland
Country [1] 277340 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289028 0
Mater Health Services HREC
Ethics committee address [1] 289028 0
Raymond Terrace
South Brisbane QLD 4101
Ethics committee country [1] 289028 0
Australia
Date submitted for ethics approval [1] 289028 0
13/05/2013
Approval date [1] 289028 0
Ethics approval number [1] 289028 0

Summary
Brief summary
This trial is investigating whether a new physiotherapy device used in children with cystic fibrosis meets the needs of clients better than the current technology and thus is used more often and effectively used than the standard device. Cystic fibrosis is a genetic condition associated with significant lung disease. Chest physiotherapy helps move infected secretions out the lung and is a standard part of daily therapy. However, adherence with this therapy is low for many reasons. This device has been designed to address many of these problems and hopefully will improve adherence. The type of physiotherapy being addressed in thus study is call PEP (which stands for positive expiratory pressure) and would be well known to patients and those involve in patient care. The prototype device measures the pressure produced during each blow. The active device connects wirelessly to a tablet computer. Each blow is displayed on the screen. There are features including a game controlled by the blows, an alarm function, points which are earned with each correct blow which can be redeemed and the capacity to download adherence data at clinical reviews. Subjects will be randomly allocated to use either the new device or a control device which measures adherence but otherwise looks the same as a normal device for 6 weeks. Subjects will be aged 4-16 years. The main outcome will be adherence with the device. Those who don't get to use the device in the first 6 weeks will get to use it during a second 6 week period.
Trial website
NA
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38858 0
Dr Scott Burgess
Address 38858 0
Department of Respiratory and Sleep Medicine
Mater Children's Hospital
Raymond Terrace
South Brisbane QLD 4101
Country 38858 0
Australia
Phone 38858 0
61 7 3163 8382
Fax 38858 0
Email 38858 0
scott.burgess@mater.org.au
Contact person for public queries
Name 38859 0
Dr Scott Burgess
Address 38859 0
Department of Respiratory and Sleep Medicine
Mater Children's Hospital
Raymond Terrace
South Brisbane QLD 4101
Country 38859 0
Australia
Phone 38859 0
61 7 3163 8382
Fax 38859 0
Email 38859 0
scott.burgess@mater.org.au
Contact person for scientific queries
Name 38860 0
Dr Scott Burgesss
Address 38860 0
Department of Respiratory and Sleep Medicine
Mater Children's Hospital
Raymond Terrace
South Brisbane Q 4101
Country 38860 0
Australia
Phone 38860 0
61 7 3163 8382
Fax 38860 0
Email 38860 0
scott.burgess@mater.org.au

No information has been provided regarding IPD availability
Summary results
No Results