Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001478202
Ethics application status
Approved
Date submitted
6/12/2017
Date registered
4/09/2018
Date last updated
8/08/2019
Date data sharing statement initially provided
8/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inhaler technique mastery and maintenance in general medical practitioners: Easy Low Instruction Over Time (Dr ELIOT)
Scientific title
Inhaler technique mastery and maintenance in general medical practitioners: Easy Low Instruction Over Time (Dr ELIOT)
Secondary ID [1] 293365 0
None
Universal Trial Number (UTN)
U1111-1205-1092
Trial acronym
Dr ELIOT
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Poor use of inhaler devices by health care professionals (specifically general medical practitioners) 305772 0
Condition category
Condition code
Respiratory 304996 304996 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves an intervention that is delivered on two occasions, one month apart (at Visit 1 and Visit 2). Each visit will take no longer than ten minutes.
The intervention: At Visit 1, participants are given one of two placebo inhalers and are asked to use the inhaler. If they are not able to demonstrate correct inhaler technique, they will receive education in the form of written information; if then are still not able to use the inhaler after the written information, they will be shown a video on device technique and if following this they are still not able to demonstrate correct inhaler technique they will be given individualised education by the researcher. The same will be repeated for the other device.
The same process (intervention) will be delivered with the same two devices at Visit 2 (1 month after Visit 1).
The intervention will be delivered by researcher assistants from the Woolcock Institute of Medical Research. The two inhalers that will be used are Turbuhalers and Spiromax inhalers. Written instructions for their use have been developed by the research team and based on product information that is available to patients. Video instructions on inhaler use that will be used are publicly available on the National Asthma Council website for health care professional and patient use.
The cross over nature of the study is in reference to GPs being asked to demonstrate use of 2 devices, one after the other. In consideration of the fact that receiving instruction on the use of the first inhaler may positively influence the intuitive use of the second inhaler, GPs will be randomly allocated to use of either inhaler first to accomodate for this bias.
To ensure fidelity to the intervention, GPs inhaler technique is assessed by the researchers following each level of education until inhaler technique is mastered.
The Turbuhaler placebo devices are empty and contain no active ingredients. The spiromax devices contains Lactose monohydrate with approximately 10mg delivered per inhalation.
Intervention code [1] 299800 0
Behaviour
Comparator / control treatment
The two devices, Turbuhaler and Spiromax will serve as comparators.
Control group
Active

Outcomes
Primary outcome [1] 304165 0
The percentage of participants maintaining device mastery for SPIROMAX vs. TURBUHALER. Inhaler technique checklists designed specifically for this study will be used to assess mastery of devices.
Timepoint [1] 304165 0
At Visit 1 (t=0) and Visit 2 (t=1 month)
Primary outcome [2] 307274 0
• The percentage of participants achieving device mastery by level 1 training process that is superior for SPIROMAX compared to TURBUHALER. Device mastery is determined by no incorrect steps being performed as determined by the inhaler technique checklist that has been developed specifically for this study.
Timepoint [2] 307274 0
At Visit 1 (t=0) and Visit 2(t=1 month)
Primary outcome [3] 307275 0
• The percentage of participants achieving device mastery by level 2 training process that is superior for SPIROMAX compared to TURBUHALER. Device mastery is determined by no incorrect steps being performed as determined by the inhaler technique checklist that has been developed specifically for this study.
Timepoint [3] 307275 0
at Visit 1(t=0) and Visit 2 (t=1 month)
Secondary outcome [1] 341125 0
• The difference in number and type of handling errors identified.
Inhaler technique checklists developed for this study will be used to determine handling errors.
Timepoint [1] 341125 0
Visit 1 (t=0) and Visit 2(t=1 month)
Secondary outcome [2] 351324 0
• The number of levels required to achieve device mastery. (Primary)
Practice notes at delivery of intervention will determine how many levels of education were required to achieve device mastery.
Timepoint [2] 351324 0
At Visit 1(t=0) and Visit 2(t=1 month).
Secondary outcome [3] 351325 0

• The number and type of individual handling errors observed.(Primary).
Practice notes utilising the inhaler technique checklists will determine the number and type of handling errors observed.
Timepoint [3] 351325 0
At Visit 1(t=0) and Visit 2 (t=1 month)
Secondary outcome [4] 351326 0
• The Patient Satisfaction and Preference Questionnaire Q15 (PASAPQ) (Primary)
Timepoint [4] 351326 0
At Visit 1(t=0) and Vist 2 (t=1 month)

Eligibility
Key inclusion criteria
• Informed consent is obtained before conducting any study related procedures.
• The participant is a registered and practicing GP in NSW.
• The participant must be willing and able to comply with study restrictions and to remain at the study site for the required duration during the study period, and willing to return to the site for the follow-up evaluation as specified in this protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if they have asthma or COPD or use an inhaler themselves.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants all receive the same interventions but are randomised to receive them in different orders to ensure that mastery of the first device is taken into consideration with regards to mastery of the second.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The short-term maintenance (STM) population will include all randomised participants in Visit 2 at week 4. Short-term maintenance of device mastery can be assessed using the STM population. Participants who do not complete Level of Intuition 1 will be assessed as not having maintained mastery on the randomised device.
The mastery population will include all randomised participants in Visit 1. Achievement of device mastery can be assessed using the mastery population; Participants who do not complete the cross-over phase will be assessed as not having achieved mastery on any device where the assessment is incomplete.
The full analysis set (FAS) for this study will include all participants in the training and STM populations who complete both assessments (so permitting a paired analysis of results). This data set will be used for the assessment of relevant endpoints.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/08/2018
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
30/10/2019
Actual
Sample size
Target
232
Accrual to date
208
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297989 0
Commercial sector/Industry
Name [1] 297989 0
Teva Pharma Australia Pty Ltd
Country [1] 297989 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Road, Glebe, 2037, NSW
Country
Australia
Secondary sponsor category [1] 297261 0
None
Name [1] 297261 0
Address [1] 297261 0
Country [1] 297261 0
Other collaborator category [1] 279846 0
University
Name [1] 279846 0
University of Notre Dame
Address [1] 279846 0
160 Oxford Street, Darlinghurst, NSW, 2010
Country [1] 279846 0
Australia
Other collaborator category [2] 279847 0
Government body
Name [2] 279847 0
Central and Eastern Sydney PHN
Address [2] 279847 0
158 Liverpool Road, Ashfield, NSW, 2131
Country [2] 279847 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299028 0
University of Sydney, Human Ethics Committee
Ethics committee address [1] 299028 0
Ethics committee country [1] 299028 0
Australia
Date submitted for ethics approval [1] 299028 0
05/11/2017
Approval date [1] 299028 0
27/06/2018
Ethics approval number [1] 299028 0
2017/872
Ethics committee name [2] 301308 0
University of Notre Dame
Ethics committee address [2] 301308 0
Ethics committee country [2] 301308 0
Australia
Date submitted for ethics approval [2] 301308 0
Approval date [2] 301308 0
14/08/2018
Ethics approval number [2] 301308 0
018109S

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

Contacts
Principal investigator
Name 79038 0
Prof Sinthia Bosnic-Anticevich
Address 79038 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe, NSW, 2037
Country 79038 0
Australia
Phone 79038 0
+61 2 9114 0145
Fax 79038 0
+61 2 9114 0014
Email 79038 0
[email protected]
Contact person for public queries
Name 79039 0
Sinthia Bosnic-Anticevich
Address 79039 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe, NSW, 2037
Country 79039 0
Australia
Phone 79039 0
+61 2 9114 0145
Fax 79039 0
+61 2 9114 0014
Email 79039 0
[email protected]
Contact person for scientific queries
Name 79040 0
Sinthia Bosnic-Anticevich
Address 79040 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe, NSW, 2037
Country 79040 0
Australia
Phone 79040 0
+61 2 9114 0145
Fax 79040 0
+61 2 9114 0014
Email 79040 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3802Informed consent form    373995-(Uploaded-07-08-2019-13-46-04)-Study-related document.doc
3804Ethical approval    373995-(Uploaded-07-08-2019-13-46-04)-Study-related document.pdf



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.