Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000736842
Ethics application status
Approved
Date submitted
9/07/2012
Date registered
10/07/2012
Date last updated
14/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Therapist-made bubble-positive expiratory pressure: a survey of physiotherapists in Australia
Scientific title
Use of the Bottle/Bubble Positive Expiratory Pressure (PEP) device by Physiotherapists in Australian hospitals for treating people with respiratory disorders.
Secondary ID [1] 280801 0
Nil
Universal Trial Number (UTN)
U1111-1132-5334
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physiotherapists in Australia treating people with Respiratory Disorders. 286862 0
Condition category
Condition code
Respiratory 287186 287186 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will use a questionnaire that will be sent to all specialist paediatric hospitals in Australia and to a representative sample of public and private hospitals in Australia. The physiotherapists working in these hospitals will be invited to participate in the study.

The aims of the questionnaire are to determine: 1) the extent of the Bottle/Bubble PEP use in Australia; 2) the proposed rationale for its use; 3) for which patients Bottle/Bubble PEP is used and; 4) why it is chosen rather than other PEP devices.

The questionnaire is to be returned 1 month after it is mailed out. If the questionnaire is not returned after a month, respondents will be invited again to participate in the study. Maximum length of this study is 6 months.
Intervention code [1] 285232 0
Not applicable
Comparator / control treatment
Uncontrolled.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287480 0
How widespread is the use of the Bottle/Bubble PEP device by physiotherapists in Australia.
Timepoint [1] 287480 0
1 month after questionnaire is sent.
Secondary outcome [1] 298257 0
The proposed rationale for the Bottle/Bubble PEP use
Timepoint [1] 298257 0
1 month after questionnaire is sent.
Secondary outcome [2] 298258 0
For which patients Bottle/Bubble PEP is used
Timepoint [2] 298258 0
1 month after questionnaire is sent.
Secondary outcome [3] 298259 0
Why is the Bottle/Bubble PEP chosen rather than other devices.
Timepoint [3] 298259 0
1 month after questionnaire is sent.

Eligibility
Key inclusion criteria
Physiotherapists in Australia that treat people with respiratory disorders.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Physiotherapists not treating people with respiratory disorders; non-physiotherapists

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/07/2012
Actual
25/07/2012
Date of last participant enrolment
Anticipated
Actual
31/05/2013
Date of last data collection
Anticipated
Actual
31/07/2013
Sample size
Target
121
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 285598 0
Hospital
Name [1] 285598 0
Prince of Wales Hospital
Country [1] 285598 0
Australia
Primary sponsor type
Individual
Name
Mary Santos
Address
Physiotherapy Department
Prince of Wales Hospital
Barker Street,
Randwick,
NSW, 2031
Country
Australia
Secondary sponsor category [1] 284430 0
Hospital
Name [1] 284430 0
Prince of Wales Hospital
Address [1] 284430 0
Barker Street,
Randwick,
NSW, 2031
Country [1] 284430 0
Australia
Other collaborator category [1] 276921 0
University
Name [1] 276921 0
University of Sydney
Address [1] 276921 0
East Street,
Lidcombe, NSW, 1825
Country [1] 276921 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287599 0
South Eastern Sydney Local Health District - Northern Sector Human Research Ethics Committee
Ethics committee address [1] 287599 0
Prince of Wales Hospital,
Barker Street,
Randwick, NSW, 2031
Ethics committee country [1] 287599 0
Australia
Date submitted for ethics approval [1] 287599 0
22/05/2012
Approval date [1] 287599 0
06/06/2012
Ethics approval number [1] 287599 0
1/12/0069

Summary
Brief summary
It is believed that physiotherapists in Australia use the Bottle/Bubble PEP device to treat patients that have secretion clearance problems. It is unknown though to what extent it is used or the rationale behind its use. This questionnaire will assist in answering these questions at it will be sent to a representative sample of physiotherapists working in hospitals within Australia.
Trial website
Trial related presentations / publications
Publication of survey in Cardiopulmonary Physical Therapy Journal 2016; 27:3–10
Public notes

Contacts
Principal investigator
Name 34412 0
Ms Mary Desiree Santos
Address 34412 0
Physiotherapy Department Prince of Wales Hospital, Barker Street, Randwick, NSW, 2031
Country 34412 0
Australia
Phone 34412 0
+61293822671
Fax 34412 0
Email 34412 0
[email protected]
Contact person for public queries
Name 17659 0
Mary Desiree Santos
Address 17659 0
Physiotherapy Department
Prince of Wales Hospital,
Barker Street,
Randwick, NSW, 2031
Country 17659 0
Australia
Phone 17659 0
+61 2 93822671
Fax 17659 0
Email 17659 0
[email protected]
Contact person for scientific queries
Name 8587 0
Mary Santos
Address 8587 0
Physiotherapy Department
Prince of Wales Hospital,
Barker Street,
Randwick, NSW, 2031
Country 8587 0
Australia
Phone 8587 0
+61 2 93822671
Fax 8587 0
Email 8587 0
[email protected]

No information has been provided regarding IPD availability


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.