Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000801213
Ethics application status
Not yet submitted
Date submitted
14/09/2009
Date registered
15/09/2009
Date last updated
15/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Is Inspiratory Flow Rate (IFR) appropriate for the puffers patients use for their lung conditions, and will training them to achieve the appropriate IFR improve their shortness of breath and reduce their need for health services?
Scientific title
The Appropriateness of Inspiratory Flow Rate (IFR) of Patients with Respiratory Disease for the Inhaler Devices they use, and the Effect of Training on Improving IFR and Reducing Demand for Healthcare Services.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suboptimal use of Inhalers due to inappropriate Inspiratory Flow Rate 243707 0
Condition category
Condition code
Respiratory 239971 239971 0 0
Chronic obstructive pulmonary disease
Respiratory 239972 239972 0 0
Asthma
Public Health 239979 239979 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Training patients to achieve an appropriate Inspiratory Flow Rate (IFR) for the Inhaler Device they use. Verbal training is provided by a pharmacist while utilising an inspiratory flow meter, and is followed up by individualised written instructions on how to achieve the appropriate IFR range for each of the inhalers a patient is using. Verbal training would take between 5-10 minutes until the patient achieves appropriate IFR or the pharmacist determines that the patient is unable to achieve such IFR. Written instructions should be provided 1-2 days after verbal training is offered. All training is offered only once to participants.
Intervention code [1] 241246 0
Other interventions
Intervention code [2] 241291 0
Lifestyle
Comparator / control treatment
No training provided.
Control group
Active

Outcomes
Primary outcome [1] 240774 0
% patients with improved shortness of breath (SOB). This is measured on the Borg Dyspnoea Scale.
Timepoint [1] 240774 0
1 week, 2 week, 3 weeks, and 4 weeks after assessment of, or training on, IFR is provided.
Primary outcome [2] 240775 0
Emergency Departmemt (ED) presentation rate. This will be assessed by accessing patients' electronic records that show their presentation rate and admission details.
Timepoint [2] 240775 0
1 month, 2 months, and 3 months following IFR assessment/training.
Primary outcome [3] 240776 0
Average length of stay (in days). This will be assessed by accessing patients' electronic records that show their presentation rate and admission details.
Timepoint [3] 240776 0
Average of all hospital stays over the 3-months period following IFR assessment/training.
Secondary outcome [1] 257449 0
% patients achieving an IFR appropriate for the inhalers they use. This is determined by assessing patients' ability to achieve appropriate IFR, half an hour after training was offered by the pharmacist.
Timepoint [1] 257449 0
Half an hour after training is provided.
Secondary outcome [2] 257450 0
Number of hospital admissions. This will be assessed by accessing patients' electronic records that show their presentation rate and admission details.
Timepoint [2] 257450 0
Average over the 3-months period following IFR assessment/training.
Secondary outcome [3] 257576 0
Quality of Life as measured by the St George's Respiratory Questionnaire (SGRQ).
Timepoint [3] 257576 0
1 month after intervention.
Secondary outcome [4] 257577 0
Reliever Use Extent (RUE). This describes the extent to which a patient has been using their short acting B-agonist medications, for the relief of their shortness of breath.
Timepoint [4] 257577 0
Daily for 1 month after intervention.
Secondary outcome [5] 257578 0
Mortality rate.
Timepoint [5] 257578 0
3 months, 6 months, 12 months after intervention.

Eligibility
Key inclusion criteria
St Vincent’s Health patients older than 18 years of age with any respiratory disease, who use respiratory inhalers for the administration of their medications.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with active respiratory infection, as indicated by current treatment with short term antibiotic therapy. Long term prophylactic antibiotic therapy is not an exclusion criterion.

* Patients on current short term oral corticosteroids.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by coin tossing is used to allocate a patient to "intervention" group or "no intervention" group, if the patient does not achieve appropriate IFR for at least one inhaler they use, during IFR assessment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243619 0
Self funded/Unfunded
Name [1] 243619 0
Kyrillos Guirguis
Country [1] 243619 0
Australia
Primary sponsor type
Individual
Name
Kyrillos Guirguis
Address
2nd Flr Daly Wing,
St Vincent's Hospital,
35 Victoria Pde,
Fitzroy 3065
Country
Australia
Secondary sponsor category [1] 237068 0
None
Name [1] 237068 0
Address [1] 237068 0
Country [1] 237068 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 243745 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 243745 0
Ethics committee country [1] 243745 0
Australia
Date submitted for ethics approval [1] 243745 0
18/09/2009
Approval date [1] 243745 0
Ethics approval number [1] 243745 0

Summary
Brief summary
Many patients with lung disease who use inhalers (puffers) are unable to generate enough strength when breathing in through their puffers. Often, they breathe too hard with some puffers. This breathing strength is generally known as the Inspiratory Flow Rate (IFR). Inappropriate IFR leads to sub-optimal use of puffers, compromising the effectiveness of patients' treatment. This study aims to know how common this problem is and to test the idea that training patients to achieve appropriate IFR leads to better outcomes. These outcomes include improved breathing, better quality of life, and reduced emergency department visits, as well as shorter hospital stays.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30170 0
Address 30170 0
Country 30170 0
Phone 30170 0
Fax 30170 0
Email 30170 0
Contact person for public queries
Name 13417 0
Kyrillos Guirguis
Address 13417 0
2nd Flr Daly Wing,
St Vincent's Hospital,
35 Victoria Pde,
Fitzroy 3065
Country 13417 0
Australia
Phone 13417 0
+61 3 9288 2392
Fax 13417 0
+61 3 9288 2192
Email 13417 0
kyrillos.guirguis@svhm.org.au
Contact person for scientific queries
Name 4345 0
Kyrillos Guirguis
Address 4345 0
2nd Flr Daly Wing,
St Vincent's Hospital,
35 Victoria Pde,
Fitzroy 3065
Country 4345 0
Australia
Phone 4345 0
+61 3 9288 2392
Fax 4345 0
Email 4345 0
kyrillos.guirguis@svhm.org.au

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
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Documents added automatically
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